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BACKGROUND: Peripheral arterial disease (PAD) is the obstruction or narrowing of the large arteries of the lower limbs, which can result in impaired oxygen supply to the muscle and other tissues during exercise, or even at rest in more severe cases. PAD is classified into five categories (Fontaine classification). It may be asymptomatic or various levels of claudication pain may be present; at a later stage, there may be ulceration or gangrene of the limb, with amputation occasionally being required. About 20% of people with PAD suffer from intermittent claudication (IC), which is muscular discomfort in the lower extremities induced by exertion and relieved by rest within 10 minutes; IC causes restriction of movement in daily life. Treatment for people with IC involves addressing lifestyle risk factors. Exercise is an important part of treatment, but supervised exercise programmes for individuals with IC have low engagement levels and high attrition rates. The use of mobile technologies has been suggested as a new way to engage people with IC in walking exercise interventions. The novelty of the intervention, low cost for the user, automation, and ease of access are some of the advantages mobile health (mhealth) technologies provide that give them the potential to be effective in boosting physical activity in adults. OBJECTIVES: To assess the benefits and harms of mobile health (mhealth) technologies to improve walking distance in people with intermittent claudication. SEARCH METHODS: The Cochrane Vascular Information Specialist conducted systematic searches of the Cochrane Vascular Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and CINAHL, and also searched the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov. The most recent searches were carried out on 19 December 2022. SELECTION CRITERIA: We included randomised controlled trials (RCTs) in people aged 18 years or over with symptomatic PAD and a clinical diagnosis of IC. We included RCTs comparing mhealth interventions to improve walking distance versus usual care (no intervention or non-exercise advice), exercise advice, or supervised exercise programmes. We excluded people with chronic limb-threatening ischaemia (Fontaine III and IV). DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were change in absolute walking distance from baseline, change in claudication distance from baseline, amputation-free survival, revascularisation-free survival. Our secondary outcomes were major adverse cardiovascular events, major adverse limb events, above-ankle amputation, quality of life, and adverse events. We used GRADE to assess the certainty of the evidence. MAIN RESULTS: We included four RCTs involving a total of 614 participants with a clinical diagnosis of IC. The duration of intervention of the four included RCTs ranged from 3 to 12 months. Participants were randomised to either mhealth or control (usual care or supervised exercise programme). All four studies had an unclear or high risk of bias in one or several domains. The most prevalent risk of bias was in the area of performance bias, which was rated high risk as it is not possible to blind participants and personnel in this type of trial. Based on GRADE criteria, we downgraded the certainty of the evidence to low, due to concerns about risk of bias, imprecision, and clinical inconsistency. Comparing mhealth with usual care, there was no clear evidence of an effect on absolute walking distance (mean difference 9.99 metres, 95% confidence interval (CI) -27.96 to 47.93; 2 studies, 503 participants; low-certainty evidence). None of the included studies reported on change in claudication walking distance, amputation-free survival, or revascularisation-free survival. Only one study reported on major adverse cardiovascular events (MACE) and found no clear difference between groups (risk ratio 1.37, 95% CI 0.07 to 28.17; 1 study, 305 participants; low-certainty evidence). None of the included studies reported on major adverse limb events (MALE) or above-ankle amputations. AUTHORS' CONCLUSIONS: Mobile health technologies can be used to provide lifestyle interventions for people with chronic conditions, such as IC. We identified a limited number of studies that met our inclusion criteria. We found no clear difference between mhealth and usual care in improving absolute walking distance in people with IC; however, we judged the evidence to be low certainty. Larger, well-designed RCTs are needed to provide adequate statistical power to reliably evaluate the effects of mhealth technologies on walking distance in people with IC.
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Claudicación Intermitente , Enfermedad Arterial Periférica , Adulto , Humanos , Claudicación Intermitente/tratamiento farmacológico , Enfermedad Arterial Periférica/complicaciones , Enfermedad Arterial Periférica/terapia , Terapia por Ejercicio/métodos , Caminata , Extremidad Inferior , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
AIM: Many challenges exist in determining true rates of adherence to antihypertensive medications among individuals in a clinic setting. For the first time, we aimed to compare patient-reported antihypertensive adherence with objective evidence using mass spectrometry spot urinalysis in a tertiary referral clinic setting. METHODS: A prospective observational single-centre cohort study was performed in a tertiary referral hypertension clinic, encompassing antihypertensive initiation and persistence. Patients were referred with apparent treatment-resistant hypertension or for suspected secondary causes. Participants completed a self-reported assessment of antihypertensive adherence and provided a spot urine sample. The presence of antihypertensive medications and/or their respective metabolites was evaluated using high-performance liquid chromatography tandem mass spectrometry. Patients were determined to be adherent if they demonstrated both self-reported adherence and objective mass spectrometry evidence. RESULTS: Of all 105 eligible participants initially recruited, 73 (69.5%) met the eligibility criteria. Only 27.4% (95% confidence interval 0.2-0.4) of participants demonstrated true adherence to their self-reported antihypertensives, despite 75.3% (0.6-0.8) reporting adherence. Greatest medication adherence was achieved with angiotensin II receptor blockers (61%), with calcium-channel blockers and mineralocorticoid antagonists demonstrating least adherence (38%). CONCLUSION: In patients attending a tertiary hypertension clinic, the combined use of spot urine mass spectrometry and self-reporting identifies higher rates of nonadherence when compared to either modality alone. Both techniques should be combined for more accurate detection of medication adherence.
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Antihipertensivos , Hipertensión , Humanos , Antihipertensivos/uso terapéutico , Estudios Prospectivos , Estudios de Cohortes , Hipertensión/diagnóstico , Hipertensión/tratamiento farmacológico , Cumplimiento de la Medicación , Espectrometría de Masas , Derivación y Consulta , Medición de Resultados Informados por el PacienteRESUMEN
BACKGROUND: Glycated albumin is of growing interest as an alternative biomarker of glycemia. However, the association of glycated albumin with long-term outcomes in the general population is uncharacterized. We evaluated the associations of glycated albumin and hemoglobin A1c (HbA1c) with mortality in US adults. METHODS: We conducted a prospective analysis of 12 915 participants in the National Health and Nutrition Examination Survey 1999-2004. We used Cox regression to characterize associations of glycated albumin and HbA1c with all-cause and cardiovascular mortality through 2014. We categorized glycated albumin based on percentiles corresponding to clinical cut-points for HbA1c. No diagnosed diabetes: <5.0% (<12th percentile), 5.0% to 5.6% (12th-82nd percentile, reference), 5.7% to 6.4% (83rd-97th percentile), and ≥6.5% (≥98th percentile). Diagnosed diabetes: <7.0% (<50th percentile), 7.0% to 8.9% (50th-83rd percentile), and ≥9.0% (≥84th percentile). RESULTS: Among US adults (mean age 46 years), the prevalence of diagnosed diabetes was 6.8%. Glycated albumin and HbA1c were highly correlated (r = 0.76). Over the median 16.8 years follow-up, there were 2818 deaths (652 cardiovascular). Adults with diagnosed diabetes and glycated albumin ≥84th percentile had the highest risk for all-cause mortality [hazard ratio (HR) 3.96, 95% CI 3.06-5.13] and cardiovascular mortality (HR 6.80, 95% CI 4.20-11.03). HbA1c had associations with all-cause and cardiovascular mortality that were similar to those for glycated albumin. CONCLUSIONS: Among US adults, increased values of glycated albumin and HbA1c were associated with all-cause and cardiovascular mortality, particularly in persons with diagnosed diabetes. Glycated albumin may be a useful alternative test of glycemia.
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Enfermedades Cardiovasculares , Diabetes Mellitus , Adulto , Glucemia , Enfermedades Cardiovasculares/epidemiología , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/epidemiología , Hemoglobina Glucada/análisis , Productos Finales de Glicación Avanzada , Humanos , Persona de Mediana Edad , Encuestas Nutricionales , Factores de Riesgo , Albúmina Sérica , Albúmina Sérica GlicadaRESUMEN
PURPOSE OF REVIEW: To describe the INTERASPIRE scientific protocol-an international survey of secondary prevention of coronary heart disease (CHD). RECENT FINDINGS: This international survey is being conducted through National Societies of Cardiology in selected countries from each of the six WHO regions and has the following overall aims: (i) describe prevalence of cardiometabolic and renal risk factors together with biomarkers in CHD patients; (ii) describe current risk factor management through lifestyle changes and cardioprotective drug therapies; (iii) provide an objective assessment of clinical implementation of preventive care by comparison with the lifestyle and risk factor targets defined in international and national guidelines; (iv) investigate the reasons for variation in preventive cardiology practice between regions and countries; and (v) promote the principles of best preventive cardiology practice. This international survey will provide a unique picture of CHD patients; their cardiometabolic, renal and biomarker status; lifestyle and therapeutic management; and the quality of preventive care provided in all WHO regions.
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Cardiología , Enfermedad Coronaria , Enfermedad Coronaria/prevención & control , Humanos , Factores de Riesgo , Encuestas y Cuestionarios , Organización Mundial de la SaludRESUMEN
AIMS: To evaluate 1,5-anhydroglucitol (1,5-AG) according to clinical outcomes and assess the effects of glucose- and blood pressure-lowering interventions on change in 1,5-AG levels in people with type 2 diabetes. METHODS: We measured 1,5-AG in 6826 stored samples at baseline and in a random subsample of 684 participants at the 1-year follow-up visit in the ADVANCE trial. We examined baseline 1,5-AG [< 39.7, 39.7-66.2, ≥ 66.2 µmol/L (<6, 6-10, ≥10 µg/mL)] and microvascular and macrovascular events and mortality using Cox regression models during 5 years of follow-up. Using an intention-to-treat approach, we examined 1-year change in 1,5-AG (mean and percent) in response to the glucose- and blood pressure-lowering interventions in the subsample. RESULTS: Low 1,5-AG level [<39.7 µmol/L vs ≥ 66.2 µmol/L (<6 µg/mL vs ≥10 µg/mL)] was associated with microvascular events (hazard ratio 1.28, 95% confidence interval 1.03-1.60) after adjustment for risk factors and baseline glycated haemoglobin (HbA1c); however, the associations for macrovascular events and mortality were not independent of HbA1c. The glucose-lowering intervention was associated with a significant 1-year increase in 1,5-AG (vs standard control) of 6.69 µmol/L (SE 2.52) [1.01 µg/mL (SE 0.38)], corresponding to an 8.26% (SE 0.10%) increase from baseline. We also observed an increase in 1,5-AG of similar magnitude in response to the blood pressure intervention independent of the glucose-lowering effect. CONCLUSIONS: Our results suggest that 1,5-AG is a marker of risk in adults with type 2 diabetes, but only for microvascular events independently of HbA1c. We found that 1,5-AG was improved (increased) in response to an intensive glucose-lowering intervention, although the independent effect of the blood pressure-lowering intervention on 1,5-AG suggests potential non-glycaemic influences.
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Antihipertensivos/administración & dosificación , Desoxiglucosa/sangre , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipertensión/tratamiento farmacológico , Hipoglucemiantes/administración & dosificación , Anciano , Glucemia/efectos de los fármacos , Diabetes Mellitus Tipo 2/complicaciones , Quimioterapia Combinada , Femenino , Gliclazida/administración & dosificación , Hemoglobina Glucada/efectos de los fármacos , Humanos , Hipertensión/complicaciones , Indapamida/administración & dosificación , Análisis de Intención de Tratar , Masculino , Microvasos/efectos de los fármacos , Persona de Mediana Edad , Perindopril/administración & dosificación , Modelos de Riesgos Proporcionales , Factores de Riesgo , Resultado del TratamientoRESUMEN
When the consultation is predominantly verbal, existing research in clinician-patient communication indicates that many patients struggle to understand and recall medical consultations or may not understand the extent of their illness or the purpose of their treatment plan. When the clinician-patient discussion centers around the risk of a repeated cardiovascular disease (CVD) related event, qualitatively assessing what factors affect the communication of this risk may guide the creation of effective communication solutions. Semi-structured interviews were conducted with 17 clinicians treating patients at stages along the cardiac rehabilitation patients' journey. Thematic analysis identified factors that prevent patients from understanding the risk they face of experiencing a repeated cardiac event. Results indicate a clearer understanding of the cardiac rehabilitation patient journey by means of a patient journey map; an overview of how CVD risk is currently communicated; and the factors that affect communication of these risks in the form of themes and sub-themes. Findings shape the proposal of an evidence informed model of opportunities for enhanced digital media supported communication in cardiac rehabilitation.
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OBJECTIVES: A knowledge gap exists around the costs and budget impact of specialist hypertension clinics. This study reports on the cost of providing care in a multidisciplinary hypertension clinic staffed by nephrologist, endocrinologist and cardiologist, which manages patients with suspected secondary hypertension and/or apparent treatment-resistant hypertension. The aim of this study is to provide the evidence required to inform policy and planning care pathways for this patient group. METHODS: A cost analysis from a healthcare provider perspective using micro-costing techniques was conducted to estimate the direct implementation costs of existing standard practice for the care pathway of patients attending the multidisciplinary hypertension clinic. Sixty-five patients originally recruited for a study of medication adherence in hypertension were included in the sample. RESULTS: The total care-pathway cost per patient, taking into account clinic visits, clinical reviews, investigations and MDT discussion, was estimated to be 3277, on average. For the patient subgroups, the average cost was 5644 for patients diagnosed with primary aldosteronism and 1446 for patients diagnosed with essential hypertension. CONCLUSION: There is significant cost associated with providing specialized hypertension care for patients with apparent treatment-resistant hypertension. Given the high rates of nonadherence in this population, it is likely that some of this cost could be avoided with better detection and management of medication adherence in this challenging population. Future studies should consider the cost-effectiveness of this or similar models of care by exploring the benefit to patients and the wider healthcare context of providing care of this type.
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Hipertensión , Humanos , Costos y Análisis de Costo , Hipertensión/tratamiento farmacológico , Atención Ambulatoria , Cumplimiento de la MedicaciónRESUMEN
BACKGROUND AND AIMS: Aspirin is considered mandatory after myocardial infarction (MI). However, its long-term efficacy has been questioned. This study investigated the effectiveness of long-term aspirin after MI. METHODS: Patients ≥ 40 years with MI from 2004-2017 who were adherent to aspirin one year after MI were included from Danish nationwide registries. At 2, 4, 6, and 8 years after MI, continued adherence to aspirin was evaluated. Absolute and relative risks of MI, stroke, or death at 2 years from each timepoint were calculated using multivariable logistic regression analysis with average treatment effect modeling standardized for age, sex, and comorbidities. Subgroup analyses were stratified by sex and age > and ≤ 65 years. RESULTS: Among 40 114 individuals included, the risk of the composite endpoint was significantly higher for nonadherent patients at all timepoints. The absolute risk was highest at 2-4 years after MI for both adherent (8.34%, 95% confidence interval [CI]: 8.05-8.64%) and nonadherent patients (10.72%, 95% CI: 9.78-11.66%). The relative risk associated with nonadherence decreased from 4 years after index-MI and onwards: 1.41 (95% CI: 1.27-1.55) at 4-6 years and 1.21 (95% CI: 1.06-1.36) at 8-10 years (Ptrend = 0.056). Aspirin nonadherence in women and individuals > 65 years was not associated with increased risk. Pinteraction at each of the timepoints: Age-<0.001, <0.001, 0.002, 0.51; Sex - 0.25, 0.02, 0.02, 0.82. CONCLUSION: Nonadherence to long-term aspirin was associated with increased risk of MI, stroke, or death, but not in women or individuals > 65 years. The risk decreased from 4 years after MI with near statistical significance.
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BACKGROUND: There are different definitions of periprocedural myocardial infarction (PPMI) both in terms of thresholds for cardiac biomarkers and the ancillary criteria for myocardial ischemia. Cardiac Troponin I (cTnI) and cardiac Troponin T (cTnT) are used interchangeably to diagnose PPMI. OBJECTIVES: This study evaluated the frequency of periprocedural myocardial injury and infarction as defined by the Society of Cardiovascular Angiography & Interventions (SCAI), the Academic Research Consortium-2 (ARC-2), and the 4th Universal definition of MI (4UDMI) stratified using cTnT versus cTnI, among patients with chronic coronary syndrome (CCS) and unstable angina. RESULTS: Among 830 patients, PPMI rates according to the SCAI, ARC2 and 4UDMI criteria were 4.34 %, 2.05 %, and 4.94 % respectively, with higher rates seen for all definitions when using cTnI versus cTnT (SCAI: 9.84 % vs. 1.91 %, p < 0.001; ARC 2: 3.15 % vs. 1.56 %, p = 0.136; and 4UDMI 5.91 % vs. 4.51 %, p = 0.391). Minor and major periprocedural myocardial injury was respectively observed in 58.31 % and 27.10 % of patients, with rates of both significantly higher when using cTnI versus cTnT (Minor: 69.29 % vs. 53.47 %, p < 0.001, Major: 49.21 % vs. 17.36 %, p < 0.001). CONCLUSIONS: Among patients with CCS and unstable angina, PPMIs defined by SCAI occurred more frequently when using cTnI as opposed to cTnT, whereas the type of troponin had no impact on the incidence of PPMIs according to the ARC-2 and 4UDMI.
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Pollution is a leading cause of premature morbidity and mortality and an important risk factor for cardiovascular disease. Convincing data predict increased rates of cardiovascular morbidity and mortality with current and projected pollution burden trends. Multiple classes of pollutants - including criteria air pollutants, secondhand smoke, toxic steel pollutants, and manufactured chemical pollutants - are associated with varied cardiovascular disease risk profiles. To reduce the future risk of cardiovascular disease from anthropogenic pollution, mitigation strategies, both at the individual level and population level, must be thoughtfully and intentionally employed. The literature supporting individual level interventions to protect against cardiovascular disease is growing but lacks large clinical trials. Population level interventions are crucial to larger societal change and rely upon policy and governmental support. While these mitigation strategies can play a major role in maintaining the health of individuals, planetary health - the impact on human health because of anthropogenic perturbation of natural ecosystems - must also be acknowledged. Future research is needed to further delineate the planetary health implications of current and projected pollutant burden as well as the mitigation strategies employed to attenuate future pollutant burden.
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BACKGROUND: The COVID-19 pandemic accelerated the uptake of digital health interventions for the delivery of cardiac rehabilitation (CR). However, there is a need to evaluate these interventions. METHODS: We examined the impact of an evidence-based, digital CR programme on medical, lifestyle and psychosocial outcomes. Delivered by an interdisciplinary team of healthcare professionals, the core components of this 12-week programme included lifestyle modification, medical risk factor management, psychosocial and behavioural change support. To support self-management, patients were provided with a Fitbit, a home blood pressure (BP) monitor and an interactive workbook. Patients received access to a bespoke web-based platform and were invited to attend weekly, online group-based supervised exercise sessions and educational workshops. Outcomes were assessed at baseline, end of programme and at 6-month follow-up. RESULTS: Over a 3-month period, 105 patients (88% with coronary heart disease) were referred with 74% (n=77) attending initial assessment. Of these, 97% (n=75) enrolled in the programme, with 85% (n=64) completing the programme, 86% (n=55) of completers attended 6-month follow-up. Comparing baseline to end of programme, we observed significant improvements in the proportion of patients meeting guideline-recommended targets for physical activity (+68%, p<0.001), BP (+44%, p<0.001) and low-density lipoprotein cholesterol (+27%, p<0.001). There were significant reductions in mean weight (-2.6 kg, p<0.001). Adherence to the Mediterranean diet score improved from 5.2 to 7.3 (p<0.001). Anxiety and depression levels (Hospital Anxiety and Depression score) both reduced by more than 50% (p<0.001). The majority of these improvements were sustained at 6-month follow-up. CONCLUSION: Outcomes from this study suggest that interdisciplinary digital CR programmes can be successfully implemented and help patients achieve guideline recommended lifestyle, medical and therapeutic targets.
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COVID-19 , Rehabilitación Cardiaca , Humanos , Pandemias , Factores de Riesgo , Ejercicio FísicoRESUMEN
AIMS: Aspirin therapy for primary prevention of cardiovascular disease (CVD) is controversial, and guideline recommendations have changed throughout the last decades. We report temporal trends in primary prevention aspirin use among persons with and without diabetes and describe characteristics of incident aspirin users. METHODS AND RESULTS: Using Danish nationwide registries, we identified incident and prevalent aspirin users in a population of subjects ≥40 years without CVD eligible for primary preventive aspirin therapy from 2000 through 2020. Temporal trends in aspirin users with and without diabetes were assessed, as were CVD risk factors among incident users. A total of 522 680 individuals started aspirin therapy during the study period. The number of incident users peaked in 2002 (39 803 individuals, 1.78% of the eligible population) and was the lowest in 2019 (11 898 individuals, 0.49%), with similar trends for subjects with and without diabetes. The percentage of incident users with no CVD risk factors [diabetes, hypertension, hypercholesterolemia, or chronic obstructive pulmonary disease (a proxy for smoking)] decreased from 53.9% in 2000 to 30.9% in 2020. The temporal trends in prevalent aspirin users followed a unimodal curve, peaked at 7.7% in 2008, and was 3.3% in 2020. For subjects with diabetes, the peak was observed in 2009 at 38.5% decreasing to 17.1% in 2020. CONCLUSION: Aspirin therapy for primary prevention of CVD has decreased over the last two decades. However, the drug remained used in individuals with and without diabetes, and a large proportion of individuals started on aspirin therapy had no CVD risk factors.
One sentence summaryThis study investigated the temporal trends in aspirin use for primary prevention of cardiovascular disease in individuals with and without diabetes and found that even though the number of aspirin users has declined, the drug remains prescribed, and individuals even without cardiovascular risk factors were started on aspirin therapy. Lay summary key findingsThe number of aspirin users with and without diabetes for primary prevention of cardiovascular disease has decreased over the last two decades. Nevertheless, individuals with a low burden of cardiovascular risk factors were started on aspirin therapy.Efforts to inform appropriate use of aspirin are needed.
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Aspirina , Enfermedades Cardiovasculares , Diabetes Mellitus , Prevención Primaria , Adulto , Humanos , Aspirina/uso terapéutico , Enfermedades Cardiovasculares/prevención & control , Diabetes Mellitus/epidemiología , Europa (Continente)/epidemiología , Prevención Primaria/tendencias , Masculino , Femenino , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Guías de Práctica Clínica como Asunto , Factores de Riesgo de Enfermedad CardiacaRESUMEN
Background We characterized the burden and prognostic value of subclinical cardiovascular disease (CVD) assessed by cardiac biomarkers among adults with and without diabetes in the general US population. Methods and Results We measured hs-cTnT (high-sensitivity cardiac troponin T) and NT-proBNP (N-terminal pro-B-type natriuretic peptide) in stored serum samples from the 1999 to 2004 National Health and Nutrition Examination Survey. Among US adults without a history of CVD (n=10 304), we estimated the prevalence of elevated hs-cTnT (≥14 ng/L) and NT-proBNP (≥125 pg/mL) in those with and without diabetes. We examined the associations between elevated hs-cTnT and NT-proBNP with all-cause and CVD mortality after adjustment for demographics and traditional CVD risk factors. The crude prevalence of subclinical CVD (elevated hs-cTnT or NT-proBNP) was ≈2 times higher in adults with (versus without) diabetes (33.4% versus 16.1%). After age adjustment, elevated hs-cTnT, but not elevated NT-proBNP, was more common in those with diabetes, overall and across age, sex, race and ethnicity, and weight status. The prevalence of elevated hs-cTnT was significantly higher in those with longer diabetes duration and worse glycemic control. In persons with diabetes, elevated hs-cTnT and NT-proBNP were independently associated with all-cause mortality (adjusted hazard ratio [HR], 1.77 [95% CI, 1.33-2.34] and HR, 1.78 [95% CI, 1.26-2.51]) and CVD mortality (adjusted HR, 1.54 [95% CI, 0.83-2.85] and HR, 2.46 [95% CI, 1.31-4.60]). Conclusions Subclinical CVD affects ≈1 in 3 US adults with diabetes and confers substantial risk for mortality. Routine testing of cardiac biomarkers may be useful for assessing and monitoring risk in persons with diabetes.
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Enfermedades Cardiovasculares , Diabetes Mellitus , Humanos , Adulto , Enfermedades Cardiovasculares/diagnóstico , Enfermedades Cardiovasculares/epidemiología , Encuestas Nutricionales , Biomarcadores , Diabetes Mellitus/epidemiología , Pronóstico , Fragmentos de Péptidos , Péptido Natriurético Encefálico , Troponina T , Factores de RiesgoRESUMEN
Background: Digital health interventions (DHIs) are increasingly used for the secondary prevention of cardiovascular disease (CVD). The aim of this study is to determine the feasibility of "INTERCEPT", a co-designed DHI developed to improve secondary prevention in hospitalised coronary heart disease patients (CHD). Methods: This non-randomised feasibility study will be conducted using a mixed methods process evaluation with a sample of 40 patients in an acute hospital setting. Informed by behaviour change theory, the Intercept application (I-App) integrates a smartphone interface, health care professional portal, a fitness wearable and a blood pressure monitor. I-App is designed to support and motivate patients to set goals, self-monitor lifestyle and medical risk factors, and manage their medications, with the health care professional portal enabling monitoring and communication with patients. Using convenience sampling, eligible patients will be recruited in two phases, a pre-implementation phase and an implementation phase. During the pre-implementation phase participants will not immediately receive the I-App but will be invited to receive the I-App at 3 months follow-up. This will enable early learning about the processes of recruitment and conducting the assessment prior to full scale deployment of the I-App. During the implementation phase, participants will be invited to download the I-App to their smartphone prior to hospital discharge. Qualitative interviews will be conducted among a subset of patients and health care professionals to gain a greater insight into their experience of using the I-App. Primary outcomes will be assessed at baseline and 3-month follow-up. Using pre-defined feasibility criteria, including recruitment, retention and engagement rates, together with data on intervention acceptability, will determine the appropriateness of progressing to a definitive trial. Discussion: This study will provide important insights to help inform the feasibility of conducting a definitive trial of "INTERCEPT" among coronary heart disease patients in a critical health care setting.
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Background: The presence and interpretation of racial and ethnic differences in circulating N-terminal pro-brain-type natriuretic peptide (NT-proBNP), a diagnostic biomarker for heart failure, are controversial. Objective: To examine racial and ethnic differences in NT-proBNP levels among the general US adult population. Methods: We performed a cross-sectional analysis of data from the 1999-2004 National Health and Nutrition Examination Survey (NHANES). We included 4717 non-Hispanic White, 1675 non-Hispanic Black, and 2148 Mexican American adults aged 20 years or older without a history of cardiovascular disease. We examined the associations of race and ethnicity with NT-proBNP using linear and logistic regression models in the overall population and in a younger, 'healthy' subsample. Results: The mean age was 45 years. Median NT-proBNP levels were significantly lower among Black (29.3 pg/mL) and Mexican American adults (28.3.4 pg/mL) compared to White adults (49.1pg/mL, P-values<0.001). After adjusting for sociodemographic factors and cardiovascular risk factors, NT-proBNP was 34.4% lower (95%CI -39.2 to -29.3%) in Black adults and 22.8% lower (95%CI -29.4 to -15.5) in Mexican American adults compared to White adults. Our findings were consistent in a young, healthy subsample, suggesting non-cardiometabolic determinants of these differences. Conclusions: NT-proBNP levels are significantly lower among Black and Mexican American adults compared with White adults, independent of cardiometabolic risk. Although race/ethnicity is a poor proxy for genetic differences, our findings may have clinical implications for the management of HF. However, studies in diverse populations are needed to characterize the biological basis of NT-proBNP variation.
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BACKGROUND: N-terminal pro-B-type natriuretic peptide (NT-proBNP) is a cardiac biomarker used in the clinical management of heart failure. We sought to create updated reference intervals for NT-proBNP for healthy US children, adolescents, and adults. METHODS: We identified a population of healthy individuals using the 1999 to 2004 cycles of the National Health and Nutrition Examination Survey (NHANES). We measured serum NT-proBNP in 12 346 adults and 15 752 children and adolescents with the Elecsys NT-proBNP assay on the Roche e601 autoanalyzer. We compared 4 methods for reference interval calculation, and presented the final reference intervals using the robust method partitioned by age and sex categories. RESULTS: NT-proBNP values were available for 1949 healthy adults and 5250 healthy children and adolescents. NT-proBNP concentrations in males and females varied according to age, being higher in early childhood, relatively lower in late adolescence, and highest through middle age and older age. Females tended to have higher NT-proBNP concentrations compared to men from late adolescence until middle age. The upper reference limit, or 97.5th percentile, for 50 to 59 year-old men was 225 ng/L (90% CI: 158 to 236), and for 50 to 59 year-old women, 292 ng/L (90% CI: 242 to 348). CONCLUSIONS: Among healthy individuals, NT-proBNP concentrations varied greatly according age and sex. The reference intervals presented here should inform future clinical decision limits and suggest that age- and sex-specific intervals may be necessary to more precisely characterize risk.
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Péptido Natriurético Encefálico , Fragmentos de Péptidos , Masculino , Persona de Mediana Edad , Humanos , Adulto , Niño , Preescolar , Femenino , Adolescente , Encuestas Nutricionales , Valores de ReferenciaRESUMEN
Background: Hypertension is one of the most important risk factors for stroke and heart disease. Recent international guidelines have stated that 'poor adherence to treatment - in addition to physician inertia - is the most important cause of poor blood pressure control'. The MaxImising Adherence, Minimising Inertia (MIAMI) intervention, which has been developed using a systematic, theoretical, user-centred approach, aims to support general practitioners (GPs) and people with hypertension to maximise medication use, through the facilitation of adequate information exchange within consultations about long-term antihypertensive medication use and adherence skill development. The aim of the MIAMI pilot cluster randomised controlled trial (RCT) is to gather and analyse feasibility data to allow us to (1) refine the intervention, and (2) determine the feasibility of a definitive RCT. Methods: GP practices (n = 6) will be recruited and randomised to the intervention arm (n = 3) or usual care control arm (n = 3). Each practice will recruit 10 patient participants. For a patient to be eligible they must have a diagnosis of hypertension, be on two or more anti-hypertensive medications, must not be achieving recommended blood pressure levels, and be over the age of 65 years. Participants in the intervention arm will meet their GP and receive the MIAMI intervention twice over three months. Quantitative data collection will take place at baseline and three month follow up. A pilot health economic analysis and a qualitative sub-study will also be incorporated into the study. Discussion: This pilot cluster RCT of the MIAMI intervention will allow us to gather valuable acceptability and feasibility data to further refine the intervention so it optimally designed for both GP and patient use. In particular, the qualitative component will provide an insight into GP and patient experiences of using the intervention.
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AIMS: The 2021 European Society of Cardiology cardiovascular disease (CVD) prevention guidelines recommend the use of (lifetime) risk prediction models to aid decisions regarding intensified preventive treatment options in adults with Type 2 diabetes, e.g. the DIAbetes Lifetime perspective model (DIAL model). The aim of this study was to update the DIAL model using contemporary and representative registry data (DIAL2) and to systematically calibrate the model for use in other European countries. METHODS AND RESULTS: The DIAL2 model was derived in 467 856 people with Type 2 diabetes without a history of CVD from the Swedish National Diabetes Register, with a median follow-up of 7.3 years (interquartile range: 4.0-10.6 years) and comprising 63 824 CVD (including fatal CVD, non-fatal stroke and non-fatal myocardial infarction) events and 66 048 non-CVD mortality events. The model was systematically recalibrated to Europe's low- and moderate-risk regions using contemporary incidence data and mean risk factor distributions. The recalibrated DIAL2 model was externally validated in 218 267 individuals with Type 2 diabetes from the Scottish Care Information-Diabetes (SCID) and Clinical Practice Research Datalink (CPRD). In these individuals, 43 074 CVD events and 27 115 non-CVD fatal events were observed. The DIAL2 model discriminated well, with C-indices of 0.732 [95% confidence interval (CI) 0.726-0.739] in CPRD and 0.700 (95% CI 0.691-0.709) in SCID. CONCLUSION: The recalibrated DIAL2 model provides a useful tool for the prediction of CVD-free life expectancy and lifetime CVD risk for people with Type 2 diabetes without previous CVD in the European low- and moderate-risk regions. These long-term individualized measures of CVD risk are well suited for shared decision-making in clinical practice as recommended by the 2021 CVD ESC prevention guidelines.