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1.
Clin Chem ; 66(3): 434-444, 2020 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-32109298

RESUMO

BACKGROUND: How to select healthy reference subjects in deriving 99th percentiles for cardiac troponin assays still needs to be clarified. To assist with global implementation of high sensitivity (hs)-cardiac troponin (cTn) I and hs-cTnT assays in clinical practice, we determined overall and sex-specific 99th percentiles in 9 hs-cTnI and 3 hs-cTnT assays using a universal sample bank (USB). METHODS: The Universal Sample Bank (USB) comprised healthy subjects, 426 men and 417 women, screened using a health questionnaire. Hemoglobin A1c (>URL 6.5%), NT-proBNP (>URL 125 ng/L) and eGFR (<60 mL/min), were used as surrogate biomarker exclusion criteria along with statin use. 99th percentiles were determined by nonparametric, Harrell--Davis bootstrap, and robust methods. RESULTS: Subjects were ages 19 to 91 years, Caucasian 58%, African American 27%, Pacific Islander/Asian 11%, other 4%, Hispanic 8%, and non-Hispanic 92%. The overall and sex-specific 99th percentiles for all assays, before and after exclusions (n = 694), were influenced by the statistical method used, with substantial differences noted between and within both hs-cTnI and hs-cTnT assays. Men had higher 99th percentiles (ng/L) than women. The Roche cTnT and Beckman and Abbott cTnI assays (after exclusions) did not measure cTn values at ≥ the limit of detection in ≥50% women. CONCLUSIONS: Our findings have important clinical implications in that sex-specific 99th percentiles varied according to the statistical method and hs-cTn assay used, not all assays provided a high enough percentage of measurable concentrations in women to qualify as a hs-assay, and the surrogate exclusion criteria used to define normality tended to lower the 99th percentiles.

3.
Ann Emerg Med ; 2020 Feb 08.
Artigo em Inglês | MEDLINE | ID: mdl-32046869

RESUMO

STUDY OBJECTIVE: We determine the accuracy of high-sensitivity cardiac troponin I (hs-cTnI), European-derived, rapid, acute myocardial infarction, rule-out/rule-in algorithms applied to a US emergency department (ED) population. METHODS: Adults presenting to the ED with suspected acute myocardial infarction were included. Plasma samples collected at baseline and between 40 and 90 minutes and 2 and 3 hours later were analyzed in core laboratories using the Siemens Healthineers hs-cTnI assays. Acute myocardial infarction diagnosis was independently adjudicated. The sensitivity, specificity, and negative and positive predictive values for rapid acute myocardial infarction rule-out/rule-in using European algorithms and 30-day outcomes are reported. RESULTS: From 29 US medical centers, 2,113 subjects had complete data for the 0/1-hour algorithm analyses. With the Siemens Atellica Immunoassay hs-cTnI values, 1,065 patients (50.4%) were ruled out, with a negative predictive value of 99.7% and sensitivity of 98.7% (95% confidence interval 99.2% to 99.9% and 96.3% to 99.6%, respectively), whereas 265 patients (12.6%) were ruled in, having a positive predictive value of 69.4% and specificity of 95.7% (95% confidence interval 63.6% to 74.7% and 94.7% to 96.5%, respectively). The remaining 783 patients (37.1%) were classified as having continued evaluations, with an acute myocardial infarction incidence of 5.6% (95% confidence interval 4.2% to 7.5%). The overall 30-day risk of death or postdischarge acute myocardial infarction was very low in the ruled-out patients but was incrementally increased in the other groups (rule-out 0.2%; continued evaluations 2.1%; rule-in 4.8%). Equivalent results were observed in the 0/2- to 3-hour analyses and when both algorithms were applied to the hs-cTnI ADVIA Centaur measurements. CONCLUSION: The European rapid rule-out/rule-in acute myocardial infarction algorithm hs-cTnI cut points can be harmonized with a demographically and risk-factor diverse US ED population.

4.
Int J Cardiol ; 299: 282-288, 2020 01 15.
Artigo em Inglês | MEDLINE | ID: mdl-31447226

RESUMO

BACKGROUND: Despite diet being a first-line strategy for preventing cardiovascular disease, the optimal macronutrient profile remains unclear. We studied the effects of macronutrient profile on subclinical cardiovascular injury and inflammation. METHODS: OmniHeart was a randomized 3-period, crossover feeding study in 164 adults with high blood pressure or hypertension (SBP 120-159 or DBP 80-99 mm Hg). Participants were fed each of 3 diets (emphasizing carbohydrate (CARB), protein (PROT), or unsaturated fat (UNSAT)) for 6-weeks, with feeding periods separated by a washout period. Weight was held constant. Fasting serum was collected at baseline while participants ate their own diets and after each feeding period. High-sensitivity cardiac troponin I (hs-cTnI) and high-sensitivity C-reactive protein (hs-CRP) were measured in stored specimens. RESULTS: The average age was 53.6 years, 55% were African American, and 45% were women. At baseline, the median (25th-percentile, 75th-percentile) hs-cTnI was 3.3 ng/L (1.9, 5.6) and hs-CRP was 2.2 mg/L (1.1, 5.2). Compared to baseline, all 3 diets reduced hs-cTnI: CARB -8.6% (95%CI: -16.1, -0.4), PROT -10.8% (-18.4, -2.5), and UNSAT -9.4% (-17.4, -0.5). Hs-CRP was similarly changed by -13.9 to -17.0%. Hs-cTnI and hs-CRP reductions were of similar magnitudes as SBP and low-density lipoprotein cholesterol (LDLc) but were not associated with these risk-factor reductions (P-values = 0.09). There were no between-diet differences in hs-cTnI and hs-CRP reductions. CONCLUSIONS: Healthy diet, regardless of macronutrient emphasis, directly mitigated subclinical cardiac injury and inflammation in a population at risk for cardiovascular disease. These findings support dietary recommendations emphasizing healthy foods rather than any one macronutrient. TRIAL REGISTRATION: This trial is registered at clinicaltrials.gov, number: NCT00051350; URL: https://clinicaltrials.gov/ct2/show/NCT00051350.

5.
Clin Biochem ; 2019 Oct 26.
Artigo em Inglês | MEDLINE | ID: mdl-31669511

RESUMO

BACKGROUND: Cardiac troponin (cTn) is the keystone for diagnosis of acute myocardial infarction (AMI). We examined the analytical and diagnostic accuracy of the Atellica IM TnIH assay to determine high-sensitivity performance and appropriate diagnostic performance for clinical use. METHODS: Sex-specific 99th percentile upper reference limits (URLs) were determined for a healthy cohort of 1007 women and 1000 men using non-parametric statistics. High-sensitivity performance was assessed by examining if imprecision was ≤10% at sex-specific URLs and if ≥50% of cTnI values for each sex exceeded the assay's limit of detection (LoD) with the AACC Universal Sample Bank. Precision, high-dose hook effect, endogenous/exogenous interferences were examined with CLSI guidance. Clinical characterization was with 2494 suspected AMI subjects presenting to emergency departments across the United States. AMI was adjudicated by expert cardiologists and emergency medicine physicians. There were no comorbidity exclusions. RESULTS: 99th percentile URLs were 34 ng/L, 53 ng/L and 45 ng/L for the female, male and overall populations, respectively. Total imprecision was <5% from 12 ng/L to 16,000 ng/L; ≥55% of cTnI values for each sex exceeded the LoD. No high-dose hook or endogenous/exogenous interferences were identified. After 2.5-3.5 h post presentation the sensitivity and specificity were >90%; negative and positive predictive value were ≥98% and >60%, respectively. Non-AMI subjects with comorbidities and values exceeding 99th percentile URLs had absolute and percent change at 2-4 h that were lower than AMI patients with comorbidities (p = 0.001). CONCLUSION: The Atellica IM TnIH assay is a high-sensitivity method and demonstrates clinical performance appropriate for AMI diagnosis.

6.
J Am Coll Cardiol ; 74(3): 271-282, 2019 Jul 23.
Artigo em Inglês | MEDLINE | ID: mdl-31319909

RESUMO

BACKGROUND: Limited data exist on rapid risk-stratification strategies using the U.S. Food and Drug Administration-cleared high-sensitivity cardiac troponin I (hs-cTnI) assays. OBJECTIVES: This study sought to examine single measurement hs-cTnI to identify patients at low and high risk for acute myocardial infarction (MI). METHODS: This was a prospective, multicenter, observational study of patients with suspected acute MI enrolled across 29 U.S. sites with hs-cTnI measured using the Atellica IM TnIH and ADVIA Centaur TNIH (Siemens Healthineers) assays. To identify low-risk patients, sensitivities and negative predictive values (NPVs) for acute MI and MI or death at 30 days were examined across baseline hs-cTnI concentrations. To identify high-risk patients, positive predictive values and specificities for acute MI were evaluated. RESULTS: Among 2,212 patients, acute MI occurred in 12%. The limits of detection or quantitation resulted in excellent sensitivities (range 98.6% to 99.6%) and NPVs (range 99.5% to 99.8%) for acute MI or death at 30 days across both assays. An optimized threshold of <5 ng/l identified almost one-half of all patients as low risk, with sensitivities of 98.6% (95% confidence interval: 97.2% to 100%) and NPVs of 99.6% (95% confidence interval: 99.2% to 99.9%) for acute MI or death at 30 days across both assays. For high-risk patients, hs-cTnI ≥120 ng/l resulted in positive predictive values for acute MI of ≥70%. CONCLUSIONS: Recognizing the continuous relationship between baseline hs-cTnI and risk for adverse events, using 2 Food and Drug Administration-cleared hs-cTnI assays, an optimized threshold of <5 ng/l safely identified almost one-half of all patients as low risk at presentation, with hs-cTnI ≥120 ng/l identifying high-risk patients.

7.
Clin Biochem ; 72: 30-38, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31129184

RESUMO

BACKGROUND: Total tau (tTau) and phosphorylated 181P tau (pTau) are supportive diagnostic cerebrospinal fluid (CSF) biomarkers for Alzheimer's disease. Manual CSF tau assays are limited by lot-to-lot and between-laboratory variability and long incubation/turnaround times. Elecsys® Total-Tau CSF and Phospho-Tau (181P) CSF immunoassays were developed for fully automated cobas e analyzers, allowing broader access in clinical practice and trials. METHODS: Analytical performance, reproducibility, method comparisons with commercially available assays, and lot-to-lot and platform comparability (cobas e 601/411) of the Elecsys® CSF assays were assessed. Tau distributions and concentration ranges were evaluated in CSF samples from two clinical cohorts. RESULTS: Both assays showed high sensitivity (limit of quantitation [LoQ]: 63 pg/mL [tTau]; 4 pg/mL [pTau]) and linearity over the measuring range (80-1300 pg/mL; 8-120 pg/mL), which covered the entire concentration range measured in clinical samples. Lot-to-lot and platform comparability demonstrated good consistency (Pearson's r: 0.998; 1.000). Multicenter evaluation coefficients of variation (CVs): repeatability, < 1.8%; intermediate precision, < 2.8%; between-laboratory variability, < 2.7% (both assays); and total reproducibility, < 6.7% (tTau) and < 4.7% (pTau). Elecsys® CSF assays demonstrated good correlation with commercially available tau assays. CONCLUSIONS: Elecsys® Total-Tau CSF and Phospho-Tau (181P) CSF assays demonstrate good analytical performance with clinically relevant measuring ranges; data support their use in clinical trials and practice.


Assuntos
Imunoensaio/métodos , Proteínas tau/líquido cefalorraquidiano , Doença de Alzheimer/líquido cefalorraquidiano , Doença de Alzheimer/diagnóstico , Biomarcadores/líquido cefalorraquidiano , Biomarcadores/química , Humanos , Limite de Detecção , Fosforilação , Reprodutibilidade dos Testes , Proteínas tau/química
8.
Clin Chim Acta ; 495: 481-486, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31125533

RESUMO

Genomics-driven precision medicine using targeted therapies requires advanced molecular diagnostic tests. Decisions about the use and reimbursement for such tests are increasingly being made on the basis of more outcome-based and value-based approaches. The value proposition concept is a tool to assess the benefits of laboratory testing to each stakeholder of the care pathway with respect to outcomes. This concept was applied to the use of noninvasive plasma epidermal growth factor receptor (EGFR) mutation testing in patients with advanced or metastatic non-small cell lung cancer (NSCLC) to guide treatment with EGFR tyrosine kinase inhibitors (TKIs). Using the value proposition framework, we evaluated published key evidence regarding clinical validity, economic implications, and limitations of this approach. It has been shown that plasma EGFR mutation testing is essential for guiding clinical decisions regarding prediction of eligibility of individual patients for TKI treatment, real-time monitoring, or adjustment of treatment regimens and tracking resistance. The appropriate use of plasma EGFR mutation testing has been shown to deliver both clinical and economic benefits to stakeholders across the entire care pathway; especially in clinical situations where biopsy material is inadequate or unavailable and where it leads to fewer tissue biopsies.


Assuntos
Carcinoma Pulmonar de Células não Pequenas/sangue , Carcinoma Pulmonar de Células não Pequenas/genética , Análise Mutacional de DNA , Receptores ErbB/sangue , Receptores ErbB/genética , Neoplasias Pulmonares/sangue , Neoplasias Pulmonares/genética , Humanos , Medicina de Precisão
9.
J Am Coll Cardiol ; 73(9): 1059-1077, 2019 03 12.
Artigo em Inglês | MEDLINE | ID: mdl-30798981

RESUMO

High-sensitivity cardiac troponin (hs-cTn) I or T methods have been in use in certain regions for years but are now increasingly globally adopted, including in the United States. Accordingly, inevitable challenges are created for institutions transitioning from conventional cardiac troponin (cTn) assays. hs-cTn assays have higher analytic precision at lower concentrations, yielding greater clinical sensitivity for myocardial injury and allowing accurate recognition of small changes in troponin concentration (rise or fall) within a short time frame. Although much of the knowledge regarding troponin biology that was applicable with older troponin assays still holds true, considerable education regarding the differences between conventional cTn and hs-cTn is needed before medical systems convert to the newer methods. This includes a basic understanding of how hs-cTn testing differs from conventional cTn testing and how it is best deployed in different settings, such as the emergency department and inpatient services. This Expert Panel will review important concepts for institutional transition to hs-cTn methodology, providing recommendations useful for education before implementation.


Assuntos
Tomada de Decisão Clínica/métodos , Serviço Hospitalar de Emergência , Infarto do Miocárdio/sangue , Guias de Prática Clínica como Assunto , Troponina/sangue , Biomarcadores/sangue , Humanos , Infarto do Miocárdio/diagnóstico
10.
Hemodial Int ; 23(1): 58-68, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30724445

RESUMO

INTRODUCTION: Patients with end-stage renal disease (ESRD) have reduced endothelial function, but whether macro- and microvascular endothelial function correlate with baseline risk factors and cardiovascular outcomes in this population is not well understood. METHODS: Among 146 participants of the Cardiac, Endothelial Function and Arterial Stiffness in ESRD (CERES) study, we evaluated macro- and microvascular endothelial dysfunction as flow-mediated dilation (FMD) and velocity time integral (VTI), respectively. We examined cross-sectional correlations of baseline characteristics, inflammatory and cardiac markers with FMD and VTI. We followed participants for the composite outcome of cardiovascular hospitalization or all-cause death over fourteen months. Cox survival analyses were adjusted for demographics, comorbidities, medications, systolic blood pressure, inflammation, high-sensitivity troponin T (hs-TnT), and N-terminal pro B-type natriuretic peptide (NT-proBNP). FINDINGS: Impaired VTI was associated with older age and Black race (P < 0.05), as well as female gender, atherosclerosis, and hemodialysis (as opposed to peritoneal dialysis) (P < 0.2). Myocardial injury, measured as hs-TnT, inflammatory markers and NT-proBNP correlated with impaired VTI. In unadjusted analyses, VTI was significantly associated with the composite outcome (HR per SD VTI 0.65 [95%CI 0.45, 0.95]), but FMD was not (HR per SD FMD 0.97 [95%CI 0.69, 1.4]). When VTI was calculated as the ratio of (hyperemic VTI-baseline VTI)/baseline VTI, its association with the outcome persisted after multivariable adjustment. DISCUSSION: Microvascular function was associated with higher rates of cardiovascular hospitalizations and all-cause mortality among individuals with ESRD on dialysis. Further research is needed to learn whether novel therapies that target microvascular endothelial function could improve outcomes in this high-risk population.

11.
Crit Pathw Cardiol ; 18(1): 10-15, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30747759

RESUMO

The TRAPID-AMI (High Sensitivity Cardiac Troponin T assay for rapid Rule-out of Acute Myocardial Infarction) study evaluated a rapid "rule-out" acute myocardial infarction (AMI). We evaluated what symptoms were associated with AMI as part of a substudy of TRAPID-AMI. There were 1282 patients evaluated from 12 centers in Europe, the United States of America, and Australia from 2011 to 2013. Multiple symptom variables were prospectively obtained and evaluated for association with the final diagnosis of AMI. Multivariate logistic regression analysis was done, and odds ratios (OR) were calculated. There were 213/1282 (17%) AMIs. Four independent predictors for the diagnosis of AMI were identified: radiation to right arm or shoulder [OR = 3.0; confidence interval (CI): 1.8-5.0], chest pressure (OR = 2.5; CI: 1.3-4.6), worsened by physical activity (OR = 1.7; CI: 1.2-2.5), and radiation to left arm or shoulder (OR = 1.7; CI: 1.1-2.4). In the entire group, 131 (10%) had radiation to right arm or shoulder, 897 (70%) had chest pressure, 385 (30%) worsened with physical activity, and 448 (35%) had radiation to left arm or shoulder. Duration of symptoms was not predictive of AMI. There were no symptoms predictive of non-AMI. Relationship between AMI size and symptoms was also studied. For 213 AMI patients, cardiac troponins I values were divided into 4 quartiles. Symptoms including pulling chest pain, supramammillary right location, and right arm/shoulder radiation were significantly more likely to occur in patients with larger AMIs. In a large multicenter trial, only 4 symptoms were associated with the diagnosis of AMI, and no symptoms that were associated with a non-AMI diagnosis.


Assuntos
Infarto do Miocárdio/diagnóstico , Troponina/sangue , Idoso , Biomarcadores/sangue , Diagnóstico Diferencial , Eletrocardiografia , Serviço Hospitalar de Emergência , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/sangue , Valor Preditivo dos Testes , Reprodutibilidade dos Testes , Estudos Retrospectivos , Fatores de Tempo
12.
Int J Cardiol ; 276: 261-267, 2019 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-30404726

RESUMO

BACKGROUND: We aimed to directly compare the diagnostic and prognostic performance of a dual maker strategy (DMS) with combined testing of copeptin and high-sensitivity (hs) cardiac troponin T (cTnT) at time of presentation with other algorithms for rapid rule-out of acute myocardial infarction (AMI). METHODS: 922 patients presenting to the emergency department with suspected AMI and available baseline copeptin measurements qualified for the present TRAPID-AMI substudy. Diagnostic measures using the DMS (copeptin <10, <14 or < 20 pmol/L and hs-cTnT≤14 ng/L), the 1 h-algorithm (hs-cTnT<12 ng/L and change <3 ng/L at 1 h), as well as the hs-cTnT limit-of-blank (LoB, <3 ng/L) and -detection (LoD, <5 ng/L) were compared. Outcomes were assessed as combined end-points of death and myocardial re-infarction. RESULTS: True-negative rule-out using the DMS could be achieved in 50.9%-62.3% of all patients compared to 35.0%, 45.3% and 64.5% using LoB, LoD or the 1 h-algorithm, respectively. The DMS showed NPVs of 98.1%-98.3% compared to 99.2% for the 1 h-algorithm, 99.4% for the LoB and 99.3% for the LoD. Sensitivities were 93.5%-94.8%, as well as 96.8%, 98.7% and 98.1%, respectively. Addition of clinical low-risk criteria such as a HEART-score ≤ 3 to the DMS resulted in NPVs and sensitivities of 100% with a true-negative rule-out to 33.8%-41.6%. Rates of the combined end-point of death/MI within 30 days ranged between 0.2% and 0.3% for all fast-rule-out protocols. CONCLUSION: Depending on the applied copeptin cut-off and addition of clinical low-risk criteria, the DMS might be an alternative to the hs-cTn-only-based algorithms for rapid AMI rule-out with comparable diagnostic measures and outcomes.


Assuntos
Algoritmos , Eletrocardiografia , Glicopeptídeos/sangue , Infarto do Miocárdio/diagnóstico , Troponina T/sangue , Idoso , Biomarcadores/sangue , Feminino , Humanos , Imunoensaio , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/sangue , Valor Preditivo dos Testes , Prognóstico , Estudos Prospectivos , Fatores de Tempo
13.
Eur Heart J Acute Cardiovasc Care ; 8(5): 395-403, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29737180

RESUMO

BACKGROUND: Copeptin in combination with troponin has been shown to have incremental value for the early rule-out of myocardial infarction, but its performance in Black patients specifically has never been examined. In light of a potential for wider use, data on copeptin in different relevant cohorts are needed. This is the first study to determine whether copeptin is equally effective at ruling out myocardial infarction in Black and Caucasian races. METHODS: This analysis of the CHOPIN trial included 792 Black and 1075 Caucasian patients who presented to the emergency department with chest pain and had troponin-I and copeptin levels drawn. RESULTS: One hundred and forty-nine patients were diagnosed with myocardial infarction (54 Black and 95 Caucasian). The negative predictive value of copeptin at a cut-off of 14 pmol/l (as in the CHOPIN study) for myocardial infarction was higher in Blacks (98.0%, 95% confidence interval (CI) 96.2-99.1%) than Caucasians (94.1%, 95% CI 92.1-95.7%). The sensitivity at 14 pmol/l was higher in Blacks (83.3%, 95% CI 70.7-92.1%) than Caucasians (53.7%, 95% CI 43.2-64.0%). After controlling for age, hypertension, heart failure, chronic kidney disease and body mass index in a logistic regression model, the interaction term had a P value of 0.03. A cut-off of 6 pmol/l showed similar sensitivity in Caucasians as 14 pmol/l in Blacks. CONCLUSIONS: This is the first study to identify a difference in the performance of copeptin to rule out myocardial infarction between Blacks and Caucasians, with increased negative predictive value and sensitivity in the Black population at a cut-off of 14 pmol/l. This also holds true for non-ST-segment elevation myocardial infarction and, although numbers were small, similar trends exist in the normal troponin population. This may have significant implications for early rule-out strategies using copeptin.

14.
J Am Coll Cardiol ; 72(25): 3246-3254, 2018 12 25.
Artigo em Inglês | MEDLINE | ID: mdl-30573026

RESUMO

BACKGROUND: Galectin-3 (Gal-3) has been associated with heart failure (HF) and poor cardiovascular outcomes. However, the effect of longitudinal changes in Gal-3 on clinical outcomes remains unclear. OBJECTIVES: The authors sought to study clinical determinants of change in Gal-3 among community-dwelling individuals. Further, they sought to examine the role of serial Gal-3 measurements in predicting risk of future HF, cardiovascular disease (CVD), and mortality. METHODS: A total of 2,477 participants in the Framingham Heart Study Offspring cohort underwent measurement of plasma Gal-3 levels at 2 examinations (1995 to 1998 and 2005 to 2008). Linear regression models were used to examine clinical correlates of change in Gal-3. Proportional hazards models were used to relate future clinical outcomes with change in Gal-3. RESULTS: The following clinical correlates were associated with greater longitudinal increases in Gal-3 levels: age, female sex, hypertension, diabetes, body mass index, interim development of chronic kidney disease, and HF (p < 0.0001 for all in multivariable model). Change in Gal-3 was associated with future HF (hazard ratio [HR]: 1.39 per 1-SD increase; 95% confidence interval [CI]: 1.13 to 1.71), CVD (HR: 1.29; 95% CI: 1.11 to 1.51), and all-cause mortality (HR: 1.30; 95% CI: 1.17 to 1.46). Change in Gal-3 was associated with both HF with preserved as well as reduced ejection fraction (p < 0.05 for both). CONCLUSIONS: Longitudinal changes in Gal-3 are associated with traditional cardiovascular risk factors and renal disease. In turn, change in Gal-3 predicts future HF, CVD, and mortality in the community. Future studies are needed to determine whether serial Gal-3 measures may be useful in disease prevention.


Assuntos
Doenças Cardiovasculares/sangue , Doenças Cardiovasculares/mortalidade , Galectina 3/sangue , Idoso , Biomarcadores/sangue , Doenças Cardiovasculares/diagnóstico , Estudos de Coortes , Feminino , Humanos , Incidência , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Mortalidade/tendências , Estudos Prospectivos
16.
Open Heart ; 5(2): e000847, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30364466

RESUMO

Objective: Stress testing is commonly performed in emergency department (ED) patients with suspected acute coronary syndrome (ACS). We hypothesised that changes in N-terminal pro-B type natriuretic peptide (NT-proBNP) concentrations from baseline to post-stress testing (stress-delta values) differentiate patients with ischaemic stress tests from controls. Methods: We prospectively enrolled 320 adult patients with suspected ACS in an ED-based observation unit who were undergoing exercise stress echocardiography. We measured plasma NT-proBNP concentrations at baseline and at 2 and 4 hours post-stress and compared stress-delta NT-proBNP between patients with abnormal stress tests versus controls using non-parametric statistics (Wilcoxon test) due to skew. We calculated the diagnostic test characteristics of stress-delta NT-proBNP for myocardial ischaemia on imaging. Results: Among 320 participants, the median age was 51 (IQR 44-59) years, 147 (45.9%) were men, and 122 (38.1%) were African-American. Twenty-six (8.1%) had myocardial ischaemia. Static and stress-deltas NT-proBNP differed at all time points between groups. The median stress-deltas at 2 hours were 10.4 (IQR 6.0-51.7) ng/L vs 1.7 (IQR -0.4 to 8.7) ng/L, and at 4 hours were 14.8 (IQR 5.0-22.3) ng/L vs 1.0 (-2.0 to 10.3) ng/L for patients with ischaemia versus those without. Areas under the receiver operating curves were 0.716 and 0.719 for 2-hour and 4-hour stress-deltas, respectively. After adjusting for baseline NT-proBNP levels, the 4-hour stress-delta NT-proBNP remained significantly different between the groups (p=0.009). Conclusion: Among patients with ischaemic stress tests, static and 4-hour stress-delta NT-proBNP values were significantly higher. Further study is needed to determine if stress-delta NT-proBNP is a useful adjunct to stress testing.

17.
J Perinatol ; 38(11): 1483-1489, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30171214

RESUMO

OBJECTIVE: To investigate if a hemodynamically significant patent ductus arteriosus (hsPDA) leads to elevated high-sensitivity troponin T (hsTnT) and NTproBNP levels in serum. STUDY DESIGN: Infants <34 weeks and <1500 g were prospectively enrolled, except those with major congenital or chromosomal anomalies. An echocardiogram (ECHO) was performed and hsTnT and NTproBNP were measured within 5 days of life and repeated after treatment of hsPDA. Clinical, ECHO, and hsTnT data were analyzed using Student t-test, two proportion z-test, and regression analysis. RESULTS: Seventy infants were enrolled. Infants in the hsPDA group had lower gestation and birth weight. Mean hsTnT and NTproBNP levels in the hsPDA group were higher compared to the group without an hsPDA, with levels being 251.54 vs 161.6 pg/ml, p < 0.01 for hsTnT and 18181.02 vs 3149.23 pg/ml, p < 0.001 for NTproBNP. CONCLUSION: HsPDA leads to increased hsTnT and NTproBNP levels in preterm infants without affecting cardiac function.


Assuntos
Permeabilidade do Canal Arterial/sangue , Peptídeo Natriurético Encefálico/sangue , Fragmentos de Peptídeos/sangue , Troponina T/sangue , Biomarcadores/sangue , Peso ao Nascer , Permeabilidade do Canal Arterial/fisiopatologia , Feminino , Idade Gestacional , Hemodinâmica , Humanos , Lactente Extremamente Prematuro/sangue , Recém-Nascido , Modelos Logísticos , Masculino , Análise Multivariada , Estudos Prospectivos , Curva ROC
18.
Ann Emerg Med ; 72(6): 654-664, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30119942

RESUMO

STUDY OBJECTIVE: We determine how well a new Food and Drug Administration-approved single cardiac troponin T (cTnT) Generation 5 baseline measurement below the level of quantification (6 ng/L) and a novel study-derived baseline and 30-minute cTnT Generation 5 algorithm might adequately exclude acute myocardial infarction in patients with suspected acute coronary syndrome in a US emergency department (ED). METHODS: Patients presenting with any symptoms suspicious for acute coronary syndrome were enrolled at a single US ED. Baseline and 30-minute blood samples were obtained and cTnT Generation 5 levels were later batch analyzed in an independent core laboratory. Acute myocardial infarction diagnosis was adjudicated by a cardiologist and an emergency physician. RESULTS: Of the 569 study patients, 44 (7.7%) had an acute myocardial infarction diagnosis. One hundred sixty-four patients (28.8%) had a presentation cTnT Generation 5 level less than 6 ng/L, and none of these individuals had an acute myocardial infarction (negative predictive value of 100% [95% confidence interval 97.8% to 100.0%] and sensitivity of 100% [95% confidence interval 92.0% to 100.0%]). A baseline cTnT Generation 5 value of less than 8 ng/L and a 30-minute Δ of less than 3 ng/L were present in 221 patients (41.0%), and none had acute myocardial infarction (negative predictive value of 100% [95% confidence interval 98.3% to 100.0%] and sensitivity of 100% [95% confidence interval 92.0% to 100.0%]). CONCLUSION: In a single US ED, a single baseline cTnT Generation 5 measurement less than 6 mg/L and values at baseline less than 8 ng/L and a 30-minute Δ of less than 3 ng/L ruled out acute myocardial infarction in 28.8% and 41.0% of patients, respectively. Additional multicenter US studies evaluating these ultrarapid acute myocardial infarction rule-out guidelines are needed, especially to narrow the confidence intervals.


Assuntos
Biomarcadores/sangue , Infarto do Miocárdio/diagnóstico , Troponina T/sangue , Idoso , Algoritmos , Testes Diagnósticos de Rotina , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/metabolismo , Guias de Prática Clínica como Assunto , Estudos Prospectivos , Sensibilidade e Especificidade
19.
Contemp Clin Trials ; 73: 111-122, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30138718

RESUMO

Prior evidence suggests that vitamin D supplementation may reduce fall risk, but existing data are inconsistent and insufficient to guide policy. We designed a two-stage Bayesian response-adaptive dose-finding and seamless confirmatory randomized trial of vitamin D supplementation to prevent falls. Up to 1200 community-dwelling persons, aged ≥70 years, of predominantly white and African-American race, with serum 25(OH)D concentrations of 10-29 ng/mL and at elevated fall risk, will be randomized to one of four vitamin D3 (cholecalciferol) supplement doses: 200 (control), 1000, 2000, or 4000 IU/day and treated for up to 2 years. Stage 1 is designed to identify the best of the non-control doses for fall prevention. If a best dose is selected, Stage 2 will start seamlessly, with enrollees assigned to control or the best dose in Stage 1 continuing on that dose unchanged, enrollees assigned to the two non-control, non-best doses in Stage 1 switched to the best dose, and new enrollees randomly assigned 1:1 to control or the best dose. In Stage 2, we will compare the control dose group to the best dose group to potentially confirm the efficacy of that dose for fall prevention. The primary outcome measure in both stages is time to first fall or death, whichever comes first. Falls are ascertained from calendars, scheduled interviews, or interim self-reports. Secondary outcome measures include time to each component of the composite primary outcome and gait speed. Additional outcomes include the Short Physical Performance Battery score, physical activity level (assessed by accelerometry), and frailty score. CLINICAL TRIAL REGISTRATION: NCT02166333.


Assuntos
Acidentes por Quedas/prevenção & controle , Colecalciferol/administração & dosagem , Suplementos Nutricionais , Vitaminas/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Teorema de Bayes , Método Duplo-Cego , Humanos
20.
Am J Emerg Med ; 36(10): 1849-1854, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30007549

RESUMO

PURPOSE: Differentiation of type 1 (T1MI) from type 2 myocardial infarction (T2MI) is important as recommended treatments for each differ. Patients with T2MI may have more/earlier cardiac wall stress resulting in an increased N-terminal pro B-type natriuretic peptide (NT-proBNP)/cTnT generation 5 ratio (cTnT Gen 5). METHODS: Emergency Department (ED) patients presenting with symptoms suspicious for acute coronary syndrome (ACS) were enrolled from 2013 to 2015. Baseline blood samples were collected within 60 min of a triage ECG, with additional draws at 30, 60 and 180 min. NT-proBNP and cTnT Gen 5 levels were measured later in an independent laboratory. Acute myocardial infarction (AMI) was adjudicated using the Third Universal Definition of Myocardial Infarction. RESULTS: 575 patients were enrolled with 44 (7.7%) having AMI [25 T1MI (59.1%) and 18 T2MI (40.9%)]. Patient characteristics showed very few AMI type differences so accurate clinical differentiation was difficult. The median NT-proBNP/cTnT Gen 5 ratios were significantly higher in T2MI when compared to T2MI at baseline and 30, 60 and 180 min later [7.3 v 53.0 (p = 0.003), 5.8 v 49.5 (p = 0.002), 6.3 v 47.5 (p = 0.003) and 4.3 v 33.7 (p = 0.016) respectively]. CONCLUSIONS: The clinical determination of whether an AMI is type 1 or 2 is difficult as the ED patient characteristics of each are similar. The NT-proBNP/cTnT Gen 5 ratio can aid in making this differentiation. Additional multicenter trials are needed to validate our results.


Assuntos
Infarto do Miocárdio/sangue , Peptídeo Natriurético Encefálico/sangue , Fragmentos de Peptídeos/sangue , Troponina T/sangue , Biomarcadores/sangue , Diagnóstico Diferencial , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/classificação
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