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1.
Eur Heart J Case Rep ; 8(9): ytae473, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-39319180

RESUMO

Background: Takayasu arteritis (TAK) is a systemic non-inflammatory vasculitis that primarily affects large- and medium-sized arteries. Case summary: We report the case of a 57-year-old woman with a history of coronary artery bypass grafting (CABG) 7 years prior, who was referred for a stress echo due to chest pain. Transthoracic echocardiography revealed the left ventricle at the upper limits of normal with preserved contractility, as well as circumferential thickening of the aortic root, causing severe aortic regurgitation (AR). Cardiac computed tomography and angiography demonstrated diffuse thickening of the aortic wall from the aortic root to the descending thoracic aorta, extending to the left carotid artery and significant stenosis of the left subclavian artery. Coronary angiography showed severe narrowing of the left main coronary ostium with ostial stenosis and total occlusion of the right coronary and left internal mammary arteries. Magnetic angiography highlighted thickening of the aortic wall, while no active inflammation was detected on positron emission tomography. These findings suggested Takayasu aortitis with chronic inflammation. Discussion: In young patients, particularly women, who present with angina and coronary ostial stenosis, Takayasu arteritis should be considered in the differential diagnosis. Aortic regurgitation (AR) is a serious complication, and its surgical management can be challenging.

2.
Front Endocrinol (Lausanne) ; 15: 1405251, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-39129922

RESUMO

Background: Thyroid hormone (TH) appears to have a reparative action on the postinfarcted myocardium. This novel action was recently tested in a pilot, randomized, double-blind, placebo-controlled trial (ThyRepair). The present study performed a post-hoc analysis of data from the ThyRepair study to provide further insights into the novel actions of TH on the human postischemic myocardium. Methods: Data from 41 patients participating in the ThyRepair study (n = 20 placebo and n = 21 LT3) were included in the analysis. LT3 treatment started after stenting and continued intravenously for 48 h. All patients had cardiac magnetic resonance (CMR) at hospital discharge; left ventricular (LV) ejection fraction (LVEF%), LV end-diastolic volume index (LVEDVi; mL/m2), LV end-systolic volume index (LVESVi; mL/m2), infarct volume (IV), left ventricular mass index (LVMi) as edema index, and microvascular obstruction (MVO) were assessed. Patients were divided into two groups based on the median value of the IV: patients with IV ≤ 20% of the LV (group A) and patients with IV > 20% (group B). CMR measurements at discharge are expressed as mean ± SD. Results: In group A, the placebo and T3-treated groups had similar LVEF% (56.8 ± 10.2 vs. 52.2 ± 10.5), LVEDVi (90.9 ± 19.8 vs. 92.8 ± 14.5), and LVESVi (40.8 ± 18.2 vs. 44.9 ± 14.1) at discharge. In group B, LVEDVi and LVESVi were 112 ± 23.8 and 68.3 ± 21.5 for placebo vs. 91.8 ± 18.6 and 49.0 ± 14.0 for the T3-treated group, respectively, p < 0.05. LVEF% was significantly increased in the T3-treated group vs. placebo, 47.3 ± 6.5 vs. 39.9 ± 8.7, p < 0.05. In group B, CMR LVMi was lower in T3-treated patients vs. placebo but did not reach statistical significance (p = 0.1). MVO was 1.95 ± 2.2 in placebo vs. 0.84 ± 0.9 in the LT3-treated group, p = 0.15. Conclusion: The present study suggests that acute LT3 treatment may exert more favorable effects on the recovery of cardiac function in patients with large infarct size. Furthermore, it signals a potential effect of LT3 on myocardial edema and microvascular obstruction. These novel findings merit further investigation in large trials.


Assuntos
Função Ventricular Esquerda , Humanos , Masculino , Feminino , Método Duplo-Cego , Pessoa de Meia-Idade , Idoso , Função Ventricular Esquerda/efeitos dos fármacos , Infarto do Miocárdio/tratamento farmacológico , Infarto do Miocárdio/patologia , Hormônios Tireóideos/uso terapêutico , Volume Sistólico/efeitos dos fármacos , Projetos Piloto , Tri-Iodotironina/uso terapêutico , Tri-Iodotironina/administração & dosagem , Tri-Iodotironina/sangue
3.
J Pers Med ; 14(6)2024 May 24.
Artigo em Inglês | MEDLINE | ID: mdl-38929783

RESUMO

Direct oral anticoagulants (DOACs) are the standard treatment for thromboembolic protection in atrial fibrillation (AF) patients. Epigenetic modifications, such as DNA methylation and microRNAs, have emerged as potential biomarkers of AF. The epigenetics of DOACs is still an understudied field. It is largely unknown whether epigenetic modifications interfere with DOAC response or whether DOAC treatment induces epigenetic modifications. To fill this gap, we started the miR-CRAFT (Circulating microRNAs and DNA methylation as regulators of Direct Oral Anticoagulant Response in Atrial Fibrillation) research study. In miR-CRAFT, we follow, over time, changes in DNA methylation and microRNAs expression in naïve AF patients starting DOAC treatment. The ultimate goal of miR-CRAFT is to identify the molecular pathways epigenetically affected by DOACs, beyond the coagulation cascade, that are potentially mediating DOAC pleiotropic actions and to propose specific microRNAs as novel circulating biomarkers for DOAC therapy monitoring. We herein describe the study design and briefly present the progress in participant enrolment.

6.
Diabetes Res Clin Pract ; 211: 111664, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38604446

RESUMO

AIMS: The impact of newly detected diabetes mellitus (NDDM) on metabolic parameters and extent of myocardial necrosis in patients with acute coronary syndrome (ACS) is not fully explored. We examined the impact of NDDM on cardiometabolic characteristics and myocardial necrosis in ACS patients. METHODS: CALLINICUS-Hellas Registry is an ongoing prospective multicenter observational study evaluating the adherence to lipid-lowering therapy (LLT) among ACS patients in Greece. Three groups were created: a) patients with NDDM (abnormal fasting glucose, HbA1c ≥ 6.5 % and no previous history of DM), b) patients without known DM and HbA1c < 6.5 % (non-DM) and c) patients with prior DM. RESULTS: The prevalence of NDDM among 1084 patients was 6.9 %. NDDM patients had lower HDL-C [38 (32-45) vs 42 (36-50) mg/dL] and higher triglycerides levels [144 (104-231) vs 115 (87-152) mg/dL] compared to non-DM patients (p < 0.05). NDDM patients featured both higher body mass index [29.5 (26.4-34.3) vs 27.1 (24.9-29.9) kg/m2] and waist circumference [107 (100-114) vs 98 (91-106) cm] compared to non-DM patients (p < 0.05). In addition, NDDM patients had more extensive myocardial necrosis than patients with prior DM. CONCLUSIONS: ACS patients with NDDM have an adverse cardiometabolic profile similar to patients with prior DM and have more extensive myocardial insult.


Assuntos
Síndrome Coronariana Aguda , Humanos , Síndrome Coronariana Aguda/sangue , Síndrome Coronariana Aguda/complicações , Síndrome Coronariana Aguda/epidemiologia , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Estudos Prospectivos , Diabetes Mellitus/epidemiologia , Hemoglobinas Glicadas/metabolismo , Hemoglobinas Glicadas/análise , Glicemia/metabolismo , Glicemia/análise , Grécia/epidemiologia , Isquemia Miocárdica/epidemiologia , Isquemia Miocárdica/sangue , Sistema de Registros , Prevalência
7.
J Cardiol ; 83(5): 313-317, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-37979719

RESUMO

BACKGROUND: Current guidelines recommend a rhythm control strategy in patients with symptomatic atrial fibrillation (AF) while catheter ablation has been shown to be a safer and more efficacious approach than antiarrhythmic medications. METHODS: HECMOS was a nationwide snapshot survey of cardiorenal morbidity in hospitalized cardiology patients. In this sub-study, we included 276 cases who had a history of AF, particularly on the rhythm strategy, and catheter ablation procedures had been performed before the index admission. RESULTS: Among 276 AF patients (mean age: 76.4 ±â€¯11.5 years, 58 % male), 60.9 % (N = 168) had persistent AF and 39.1 % (N = 108) had paroxysmal AF. Heart failure was the main cause of admission in 54.3 % (N = 145) of the patients, while 14.1 % (N = 39) were admitted due to paroxysmal AF, 7.3 % (N = 20) due to bradyarrhythmic reasons, and 6.5 % (N = 18) suffered from acute coronary syndrome. Most importantly, heart failure with reduced ejection fraction was present in 76 (27 %) patients. Only 10 patients out of the total (3 %, mean age 59.7 years) had undergone AF ablation while electrical cardioversion had been attempted in 37 (13.4 %) patients. Interestingly, in this AF population with heart failure, 3.6 % (N = 10) had a defibrillator implanted (4 single-chamber), and only 1.5 % (N = 4) had a cardiac resynchronization therapy defibrillator (CRT-D). CONCLUSION: High prevalence of persistent AF was detected in hospitalized patients, with heart failure being the leading cause of admission and main co-morbidity. Rhythm control strategies are notably underused, along with CRT-D implantation in patients with AF and heart failure.


Assuntos
Fibrilação Atrial , Ablação por Cateter , Insuficiência Cardíaca , Humanos , Masculino , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Feminino , Fibrilação Atrial/terapia , Fibrilação Atrial/tratamento farmacológico , Antiarrítmicos/uso terapêutico , Cardioversão Elétrica , Prevalência , Ablação por Cateter/efeitos adversos , Resultado do Tratamento
8.
Hellenic J Cardiol ; 75: 21-25, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-37127207

RESUMO

BACKGROUND: The Cocoon patent foramen ovale (PFO) occluder is a new device especially designed for transcatheter closure of PFO. This occluder has some distinctive structural modifications aimed at reducing the risk of major complications of transcatheter PFO closure. In this report we present our initial experience to evaluate the efficacy and safety of the Cocoon PFO occluder in 253 patients who underwent transcatheter PFO closure. METHODS: The study cohort included 253 patients (median age 45 years) with embolic stroke of undetermined source who underwent attempted transcatheter closure of PFO for secondary prevention of paradoxical embolism. Patients were enrolled retrospectively from five sites in Greece and one in Romania between December 2016 and January 2021, and the median follow-up period was 28 months (range 12-48 months). Clinical and laboratory data from each participating center were sent to an electronic registry for evaluation and statistical analysis. RESULTS: The Cocoon PFO occluder was permanently implanted in all patients. At 6 months, complete occlusion of PFO was observed in 251/253 (99.2%) patients. Three (1.2%) patients had a trivial residual shunt. Thrombus formation on the device, which was successfully treated with recombinant tissue plasminogen activator infusion, was observed in one (0.4%) patient. No other complications occurred. During a median follow-up period of 28 months, 3 (1.2%) patients, aged 64-67 years, developed new onset paroxysmal atrial fibrillation. No neurologic events, cardiac erosions, allergic reactions to nickel, or thrombus formation occurred. CONCLUSION: The Cocoon PFO occluder is an effective and safe device that adds to our armamentarium for transcatheter closure of PFO.


Assuntos
Forame Oval Patente , Dispositivo para Oclusão Septal , Trombose , Humanos , Pessoa de Meia-Idade , Forame Oval Patente/complicações , Forame Oval Patente/cirurgia , Estudos Retrospectivos , Ativador de Plasminogênio Tecidual , Próteses e Implantes , Resultado do Tratamento , Cateterismo Cardíaco/efeitos adversos , Dispositivo para Oclusão Septal/efeitos adversos
10.
J Cardiovasc Pharmacol ; 81(2): 141-149, 2023 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-36410034

RESUMO

ABSTRACT: GReek-AntiPlatElet Atrial Fibrillation registry is a multicenter, observational, noninterventional study of atrial fibrillation patients undergoing percutaneous coronary intervention. Primary endpoint included clinically significant bleeding rate at 12 months between different antithrombotic regimens prescribed at discharge; secondary endpoints included major adverse cardiovascular events and net adverse clinical events. A total of 647 patients were analyzed. Most (92.9%) were discharged on novel oral anticoagulants with only 7.1% receiving the vitamin K antagonist. A little over half of patients (50.4%) received triple antithrombotic therapy (TAT)-mostly (62.9%) for ≤1 month-whereas the rest (49.6%) received dual antithrombotic therapy (DAT). Clinically significant bleeding risk was similar between TAT and DAT [Hazard ratio (HR) = 1.08; 95% confidence interval (CI), 0.66-1.78], although among TAT-receiving patients, the risk was lower in those receiving TAT for ≤1 month (HR = 0.50; 95% CI, 0.25-0.99). Anticoagulant choice (novel oral anticoagulant vs. vitamin K antagonist) did not significantly affect bleeding rates ( P = 0.258). Age, heart failure, leukemia/myelodysplasia, and acute coronary syndrome were associated with increased bleeding rates. Risk of major adverse cardiovascular events and net adverse clinical events was similar between ΤAT and DAT (HR = 1.73; 95% CI, 0.95-3.18, P = 0.075 and HR = 1.39; 95% CI, 0.93-2.08, P = 0.106, respectively). In conclusion, clinically significant bleeding and ischemic rates were similar between DAT and TAT, although TAT >1 month was associated with higher bleeding risk.


Assuntos
Fibrilação Atrial , Intervenção Coronária Percutânea , Humanos , Fibrilação Atrial/tratamento farmacológico , Fibrinolíticos/efeitos adversos , Grécia , Anticoagulantes/efeitos adversos , Hemorragia/induzido quimicamente , Intervenção Coronária Percutânea/efeitos adversos , Sistema de Registros , Vitamina K , Inibidores da Agregação Plaquetária/efeitos adversos
11.
Artigo em Inglês | MEDLINE | ID: mdl-35805716

RESUMO

Tissue hypoxia is one of the main pathophysiologic mechanisms in sepsis and particularly in COVID-19. Microvascular dysfunction, endothelialitis and alterations in red blood cell hemorheology are all implicated in severe COVID-19 hypoxia and multiorgan dysfunction. Tissue hypoxia results in tissue injury and remodeling with re-emergence of fetal programming via hypoxia-inducible factor-1α (HIF-1a)-dependent and -independent pathways. In this context, thyroid hormone (TH), a critical regulator of organ maturation, may be of relevance in preventing fetal-like hypoxia-induced remodeling in COVID-19 sepsis. Acute triiodothyronine (T3) treatment can prevent cardiac remodeling and improve recovery of function in clinical settings of hypoxic injury as acute myocardial infarction and by-pass cardiac surgery. Furthermore, T3 administration prevents tissue hypoxia in experimental sepsis. On the basis of this evidence, the use of T3 treatment was proposed for ICU (Intensive Care Unit) COVID-19 patients (Thy-Support, NCT04348513). The rationale for T3 therapy in severe COVID-19 and preliminary experimental and clinical evidence are discussed in this review.


Assuntos
Tratamento Farmacológico da COVID-19 , Sepse , Humanos , Hipóxia/metabolismo , Hormônios Tireóideos/metabolismo , Hormônios Tireóideos/uso terapêutico , Tri-Iodotironina/uso terapêutico
12.
Thyroid ; 32(6): 714-724, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35297659

RESUMO

Background: Thyroid hormone has a differential action on healthy and ischemic heart. Triiodothyronine (T3) administration improved postischemic cardiac function while it limited apoptosis in experimentally induced ischemia. Thus, the present study investigated the potential effects of acute liothyronine (LT3) treatment in patients with anterior myocardial infarction. Methods: This study is a pilot, randomized, double-blind, placebo-controlled trial (ThyRepair study). We randomized 52 patients and analyzed data from 37 patients (n = 16 placebo and n = 21 LT3), per prespecified per protocol analysis. We excluded three patients who had died of cardiovascular causes (one in placebo and two in LT3 arm), four with small infarct size below a pre-specified threshold (in the placebo arm), and the rest, who lacked follow-up data. LT3 treatment started after stenting as an intravenous (i.v.) bolus injection of 0.8 µg/kg of LT3 followed by a constant infusion of 0.113 µg/kg/h i.v. for 48 hours. All patients had cardiac magnetic resonance (CMR) at hospital discharge and 6 months follow-up. The primary end point was CMR left ventricular (LV) ejection fraction (LVEF) and secondary endpoints were LV volumes, infarct volume (IV), and safety. Results: The CMR LVEF% at 6 months was 53.6 ± 9.5 for the LT3-treated group and 48.6 ± 11 for placebo, p = 0.15. Acute LT3 treatment resulted in a significantly lower LV end-diastolic volume index (92.2 ± 16.8 mL/m2 vs. 107.5 ± 22.2, p = 0.022) and LV systolic volume index (47.5 ± 13.9 mL/m2 vs. 61.3 ± 21.7, p = 0.024) at hospital discharge, but not at 6 months. There was no statistically significant difference in CMR IV at hospital discharge between the groups (p = 0.24). CMR IV tended to be lower in the LT3-treated group at 6 months (18.7 ± 9.5 vs. 25.9 ± 11.7, in placebo, p = 0.05). Serious, life-threatening events related to LT3 treatment were not observed. A tendency for an increased incidence of atrial fibrillation (AF) was found in the LT3 group during the first 48 hours (19% for T3 group vs. 5% for placebo, p = 0.13). Conclusion: This pilot randomized, placebo-controlled trial study suggests potential favorable effects (acute cardiac dilatation and 6-month IV) as well as potential concerns regarding a higher risk of AF after LT3 administration early after myocardial infarction, which should be tested in a larger scale study.


Assuntos
Infarto do Miocárdio , Tri-Iodotironina , Angioplastia , Método Duplo-Cego , Humanos , Infarto do Miocárdio/tratamento farmacológico , Projetos Piloto , Resultado do Tratamento , Tri-Iodotironina/uso terapêutico
13.
J Clin Med ; 10(24)2021 Dec 14.
Artigo em Inglês | MEDLINE | ID: mdl-34945151

RESUMO

Tissue hypoxia occurs in various conditions such as myocardial or brain ischemia and infarction, sepsis, and trauma, and induces cellular damage and tissue remodeling with recapitulation of fetal-like reprogramming, which eventually results in organ failure. Analogies seem to exist between the damaged hypoxic and developing organs, indicating that a regulatory network which drives embryonic organ development may control aspects of heart (or tissue) repair. In this context, thyroid hormone (TH), which is a critical regulator of organ maturation, physiologic angiogenesis, and mitochondrial biogenesis during fetal development, may be of important physiological relevance upon stress (hypoxia)-induced fetal reprogramming. TH signaling has been implicated in hypoxic tissue remodeling after myocardial infarction and T3 prevents remodeling of the postinfarcted heart. Similarly, preliminary experimental evidence suggests that T3 can prevent early tissue hypoxia during sepsis with important physiological consequences. Thus, based on common pathways between different paradigms, we propose a possible role of TH in tissue hypoxia after sepsis with the potential to reduce secondary organ failure.

16.
ESC Heart Fail ; 7(6): 3676-3684, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32935475

RESUMO

AIMS: Despite the existence of many studies, there are still limited data about the characteristics of myocarditis in Greece. This led to the creation of the Greek Myocarditis Registry aiming to document the different symptoms and treatment of myocarditis, assess possible prognostic factors, and find similarities and differences to what is already published in literature. This paper is a preliminary descriptive analysis of this Registry. METHODS AND RESULTS: We analysed data for the hospitalization period of all patients included in the Registry from December 2015 until November 2017. Statistics are reported as frequency (%) or median and inter-quartile range (IQR) as appropriate. In total, 146 patients were included; 83.3% of the patients reported an infection during the last 3 months. The most common symptom, regardless of the underlying infection, was chest pain (82.2%) followed by dyspnoea (18.5%), while the most common finding in clinical examination was tachycardia (26.7%). Presentation was more frequent in the winter months. ECG findings were not specific, with the repolarization abnormalities being the most frequent (60.3%). Atrial fibrillation was observed in two patients, both of whom presented with a reduced ventricular systolic function. Left ventricular ejection fraction changed significantly during the hospitalization [55% (IQR: 50-60%) on admission vs. 60% (IQR: 55-60%) on discharge, P = 0.0026]. Cardiac magnetic resonance was performed in 88 patients (61%), revealing mainly subepicardial and midcardial involvement of the lateral wall. Late gadolinium enhancement was present in all patients, while oedema was found in 39 of them. Only 11 patients underwent endomyocardial biopsy. Discharge medication consisted mainly of beta-blockers (71.9%) and angiotensin-converting enzyme inhibitors (41.8%), while 39.7% of the patients were prescribed both. CONCLUSIONS: This preliminary analysis describes the typical presentation of myocarditis patients in Greece. It is a first step in developing a better prognostic model for the course of the disease, which will be completed after the incorporation of the patients' follow-up data.

17.
Clin Cardiol ; 43(10): 1142-1149, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32691901

RESUMO

BACKGROUND: Reports from countries severely hit by the COVID-19 pandemic suggest a decline in acute coronary syndrome (ACS)-related hospitalizations. The generalizability of this observation on ACS admissions and possible related causes in countries with low COVID-19 incidence are not known. HYPOTHESIS: ACS admissions were reduced in a country spared by COVID-19. METHODS: We conducted a nationwide study on the incidence rates of ACS-related admissions during a 6-week period of the COVID-19 outbreak and the corresponding control period in 2019 in Greece, a country with strict social measures, low COVID-19 incidence, and no excess in mortality. RESULTS: ACS admissions in the COVID-19 (n = 771) compared with the control (n = 1077) period were reduced overall (incidence rate ratio [IRR]: 0.72, P < .001) and for each ACS type (ST-segment elevation myocardial infarction [STEMI]: IRR: 0.76, P = .001; non-STEMI: IRR: 0.74, P < .001; and unstable angina [UA]: IRR: 0.63, P = .002). The decrease in STEMI admissions was stable throughout the COVID-19 period (temporal correlation; R2 = 0.11, P = .53), whereas there was a gradual decline in non-STEMI/UA admissions (R2 = 0.75, P = .026) following the progressively stricter social measures. During the COVID-19 period, patients admitted with ACS presented more frequently with left ventricular systolic impairment (22.2 vs 15.5% control period; P < .001). CONCLUSIONS: We observed a reduction in ACS hospitalizations during the COVID-19 outbreak in a country with strict social measures, low community transmission, and no excess in mortality. Medical care avoidance behavior is an important factor for these observations, while a true reduction of the ACS incidence due to self-isolation/quarantining may have also played a role.


Assuntos
Síndrome Coronariana Aguda/epidemiologia , COVID-19/epidemiologia , Hospitalização/estatística & dados numéricos , Idoso , Angiografia Coronária , Feminino , Grécia/epidemiologia , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Pandemias , Estudos Retrospectivos , SARS-CoV-2
18.
Trials ; 21(1): 573, 2020 Jun 26.
Artigo em Inglês | MEDLINE | ID: mdl-32586399

RESUMO

OBJECTIVES: Tissue hypoxia is the main cause of multi-organ dysfunction in sepsis. However, effective pharmacological treatments to combat sepsis-induced tissue hypoxia are not available. Emerging experimental and clinical evidence reveals an evolutionary conserved action of thyroid hormone (TH) to adapt injured tissue to hypoxic conditions via its action on p38 MAPK, Akt signaling pathways. In addition, TH has favorable effects on the immune system and viral load in infected tissue. Non-Thyroid Illness Syndrome is common in sepsis, acute myocardial infarction and trauma and is associated with increased mortality. Thus, TH may be a novel treatment in the setting of critical illness due to viral infection in which hypoxia prevails. The present study aims to address the efficacy and safety of acute administration of triiodothyronine (T3) in critically ill COVID-19 infected patients requiring mechanical respiratory support or Extra Corporeal Membrane Oxygenation (ECMO). TRIAL DESIGN: This study is a phase II, parallel, 2-arm (1:1 ratio), multi-centre, prospective, randomized, double-blind, placebo controlled trial. PARTICIPANTS: Male and female patients aged over 18 years old who are diagnosed with pulmonary infection due to COVID-19, admitted to Intensive Care Unit and requiring mechanical ventilation or ECMO will be enrolled in this trial. Patients will be excluded in cases of pregnancy, severe systemic disease with life expectancy less than 6 months, participation in another trial of an investigational drug or device, corticosteroid and/or sympathomimetic use before initiation of treatment. All data will be collected in electronic CRF files. Participants will start to be recruited from the ICU center of "ATTIKO" University Hospital in Greece. We aim to include two more clinical sites in the trial one from Greece and one from Germany INTERVENTION AND COMPARATOR: Intervention: T3 Solution for injection 10 µg/ml. The dose administered will be 0.8g/kg i.v. bolus and will be followed by an infusion of 0.113g. kg-1.h-1 i.v. for 48 hours (therapeutic dose). After the first 48h, a maintenance dose will be administered corresponding to 50% of the therapeutic dose (0.057g. kg-1.h-1 i.v.). Drug administration will stop after successful weaning or end of follow up (maximum 30 days). Comparator: Placebo with composition and dosage identical apart from the active substance. MAIN OUTCOMES: The primary outcome assessed in the present study will be the percentage of patients successfully weaned after 30 days of follow-up. Successful weaning is defined as no requirement for ventilatory support after extubation (mechanical support) or support from ECMO for 48 hours. RANDOMISATION: An allocation sequence to one of the groups will be prepared by the Sponsor of the study. A 1:1 treatment allocation will be adopted. An electronic CRF will be used incorporating IWRS in order to assure proper randomization and unblinding in emergency cases. The representative of the sponsor will get a copy of randomization codes. The information of the randomization codes will then be locked in the database until the time at which an interim analysis or final analysis is performed. BLINDING (MASKING): Participants, caregivers, and all investigators assessing the outcomes will be blinded to group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The sample size of 60 patients (that indicates 30 subjects for each group) will have 84% power to detect the estimated difference between the two study groups. The criterion for significance (alpha) has been set at 0.05 and the test is 2-tailed. TRIAL STATUS: Protocol number T3inj-02/ThySupport, version 03, May 11, 2020. The trial is not recruiting yet. The trial will start recruitment June 18th 2020. Estimated recruitment will finish June 18th, 2021. TRIAL REGISTRATION: Triiodothyronine for the Treatment of Critically Ill Patients With COVID-19 Infection (Thy-Support), ClinicalTrials.gov Identifier: NCT04348513, date of trial registration: April 16, 2020, EudraCT Identifier: 2020-001623-13, date of trial registration: April 22, 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Assuntos
Betacoronavirus , Infecções por Coronavirus/tratamento farmacológico , Pneumonia Viral/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto , Tri-Iodotironina/uso terapêutico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , COVID-19 , Estado Terminal , Método Duplo-Cego , Oxigenação por Membrana Extracorpórea , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pandemias , Estudos Prospectivos , Respiração Artificial , SARS-CoV-2 , Tri-Iodotironina/efeitos adversos , Adulto Jovem , Tratamento Farmacológico da COVID-19
19.
Hellenic J Cardiol ; 60(5): 271-275, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30321654

RESUMO

Cardiovascular disease (CVD) is a significant and ever-growing problem in Europe, accounting for nearly 45% of all deaths and leading to significant morbidity. Greece is one of the European Union member states that top the list of deaths due to ischemic heart disease and stroke, a fact that is mainly attributed to unfavorable changes in modifiable risk factors. The aim of this review is to examine the latest evidence on the most important CVD risk factors. According to studies conducted during the last two decades, the prevalence of arterial hypertension, hypercholesterolemia, diabetes mellitus, and obesity remained relatively stable or increased. The decrease in the prevalence of active smokers and the increase in physical activity, during the last few years, are the main favorable risk modifications in the Greek population. Nevertheless, citizens of Greece seem to gradually adopt unhealthy dietary habits by moving away from Mediterranean diet, as issue that is intensified after the outbreak of the Greek debt crisis. Furthermore, the inability of some patients to afford their medications and the possible health care deficiencies as well as the increasing prevalence of depression may make the situation even worse. During the financial crisis, CVD mortality seems to have remained unaffected, but there is evidence that the incidence of cardiovascular events is increasing. More effort is needed to control established and emerging CVD risk factors among the Greek population.


Assuntos
Doenças Cardiovasculares/complicações , Doenças Cardiovasculares/epidemiologia , Morbidade/tendências , Adulto , Idoso , Doenças Cardiovasculares/mortalidade , Estudos Transversais , Depressão/epidemiologia , Diabetes Mellitus/epidemiologia , Dieta Mediterrânea/psicologia , Dieta Mediterrânea/estatística & dados numéricos , Feminino , Grécia/epidemiologia , Humanos , Hipercolesterolemia/epidemiologia , Hipertensão/epidemiologia , Masculino , Pessoa de Meia-Idade , Isquemia Miocárdica/mortalidade , Obesidade/epidemiologia , Prevalência , Estudos Prospectivos , Fatores de Risco , Fumar/epidemiologia , Acidente Vascular Cerebral/mortalidade
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