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Myocardial Infarction clinical trials

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NCT ID: NCT06376630 Recruiting - Clinical trials for Myocardial Infarction

Study of Microvascular Dysfunction, CFR and Cardioprotective Effect of Early Administration of Esmolol in MI

ESMO-VASCMI
Start date: January 29, 2024
Phase: N/A
Study type: Interventional

Study rationale: to evaluate clinical and prognostic relevance of microvascular dysfunction, coronary flow reserve and cardioprotective effects of iv administration of esmolol in patients with myocardial infarction. First substudy is an open randomized trial evaluating the efficacy and safety of early intravenous administration of esmolol in patients with acute ST-segment elevation myocardial infarction (MI) and relative contraindications to administration of other intravenous β1-adrenergic blocker (metoprolol etс.). Сomparison group will include patients who have not received intravenous β1-adrenergic blocker. Secondary outcome in this substudy is the degree of microvascular obstruction and infarct size according to MRI with gadolinium delayed enhancement. Second substudy examines the quantitative parameters of coronary physiology in patients with MI and multivessel disease. Changes of coronary physiology measurements over time ((iFR, Pd/Pa, FFR, delta FFR, gradient FFR per time unit (dFFR(t)/dt), pullback pressure gradient (PPG)) measured in the infarct-related artery and in non-infarct-related arteries with diameter stenosis of 50-85% immediately after the completion of a primary percutaneous coronary intervention and during a second hospitalization (30-45 days after STEMI) will be evaluated. The comparison changes of coronary physiology over time with presence of an MVO and infarct size determined by MRI. The model of calculating coronary flow reserve (CFR) based on tridimensional reconstruction of coronary arteries and coronary physiology parameters as measured during coronary angiography will be developed. The influence of coronary physiology parameters measured after complete myocardial revascularization by PCI, and derived CFR in patients with MI on long-term clinical outcomes will be evaluated, based on prospective data collection. Primary composite outcome in all substudies will be the sum of adverse cardiac outcomes (congestive heart failure, episodes of recurrent congestive heart failure worsening resulting in hospitalizations, cardiac mortality, MI recurrences, unstable angina, urgent myocardial revascularization) within > 12 months post-infarction. Secondary composite outcome in all substudies is the degree of microvascular obstruction and infarct size evaluated by MRI with gadolinium delayed enhancement.

NCT ID: NCT06374277 Recruiting - Stroke Clinical Trials

Pharmacy-led Transitions of Care Intervention to Improve Medication Adherence

MedAAAction
Start date: April 6, 2024
Phase: N/A
Study type: Interventional

Socioeconomically disadvantaged populations with multiple chronic conditions have high rates of nonadherence to essential chronic disease medications after hospital discharge. Medication nonadherence after hospital discharge is significantly associated with increased mortality and higher rates of readmissions and costs among these patients. Major patient-reported barriers to essential medication use after hospital discharge among low-income individuals are related to social determinants of health (SDOH) and include: 1) financial barriers , 2) transportation barriers, and 3) system-level barriers. Although, medication therapy management services are important during care transitions, these services have not proven effective in improving medication adherence after hospital discharge, highlighting a critical need for innovative interventions. The Medication Affordability, Accessibility, and Availability in Care Transitions (Med AAAction) Study will test the effectiveness of a pharmacy-led care transitions intervention versus usual care through a pragmatic randomized controlled trial of 388 Medicaid and uninsured hospital in-patients with MCC from three large healthcare systems in Tennessee. The intervention will involve: 1) medications with zero copay, 2) bedside delivery then home delivery of medications, and 3) care coordination provided by certified pharmacy technicians/health coaches to assist with medication access, medication reconciliation, and rapid and ongoing primary care follow-up. We will examine the impact of the intervention during 12 months on 1) medication adherence (primary outcome) and 2) rapid primary care follow-up, 30-day readmissions, hospitalizations and emergency department visits, and costs. We will conduct key informant interviews to understand patient experience with the acre received during and after care transitions. By examining effectiveness of the intervention on outcomes including medication adherence, health care utilization, costs, and patient experience, this study will provide valuable results to health systems, payers, and policymakers to assist in future implementation and sustainability of the intervention for socioeconomically disadvantaged populations.

NCT ID: NCT06364124 Recruiting - STEMI Clinical Trials

Effects of PCSK-9 Inhibitor Treatment Prior to Undergoing Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction

Start date: June 1, 2023
Phase: Phase 4
Study type: Interventional

Acute ST-segment elevation myocardial infarction (STEMI) is a common manifestation of cardiovascular emergencies. Percutaneous coronary intervention (PCI) and guideline-recommended pharmacotherapy have reduced mortality rates associated with STEMI, but the incidence of recurrent ischemic events, particularly early ischemic events, remains high. Current research suggests that low-density lipoprotein cholesterol (LDL-C) levels not meeting guideline-recommended levels and inflammation are closely related to early recurrent ischemic events. Evolocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, rapidly and effectively reduces LDL-C levels and suppresses inflammation. Long-term use in patients with acute coronary syndromes can reverse atherosclerosis and improve prognosis. However, data on its use in STEMI patients are limited, particularly regarding the cardioprotective effects of preoperative administration of 420mg evolocumab subcutaneous injection. This study aims to evaluate the effects of administering evolocumab 420mg before emergency PCI on lipid profiles, inflammatory markers, myocardial injury, and short-term prognosis in STEMI patients through a single-center, randomized, open-label study. It aims to provide theoretical evidence for further reducing the risk of recurrent cardiovascular events in STEMI and identifying more optimized treatment strategies.

NCT ID: NCT06353594 Recruiting - Clinical trials for ST Elevation Myocardial Infarction

Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI

COPERNICAN
Start date: March 11, 2024
Phase: N/A
Study type: Interventional

The objective is to compare a reduced stent strategy based on drug-coated balloon (DCB) percutaneous coronary intervention (PCI) with conventional drug-eluting stent (DES) coronary revascularization in patients presenting with ST-segment myocardial infarction (STEMI). Randomization will be performed after successful culprit-lesion guidewire crossing and flow restoration. Random allocation in a 1:1 fashion to one of the following strategies: - Study group: reduced stent PCI strategy (DCB-based) - Control group: conventional PCI strategy (DES-based).

NCT ID: NCT06323811 Recruiting - Clinical trials for Takotsubo Cardiomyopathy

Comparison of Free-breathing 3D Quantitative Perfusion in Patients With MINOCA and MINOCA-mimics

COPE-CMR
Start date: June 15, 2023
Phase: N/A
Study type: Interventional

This clinical study examines patients presenting with acute myocardial infarction and no significant coronary artery disease on coronary angiography (MINOCA) and patients with MINOCA-mimics with advanced CMR. The present study aims to: - assess the microvascular function with a novel quantitative 3D myocardial perfusion imaging approach in the acute phase and post-convalescence - refine the role and diagnostic potential of advanced quantitative CMR imaging - assess the potential prognostic significance of microvascular dysfunction and epicardial adipose tissue on cardiovascular outcomes Participants will undergo advanced CMR imaging in the acute setting (within 10 days after event) and post convalescence (after 3 months).

NCT ID: NCT06318481 Recruiting - Clinical trials for Myocardial Infarction, Acute

TADCLOT- a Double Blind Randomized Controlled Trial

TADCLOT
Start date: February 15, 2024
Phase: Phase 3
Study type: Interventional

Compare the safety and efficacy of a twice-daily Clopidogrel regimen vs. Ticagrelor in reducing major adverse events in patients undergoing primary PCI in a double-blind randomized controlled trial.

NCT ID: NCT06303050 Recruiting - Clinical trials for Stroke, Cardiovascular

Additional Effects of Mental Imagery Along With Task Oriented Training on Kinesiophobia in Patients With Stroke

Start date: December 7, 2023
Phase: N/A
Study type: Interventional

The objective of this study to determine the effect of mental imagery and task oriented training on Kinesiophobia in stroke patients. And to determine the association of Kinesiophobia with gait and balance in stroke patients. Patients will be divided into experimental and control group. Randomized participants will be allocated into control and experimental group. The experimental group will receive 20 minutes of MI training followed by 25 minutes of TOT for a total of 45 minutes, 5 days per week for 6 weeks.

NCT ID: NCT06298513 Recruiting - Clinical trials for Acute Myocardial Infarction: Rehabilitation Phase

Autonomic and Metabolic Response to Cardiac Rehabilitation After Acute MI

RIABILITOMICA
Start date: May 2, 2023
Phase:
Study type: Observational

Ischemic heart disease remains the leading cause of death in the western world. The beneficial effects of cardiac rehabilitation on the evolution of ischemic heart disease are known, but the effects of rehabilitation on the metabolic processes of the patients are so far poorly understood. Metabolomics is the qualitative/quantitative analysis of the body's metabolic responses to pathophysiological stimuli or genetic alterations. Metabolic changes caused by physical activity have been demonstrated in obese and diabetic patients and in athletes. Aim of the study is to evaluate whether cardiac rehabilitation after a first myocardial infarction induces changes in the metabolic state of patients, and whether these changes may be related with changes in the usual risk factors (i.e. glyco-lipidic profile, natriuretic peptides, homocysteine).

NCT ID: NCT06286878 Recruiting - Diabetes Clinical Trials

Pleiotropic Effects of Dapagliflozin in Patients With Acute Coronary Syndromes

Start date: December 8, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Type 2 diabetes mellitus (T2DM) is one of the most important risk factors for atherosclerotic heart disease. Strategies focused solely on glycemic control have failed to demonstrate vascular events reduction in this population. On the other hand, new antidiabetic drugs recently have demonstrated significant decrease of cardiovascular mortality, raising the hypothesis that possible effects beyond glycemia control could explain this benefit. Aim: This study is intended to evaluate possible pleiothropic effects of dapaglifozin, a SGLT-2 (sodium glucose cotransporter 2) inhibitor, in individuals admitted with a diagnosis of Acute Myocardial Infarction (AMI). Methods: This is a prospective, randomized, double-blind, placebo controlled trial. Individuals presenting with AMI whithin the first seven days of evolution will be randomized to dapaglifozin or placebo. The investigators's goal is to analyze platelet aggregability 48 hours after randomization (primary endpoint), as well as glycemic control, cardiac biomarkers, corrected QT interval electrocardiographic analysis, autonomic modulation through spectral analysis of the RR interval and inflammatory biomarkers at inclusion and 30 days after starting study drug (secondary endpoints). Sample size calculation resulted in 80 individuals (40 per group). Expected results: This study will seek to aggregate new insights to the current knowledge about this new antidiabetic drug class. Previous randomized clinical trials have demonstrated that SGLT-2 inhibitors significantly reduced the composite endpoint of cardiovascular death, AMI or stroke, as well as Heart Failure (HF) hospitalization. Therefore, this study is supposed to clarify possible mechanisms that could explain these results aforementioned.

NCT ID: NCT06278519 Recruiting - Clinical trials for Myocardial Infarction

CARdiAc Mri and BiOLogical samplEs at the Acute Phase of a Myocardial Infarction (CARAMBOLE)

CARAMBOLE
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

ST-Segment Elevation Myocardial infarction (STEMI) corresponding to acute occlusion of cornary artery is the most severe ischemic myocardial disease and a leading cause of mortality of heart failure worldwide. Although acute mortality from STEMI has decreased over the last decades, the prognosis remains pejorative and difficult to anticipate. The best management of STEMI patients depends of predictive factors of clinical prognosis and justifies an active research of these factors, in particular the mechanisms leading to deleterious left ventricular remodeling, myocardial inflammation, reperfusion injury including the no-reflow phenomenon which is a major determinant of heart failure. Cohorts of consecutive STEMI patients, with a comprehensive assessment of clinical, biological and imaging parameters are needed to offer the basis for new hypothese for research or interventions and to precisely evaluate the quality of care provided. The main objective of this study is to identify new markers: clinical, biological and imaging, treatment response and prognosis after STEMI. Secondary objectives of the CARAMBOLE cohort are to establish a comprehensive clinical databse, completed with biological samples and imaging data, that can be used in the following areas: - Descriptive epidemiology of STEMI and myocardial reperfusion - Evaluation of the clinical implications of the realization of a cardiac MRI at the acute phase of STEMI (regarding no-reflow, LVEF, intra cardiac thrombi) - Treatments observatory: safety, efficacy, indication of treatments provided in real life compared to the treatments recommended, adherence to treatments, costs - Quality of life, personal, familial, social and professional consequences of myocardial infarction - Research of new diagnostic and prognosis biomarkers - Research projects (e.g risk of developping cgnitive disorders in patients with STEMI as compared to the general population) Participants will undergo: - a cardiac MRI at the acute phase of their STEMI (5 +/- 3 days) then at 1 year follow-up - biological samples including blood, urinary and feces samples, at the acute phase of their STEMI (from admission and up to 8 days) then at 1 year follow-up - questionnaire assessment regarding their quality of life, cognitive status,and socio-economic conditions at the acute phase and 1 year follow-up of their STEMI.