Clinical Research Directory

Evaluation of a Remote Behavioural Stress Recovery Intervention for Myocardial Infarction Patients Younger Than Fifty-five (BRIM-55): A Feasibility Study

The goal of this feasibility study is to learn if the randomised controlled trial evaluating the Remote-delivery Balance in Everyday Life (rBEL) programme for adults younger than 55 years who have experienced a myocardial infarction (MI), is feasible. The objective is to examine the feasibility of the rBEL programme and the associated study procedures before a controlled evaluation of the programme. This is an uncontrolled, single-arm, pre-post treatment designed study. Participants of the target population will take part of the six session over 13 week programme. Feasibility will be evaluated against predefined feasibility criteria regarding study procedures and programme acceptability.

Individualized Discharge Education in High-Risk Myocardial Infarction Patients

The purpose of this clinical study is to evaluate whether individualized discharge education is effective in treating patients identified as high-risk based on the LACE index after a myocardial infarction. Additionally, information will be gathered regarding the safety and outcomes of this education. The key questions the study aims to answer are: Does individualized discharge education reduce hospital readmission rates for patients identified as high-risk after a myocardial infarction? Does this education improve patients' treatment adherence, self-care levels, and quality of life? Researchers will compare the effectiveness of individualized discharge education against routine care. Participants will:Receive individualized discharge education prior to discharge if they meet the high-risk criteria, and receive a comprehensive educational brochure. Be followed up via telephone three days a week while at home to monitor their care practices and hospital visits. Participate in follow-up assessments at the 1st month (Follow-up 1) and 3rd month (Follow-up 3) to complete the Coronary Heart Disease Self-Care Inventory and the HeartQoL scale.

Senescence in Myocardial Infarction

The investigators of this study have found that after a heart attack, some heart cells rapidly age (become senescent) and release proteins that make the heart disease worse. The investigators of this study would like to check for these aged-cell proteins in participants who have coronary artery bypass graft (CABG) surgery after a recent heart attack or to treat more stable heart disease. The investigators will do this by taking blood samples and a sample of normally discarded heart tissue from each group of participants. This might help tell us who is at the highest risk of developing heart disease and how people recover from a heart attack.

Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction

This study is open to adults with ST elevation myocardial infarction (heart attack) undergoing primary percutaneous coronary intervention (PCI). The purpose of this study is to determine whether a medicine called Xolatryp is safe and effective in improving cardiac outcomes. One dose of Xolatryp will be tested in this study. Participants are put into two groups randomly, which means by chance. One group receives a single 6-hour continuous intravenous infusion of Xolatryp and one group receives placebo. Participants are in the study for about 30 days. Placebo infusion looks like Xolatryp but do not contain any medicine. Participants are followed up via telephone and there is one visit to the study site on day 30. Heart health is assessed based on the analysis of blood samples, which are collected at the study site, via electrocardiogram (ECG), echocardiogram and cardiac magnetic resonance (CMR) imaging. At the end of the study, the results are compared between the two groups. During the study, the doctors also regularly check the general health of the participants.

Sixth Generation High-sensitivity Cardiac Troponin T for the Early Rule Out of Myocardial Infarction: a Controlled Before and After Study

Cardiac troponin is a protein released into the blood when the heart muscle is damaged. Measuring this protein helps doctors diagnose a heart attack (also called a myocardial infarction). Modern blood tests, known as high-sensitivity cardiac troponin assays, can detect very small amounts of this protein. A new version of this test, called Troponin T high-sensitivity Gen 6, has recently been developed and approved for use. It is designed to be more accurate and reliable, detecting smaller changes in troponin levels and being less affected by technical interference. The investigators believe this improved test will allow doctors to diagnose heart attacks more quickly and decide sooner who needs to stay in hospital and who can safely go home. This could help reduce overcrowding in Accident and Emergency (A\&E) departments, a major challenge for the NHS. This study will examine whether switching to this new test across a health board shortens the time patients with suspected heart attacks spend in the Emergency Department. The investigators will use information from the DataLoch Heart Disease Registry, which automatically collects anonymised hospital data for patients attending with possible heart attacks. The investigators will compare data from one year before and one year after implementation to see whether average length of stay changes and to confirm that patient safety remains high. This investigators will also measure both the current and new versions of the troponin test in surplus blood samples collected during two six-month periods-one before and one after the new test is introduced. This will allows the investigators to directly compare the two tests reliably. Patients will not need to do anything extra to take part - the study uses information and samples already collected as part of their usual care.

Remote Exercise SWEDEHEART Study

The overall aim of the study is to evaluate if remote video exercise-based cardiac rehabilitation (exCR), offered as an alternative to centre-based exCR, can increase participation in exCR sessions post myocardial infarction (MI).

Polyamine Treatment in Elderly Patients With Coronary Artery Disease

The present study is testing spermidine treatment in elderly patients with coronary artery disease. The study is a randomized, double-blind, placebo-controlled, two-armed, parallel-group, single centre, clinical study.

Transcultural Digital Solutions in Phase III Cardiac Rehabilitation

Multicenter Prospective Controlled Randomized Trial, open-label, in patients with atherosclerotic cardiovascular disease (ASCVD) (acute coronary syndrome or chronic coronary syndrome and ischemic heart failure) and an approved indication for cardiac rehabilitation (CR). Patients completing phase II CR will be randomized 1:1 to usual Phase-III care (standard care) versus standard care plus the Digitally-Enhanced Extended PrEvention \& Rehabilitation (DEEPER) package (intervention). Primary outcome is 6-month change in composite Life's Crucial 9 (LC9) (LE8 + PHQ-9).

Intramyocardial Haemorrhage in Patients With Primary STEMI

The purpose of the study is to assess the frequency and intensity of intramyocardial haemorrhage in patients with primary STEMI and different reperfusion strategies.

Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy

The primary aim of this study is to evaluate the efficacy and safety of novel P-CAB (tegoprazan 50 mg once daily) as compared with standard PPI (rabeprazole 20 mg once daily) for protection of GI events in patients with known cardiac and vascular disease receiving chronic use of antithrombotic drugs (either antiplatelets, OAC, and its combinations) who are at high GI bleeding risk. The primary hypothesis is that P-CAB (experimental arm) would non-inferior to PPI (standard arm) with respect to the rate of the primary composite end point of GI events at 12 months after randomization.

IRI-EXPLORE: A Study to Test Whether BI 765845 Helps People Who Have Had a Heart Attack

This study is open to adults aged 18 and over who have just had a heart attack. The purpose of this study is to find out whether a medicine called BI 765845 helps people who have had a heart attack. The investigators also want to test how well different doses of BI 765845 work and how they are tolerated by people who have had a heart attack. Participants are randomly assigned to receive either BI 765845 or placebo. Placebo treatments look like BI 765845 treatments but do not contain any medicine. Participants are about 3 times as likely to receive BI 765845 than placebo. Participants are in the study for 3 months. During this time, they visit the study site 7 times and get 3 phone calls from the site staff. At the visits, the doctors use clinical tests to check the health of the heart. The results are compared between the BI 765845 and placebo groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Safety and Efficacy Study of Adjunctive Antiplatelet Therapy Prior to Primary PCI in Patients With STEMI

Safety and efficacy of adjunctive antiplatelet therapy prior to primary percutaneous intervention (PCI) in patients with ST-Elevation Myocardial Infarction (STEMI)

Polymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes

POLARIS is a prospective, single-centre, single-arm observational pilot registry evaluating the real-world safety and efficacy of the Focus np (Abluminus np, Concept Medical, Tampa, FL, USA) polymer-free sirolimus-eluting stent in consecutive adult patients undergoing percutaneous coronary intervention (PCI). The primary endpoint is target lesion failure (TLF) at 12 months, defined per Academic Research Consortium-2 (ARC-2) criteria as the device-oriented composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation. Patients treated since January 2021 will be retrospectively identified and prospectively consented, with follow-up through 5 years. The registry will provide the first Western clinical evidence on this CE-marked device and serve as a template for a future national Swiss multicentre registry.

Educational Dietary Intervention in Early Cardiac Rehabilitation After Myocardial Infarction

The trial is designed to assess whether individualized nutritional education provides additional benefit beyond standard early cardiac rehabilitation in patients after myocardial infarction. Patients referred for cardiac rehabilitation after myocardial infarction are randomized to a control group receiving standard rehabilitation care or to an intervention group receiving standard care plus structured personalized dietary education. The educational intervention is tailored to baseline dietary habits, nutritional knowledge, and adherence to cardioprotective dietary recommendations. Outcomes include changes in diet quality, adherence to the Mediterranean diet, nutritional knowledge, anthropometric measures, and bioelectrical impedance analysis-derived body composition parameters. The study will evaluate the feasibility and effectiveness of integrating individualized dietary education into early cardiac rehabilitation after myocardial infarction.

A Study to Evaluate the Impact of Long-term Digital Education vs Standard of Care on LDL-C Levels in Post Myocardial Infarction Patients

The purpose of this study was to demonstrate the impact of digital education on the cardiovascular risk factors in post-Myocardial Infarction patients and to generate evidence for broad implementation of the proposed education program.

Machine Learning for Diagnosis of Occlusive MI in LBBB Patients

This study investigates a new way to diagnose severe heart attacks in patients who have a specific electrical heart pattern called a Left Bundle Branch Block (LBBB). When patients present to the emergency department with chest pain, doctors routinely perform an electrocardiogram (ECG) to check for a heart attack. However, the presence of an LBBB can alter the heart's electrical signals on the ECG, effectively masking or hiding the typical signs of an ongoing acute coronary occlusion (a completely blocked artery). This making it highly challenging for emergency physicians to make an accurate and rapid diagnosis. The primary purpose of this prospective and observational research is to develop and evaluate an artificial intelligence/machine learning (ML) model that can analyze digital 12-lead ECG signals to accurately predict a true blocked coronary artery in patients with LBBB. The machine learning model will analyze raw digital ECG waveforms to detect subtle, microscopic patterns that might be missed by the human eye. To confirm the accuracy of the model, its predictions will be compared directly with invasive coronary angiography results, which is the gold standard reference method used to visualize blocked vessels. Additionally, the study aims to evaluate if the model can differentiate between a true heart attack caused by a blocked artery (Type 1 MI) and other non-occlusive conditions that cause elevated heart enzymes (Type 2 MI). Ultimately, the investigators intend to determine whether integrating this machine learning tool into emergency care can safely reduce the rate of unnecessary emergency invasive procedures for patients who do not have a true coronary blockage.

A Genomic Approach for Clopidogrel in Caribbean Hispanics

Clopidogrel is a prescription medicine used to minimize blood clot formation in patients with cardiovascular disease, particularly those undergoing heart catheterization and stroke. A substantial amount of medical evidence has proven that patients with stroke or heart diseases can benefit from this medicine. However, significant variability in such expected benefits has been found among individuals receiving clopidogrel, with some patients not having the benefit of reduced complications and adverse cardiovascular events. Prior studies have demonstrated a significant association between certain variants on patient's genes (e.g., CYP2C19) and poor response to clopidogrel and, therefore, major adverse cardiovascular events. Variation in other genes and other factors such as platelet activation, weight, diabetes mellitus (a medical condition that produces high blood sugar), concomitant use of other drugs, and smoking status have also been proposed to be related to the same adverse outcomes. In this study, the investigators would like to determine a possible association between these genes and the response to the medication among Caribbean Hispanic cardiovascular patients on clopidogrel. In other populations, it is known that patients with certain genetic variants have lower or magnified responses to this medication when compared to those individuals taking the same dose and not carrying the genetic variations. However, a fundamental gap remains in understanding whether the genomic diversity of Caribbean Hispanics accounts for the observed high inter-individual variability of clinical outcomes to preventive dual antiplatelet therapy (DAPT) with clopidogrel.

Changes in Regional and Global Cardiac Contractility After Stimulation in Scar Zone With the NOGA System

Despite a decrease in voltage amplitude in post-infarction scar areas, greater voltage amplitudes are sometimes observed at the time of local extrasystoles mechanically induced by catheters. However, no study has investigated whether these electrical changes are associated with mechanical changes in local contractility. However, the voltage is closely correlated to the local contractile function as evidenced by the use of the NOGA system.

Impact of a Therapeutic Education Program of Patient on the Evolution of the Cardiovascular Chronic Disease

The Exploration Center for Prevention and Treatment of Atherosclerosis (CEPTA, Bordeaux Hospital University) showed that following myocardial infarct (MI) or ischemic stroke (TIA or stroke), the global management (medical and educational) of patients led to very long-term satisfactory results in terms of reduction of cardiovascular (CV) risk and morbidity and mortality. However, the specific effect of therapeutic education beyond the conventional treatment has never been an adequate assessment. The following at 1 year of this study will show the evolution of chronic long-term CV disease in patients who received therapeutic education, and to explain the mechanisms. The challenge of this project is to demonstrate for the first time the superiority of therapeutic education and conventional care and propose a modeling program for national diffusion. Patients who experienced a CV event (MI, stroke) will be randomized into 2 groups of 165 patients each: 1) receiving conventional treatment alone; 2) receiving conventional treatment + CEPTA program. The study was built for a 1-year follow-up period, to demonstrate the impact of therapeutic education on evolution of risk factors, physical, psychological and social health of patients. The main benefit of this study for the patient is the implementation of an optimized treatment and long-term monitoring by a cardiology referral center.

AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor

This prospective, multicenter, cluster-randomized controlled study aims to evaluate the accuracy of an investigational artificial intelligence (AI) Software as a Medical Device (SaMD) designed to compute ejection fraction (EF) severity categories based on the American Society of Echocardiography's (ASE) 4-category scale. The software analyzes continuous ECG waveform data acquired by the FDA-cleared Peerbridge COR® ECG Wearable Monitor, an ambulatory patch device designed for use during daily activities. The AI software assists clinicians in cardiac evaluations by estimating EF severity, which reflects how well the heart pumps blood. In this study, EF severity determination will be made using 5-minute ECG recordings collected during a 15-minute resting period with participants seated upright. The results will be compared to EF severity obtained from an FDA-cleared, non-contrast transthoracic echocardiogram (TTE) predicate device. This comparison aims to validate the accuracy of the AI software.

Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures, Third Wave

The CLIMATE-III Observational Study examines to what extent chronically ill patients experience adverse health effects because of heat and whether the patients' specific health behavior, somatosensory amplification, risk and benefit perception, self-efficacy, health literacy, and the degree of urbanisation of the patients' administration district are associated with these effects. Study participants from Germany and Italy will be included in the sample.

Cohort of STEMI Patients 2

ST-segment elevation myocardial infarction (STEMI) is an acute condition that accounts for 75% of sudden deaths in adults over 35 years of age and more than half of all cases of chronic heart failure. However, the mechanism of myocardial infarction remains poorly understood. At present, there is no national information system for myocardial infarction, as there is for other diseases such as multiple sclerosis (OFSEP cohort). The purpose of this cohort is to enable studies and research projects to be carried out on the descriptive epidemiology of myocardial infarction, monitoring of patients undergoing treatment (safety, efficacy), quality of life and functional consequences of infarction, and research into new biological and imaging prognostic biomarkers. Its general objective is to provide researchers, hospital practitioners, medical interns, academics or industrialists with a quality epidemiological tool for research.

Women's Health Initiative Strong and Healthy Study

The WHISH trial applies state-of-the science behavioral principles and currently available technologies to deliver a physical activity intervention without face-to-face contact to \~25,000 older U.S. women expected to consent. It includes the National Institute of Aging (NIA) Go4Life® Exercise \& Physical Activity materials 3 and WHISH developed targeted materials based on Go4Life® to provide inspirational tips and recommendations about how to achieve nationally recommended levels of PA and overcome barriers to exercise, with a means for self-monitoring and setting personal goals. The intervention builds upon evidence-based behavioral science principles and intervention components that have proven to be effective in increasing PA in older women, with innovative adaptive approaches to tailoring the delivery to meet individual (personal) needs.

Coronary Microvascular Dysfunction Assessments in Myocardial Infarction With Non-Obstructive Coronary Arteries

To compare clinical outcomes of myocardial infarction with non-obstructive coronary arteries (MINOCA) according to the coronary microvascular dysfunction (CMD), evaluated by optical coherence tomography (OCT), invasive and non-invasive coronary physiologic assessment.