Clinical Research Directory

Safety and Efficacy of Very Short DAPT in Older Patients Undergoing PCI

The goal of this clinical trial is to learn if reducing the duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (short treatment regimen, stopping aspirin at day 7) is as safe and efficient as the standard DAPT duration (standard treatment regimen) in elderly patients ≥ 65 years. The main questions it aims to answer are: Does the reduction of the duration of DAPT reduces rates of bleeding without increasing the risk of cardiovascular events? Researchers will compare a short treatment by DAPT (7 days, followed by single antiplatelet therapy) to a standard treatment duration by DAPT (3 to 12 months) after successful percutaneous coronary intervention with ≥ 1 drug-eluting stent. Participants will: * Take aspirin for 7 days in one group or 3 to 12 months in another group * Be contacted by phone at 7 days, 14 days, 21 days, 30 days, 3 months, 6 months and 12 months after hospital discharge * Keep a diary of any bleeding or cardiovascular events occurring during the study period

A Clinical Trial To Investigate The Effect Of EA-230 On Hospital Length Of Stay In Patients With Coronary Artery Disease (CAD) Undergoing Coronary Artery Bypass Grafting (CABG) Surgery.

EA-230 is a new therapy that may help people recover faster and have fewer problems after bypass surgery. In an earlier clinical trial, participants who received EA-230 during Coronary Artery Bypass surgery stayed in the Intensive Care Unit (ICU) and the hospital for a shorter time and had fewer serious complications, compared to those who received a placebo (an inactive therapy). The use of EA-230 was safe and well tolerated. This trial will test EA-230 in more participants to see if it really works and is safe to use in the future. This is a Phase III trial. It will take place in multiple locations and will follow a double-blind, randomized, placebo-controlled clinical design, meaning neither doctors nor participants will know whether they receive EA-230 or placebo during the trial. Assignment to EA-230 or placebo occurs by chance, like throwing dice. The total duration of the trial, including medical check-ups, will be approximately 71 days. There is a total of 10 visits, including a screening-, a pre-operative-, and 2 remote visits. 7 of these visits are during your stay at the hospital.

Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI

Study Background \& Purpose: The no-reflow phenomenon is a significant complication occurring in patients with acute myocardial infarction who undergo percutaneous coronary intervention (PCI). It leads to poor myocardial perfusion despite successful opening of the culprit coronary artery. Sodium-glucose cotransporter 2 (SGLT2) inhibitors have demonstrated cardioprotective mechanisms beyond glucose control. Objective: This randomized controlled trial aims to evaluate the effectiveness and safety of administering SGLT2 inhibitors as adjunctive therapy in reducing the incidence of the no-reflow phenomenon in patients with myocardial infarction undergoing PCI. Study Plan: Eligible patients presenting with myocardial infarction scheduled for PCI will be randomized into three groups: one group receiving standard pharmacological care plus Empagliflozin therapy, second group receiving standard pharmacological care plus dapagliflozin therapy, and the control group receiving standard pharmacological care alone. Patients will be monitored during and after the procedure to evaluate coronary blood flow and incidence of no reflow phenomenon.

TRADENT Scoring Balloon Versus Non-scoring Balloon for Lesion Preparation in DCB-Based Coronary Intervention

This study will compare the effectiveness of the TRADENT™ coronary scoring balloon with a conventional non-scoring balloon for lesion preparation in patients undergoing a drug-coated balloon (DCB)-first percutaneous coronary intervention (PCI) strategy for de novo coronary lesions. The study will evaluate angiographic acute gain after lesion preparation and assess whether improved lesion preparation leads to a higher rate of successful drug-coated balloon (DCB)-alone treatment. The study is a prospective, multicenter, randomized, open-label, blinded-endpoint trial.

Coroflex® ISAR NEO PMCF Study

International, Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Coroflex® ISAR NEO coronary stent system to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Coroflex® ISAR NEO coronary stent system sirolimus eluting stent.

Fexuprazan for Prevention of Upper Gastrointestinal Bleeding in High Bleeding Risk Patients Receiving Dual Antiplatelet Therapy

This study evaluates whether fexuprazan is effective in preventing upper gastrointestinal bleeding and related upper gastrointestinal clinical events in high bleeding risk patients who require dual antiplatelet therapy after coronary stent implantation. A total of 200 participants at a single center will be randomly assigned in a 1:1 ratio within 48 hours after stent implantation to receive either fexuprazan 40 milligrams or lansoprazole 30 milligrams once daily for 6 months. The study will compare upper gastrointestinal clinical events during follow-up

Serum Endogenous Estrogens, Estrogen Receptors, and Sirtuin-1 and -3 After Resveratrol Supplementation

Atherosclerotic coronary artery disease (CAD) is a leading cause of mortality among postmenopausal women. Resveratrol, a phenolic compound with antioxidant properties, may influence lipid metabolism, endothelial function, and platelet aggregation, while sirtuin-1 and sirtuin-3 regulate metabolic and hormonal responses to nutritional stimuli. This randomized, double-blind, placebo-controlled trial evaluates the effects of trans-resveratrol supplementation (1000 mg/day) versus placebo, over 90 days, on serum estradiol and estrone levels, gene expression of estrogen receptors alpha and beta, and sirtuins 1 and 3 in 80 postmenopausal women with CAD. Findings may inform therapeutic strategies for postmenopausal women with chronic coronary disease.

1-Month Versus 6-Month Dual Antiplatelet Therapy After Successful Drug-Coated Balloon-Only Percutaneous Coronary Intervention

This study will compare the clinical outcomes of a 1-month dual antiplatelet therapy (DAPT) strategy with a standard 6-month DAPT strategy in patients undergoing successful drug-coated balloon-only percutaneous coronary intervention (DCB-only PCI). The study will evaluate net adverse clinical events (NACE) at 12 months to assess whether short-term 1-month DAPT is non-inferior to 6-month DAPT. The study is a prospective, randomized, open-label, blinded-endpoint, multicenter trial.

Predicting Plaque Growth Using Blood Flow Stress Markers: A Proof-of-Concept Study

Coronary artery disease occurs when fatty deposits (plaques) build up inside the arteries that supply blood to the heart. Some plaques remain stable, while others continue to grow or become more likely to rupture, which can lead to a heart attack. Identifying plaques that are at higher risk of progression could help doctors provide earlier and more personalized treatment. The purpose of this study is to determine whether combining information about blood flow within the coronary arteries with information about a person's biological response to blood flow can improve prediction of plaque growth. Participants undergoing treatment for coronary artery disease will have a specialized heart scan to assess blood flow patterns around plaques in their coronary arteries. Researchers will also collect blood samples to study cells that line blood vessels and investigate how these cells respond to blood flow forces. The study will follow participants over time to determine whether plaques are more likely to progress in individuals who show a stronger biological response to abnormal blood flow. The findings may help researchers develop new ways to identify patients at higher risk of future heart problems and support the development of more personalized approaches to prevention and treatment of coronary artery disease.

Identification of Lesion Characteristics in Coronary Plaques Using Multimodality Intravascular Imaging and Novel Photon-counting CT in Stable Angina

Coronary artery disease, caused by the furring up of the heart arteries by atherosclerosis, is a major cause of death in the UK. Despite existing therapies, adverse cardiovascular events remains high, especially in patients who have already had a heart attack, as some of these patients have aggressive atherosclerotic disease. If we could identify these vulnerable patients, then in wider clinical practice in the future we might be able to treat them better with new therapies that can otherwise be expensive or come with a risk of side-effects. Traditionally, the assessment of atherosclerotic disease and the identification of the plaques that will cause heart attacks is performed using invasive imaging - imaging taken by passing a wire into the arteries of the heart that has a camera on its tip. Invasive imaging, however, can be used only in patients with symptoms and has risks. Photon counting (PC) CT is a new CT system that has image quality comparable to invasive imaging and can be used in the community to examine individuals with stable angina symptoms. In this study we aim to compare how well PC-CT detects high-risk plaques compared with invasive imaging and in due course develop a platform that will expedite the analysis of CT images to allow its broad use in the clinical practice.

On vs Off-hour PPCI in STEMI Patients

ST-elevation myocardial infarction (STEMI) remains a leading cause of morbidity and mortality globally, and timely reperfusion with primary percutaneous coronary intervention (PPCI) is the gold-standard treatment1. Current guidelines recommend a door-to-balloon (DTB) time of 90 minutes or less, as the benefits of PPCI increase in direct correlation with the brevity of reperfusion time. However, there is consistent epidemiological evidence that STEMI patients presenting during off-hours (nights, weekends, and holidays) experience delays in reperfusion and worse in-hospital outcomes compared to those presenting during regular business hours. Two competing hypotheses dominate the literature. The systems hypothesis suggests that delays in care delivery during nights and weekends-including longer catheterization laboratory activation time, reduced availability of experienced operators, and logistical constraints-are the primary drivers of worse outcomes. In support of this, some studies have found that the mortality difference between off-hours and on-hours presentations is attenuated after adjusting for DTB time (Chung et al., 2020), suggesting that system-level process measures may be actionable targets for quality improvement. Alternatively, the intrinsic severity hypothesis suggests that nocturnal STEMI presentations represent inherently more severe infarcts-characterized by higher thrombus burden, larger myocardial infarction size, and more frequent complications such as cardiogenic shock-independent of how rapidly reperfusion is achieved. Recent studies examining circadian variation in infarct size and myocardial injury biomarkers have found evidence of larger infarcts and worse systolic function in nocturnal-onset STEMI, with long-term mortality implications. Critically, the vast majority of evidence in this field derives from retrospective registry data, particularly from North American and Western European cohorts. Data from the Middle East and North Africa (MENA) region, where demographic and healthcare system profiles differ substantially from developed nations, are essentially absent from the literature. Furthermore, contemporary data on the prospective relationships between time-of-PPCI, operator experience, procedural quality parameters (such as myocardial blush grade and ST-segment resolution), and outcomes remain limited. A prospective study with granular intra-procedural data collection offers the opportunity to: (1) quantify the magnitude of the off-hours effect in a Middle Eastern context; (2) decompose the DTB time into its components to identify specific system bottlenecks; (3) assess whether operator seniority and team composition confound or mediate the off-hours effect6; and (4) evaluate whether procedural quality metrics (reperfusion grade, thrombus burden, microvascular perfusion) differ between daytime and nighttime PPCI and contribute to outcome disparities independent of system factors.

Brazilian Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions

The objective is to evaluate the efficacy and safety of the Inspiron™ EVO drug-eluting stent in complex coronary lesions in a real-world population. Patients with symptomatic ischemic heart disease due to lesions in native coronary arteries and restenotic lesions will be treated with the Inspiron™ EVO drug-eluting stent.

Minicrush Versus Culotte Stenting in Complex Coronary Bifurcation Lesions:The Multicenter T-REX II Registry

Percutaneous coronary intervention (PCI) of complex coronary bifurcation lesions frequently requires an upfront two-stent strategy. While the double kissing crush technique has been extensively studied, limited contemporary data are available comparing alternative two-stent approaches, particularly Minicrush and T-stenting and Culotte, in complex bifurcation anatomy. This study aimed to compare procedural characteristics and long-term clinical outcomes of Minicrush versus Culotte stenting techniques in patients undergoing PCI for complex coronary bifurcation lesions.

"Discovery2" Study of Using MCG at Emergency Departments

The purpose of this research is to collect the magnetic signals from the heart to identify features that may help Emergency Department (ED) doctors differentiate high and low risk patients for heart related chest pain.

Mind-Body Interventions in Coronary Artery Disease

This randomized controlled study aims to evaluate the effects of a combined mind-body intervention consisting of progressive muscle relaxation and guided imagery on psychological outcomes in patients with stable coronary artery disease. A total of 40 participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive eight individualized sessions over four weeks in addition to standard medical care, while the control group will continue with standard care only. Primary and secondary outcomes will be assessed using validated self-report instruments, including the Perceived Stress Scale (PSS), Hospital Anxiety and Depression Scale (HADS), and COPE Inventory, administered at baseline and after the intervention period. The main objective of the study is to determine whether structured mind-body techniques can reduce perceived stress, anxiety, and depressive symptoms and improve coping strategies in patients with coronary artery disease.

EFFETCS OF MİNDFULNESS-BASED STRESS REDUCTION İN WOMEN WİTH CORONARY ARTERY DİSEASE

Coronary artery disease (CAD) is a common cardiovascular condition characterized by the narrowing or blockage of the coronary arteries that supply oxygen-rich blood to the heart muscle. CAD represents a significant cause of morbidity and mortality, particularly among individuals aged 40 and older, affecting millions of men and women worldwide. Patients with CAD experience not only physical symptoms but also psychological challenges, including stress and anxiety, which can negatively impact quality of life. In recent years, mindfulness-based interventions have emerged as scientifically supported approaches to help individuals with chronic diseases manage stress and enhance emotional regulation skills. While the existing literature includes studies evaluating the effects of mindfulness-based interventions in CAD and other cardiovascular conditions, most investigations address mixed patient populations and do not thoroughly examine sex-specific differences. Notably, women with CAD may experience symptoms and psychological effects differently than men. Therefore, there is a need for tailored, comprehensive intervention models that address the multidimensional needs of female patients, including stress management, anxiety reduction, and empowerment. This study aims to evaluate the effectiveness of mindfulness-based interventions in women with CAD, providing a targeted approach that addresses both clinical and psychosocial outcomes. The findings are expected to offer valuable insights into improving quality of life and enhancing coping strategies for women living with chronic cardiovascular disease.

Multivessel Minimally Invasive Coronary Bypass Grafting as HYBRID Revascularization Versus Conventional Off-pump Coronary Artery Bypass Grafting

The MICRA-HYBRID trial is a prospective, multicenter, randomized controlled study comparing multivessel hybrid coronary revascularization (HCR) as minimally invasive arterial bypass grafting to left-sided coronary targets (LAD and LCx) plus PCI of the RCA versus conventional off-pump coronary artery bypass grafting (OPCAB) via median sternotomy in patients with three-vessel coronary artery disease. The primary goal is to evaluate whether multivessel-HCR provides superior 30-day "textbook" clinical outcomes (mortality, MI, stroke, re-exploration for bleeding, and other complications) while improving perioperative recovery and long-term cardiovascular outcomes.

Ketamine-lidocaine Versus Ketamine-fentanyl for Induction of Anesthesia in Patients With Left Ventricular Systolic Dysfunction Undergoing Elective Coronary Artery Bypass

This study compares ketamine/fentanyl versus ketamine/lidocaine in term of their impact on cerebral perfusion during CABG. No prior data address these effects, and the goal is to identify the induction regimen that better preserves cerebral oxygenation.

Study on Risk Factors and Prognostic Value of Non-target Lesion Progression in Patients With Coronary Artery Disease

The goal of this observational study is to explore the risk factors and prognostic value of non-target coronary lesion progression in patients aged 18-80 years with established coronary artery disease who are scheduled for repeat coronary angiography. The main questions it aims to answer are: What clinical, inflammatory and metabolic factors are independently associated with the progression of untreated non-target lesions after percutaneous coronary intervention? Does the initial interventional strategy (drug-eluting stent vs. drug-coated balloon) influence the long-term progression of non-target coronary lesions and subsequent clinical outcomes? Researchers will compare participants treated with drug-eluting stents (DES) and those treated with drug-coated balloons (DCB) at their prior index procedure to see if different local interventional modalities lead to differences in non-target lesion progression and major adverse cardiovascular events during follow-up. Participants will: Undergo clinically indicated repeat coronary angiography, with offline quantitative coronary angiography (QCA) analysis of all coronary segments Provide baseline clinical data, medical history and blood samples for inflammatory and metabolic biomarker testing Complete 3 years of regular clinical follow-up to track lesion evolution and cardiovascular endpoints

Comparison of Upper and Lower Limb Maximal Exercise Capacities and Arterial Stiffness in Patients With CAD

Coronary artery disease (CAD) significantly increases mortality rates in both developed and developing countries. In this condition, the impairment of arterial blood circulation leads to insufficient blood supply to the myocardium during both rest and exercise, resulting in symptoms such as angina pectoris, dyspnea, and fatigue. Patients, particularly due to their fear of experiencing angina pectoris, tend to adopt a sedentary lifestyle. This situation contributes to exercise intolerance and a reduction in exercise capacity among individuals with CAD. A review of the literature reveals a lack of studies investigating upper and lower extremity exercise capacity and the physiological responses during exercise testing in patients with CAD. Therefore, the aim of this study is to compare arterial stiffness, muscle oxygenation, respiratory muscle fatigue, energy expenditure, perceived dyspnea, and fatigue during upper and lower extremity exercise testing in patients with coronary artery disease.

Clinical Study of Coronary Extension Catheter

This prospective, multicenter, single-arm study plans to enroll 69 subjects. Subjects meeting the protocol criteria will receive treatment with coronary extension catheters. The safety and efficacy of these catheters in percutaneous coronary intervention will be assessed through the collection and analysis of efficacy and safety endpoints during treatment and follow-up.

Health for Hungary (H4H) - Longitudinal Collection of Blood Samples and Corresponding Data

The Health for Hungary (H4H) study collects blood samples and corresponding health data to investigate healthy aging and health-to-disease transitions in middle-aged and elderly participants. Indications Studied: Apparently healthy, symptom-free participants are enrolled and followed up to study the onset of new-onset diseases with special emphasis on non-communicable diseases (NCDs). Study Design: Single-country, multicenter, prospective, longitudinal survey. Objectives: The study aims to establish reference ranges of blood parameters using routine clinical blood tests and high-information-content methods, including proteomics, metabolomics and the so-called infrared molecular fingerprinting. The study also aims to identify novel biomarkers of major non-communicable diseases, including atherosclerotic cardiovascular disease, cancer, diabetes and chronic respiratory disease.

The Effect of Cardiac Rehabilitation on Ferroptosis in Patients With Coronary Artery Disease

Coronary artery disease (CAD) remains a major global health concern and is the leading cause of cardiovascular mortality worldwide. Cardiac rehabilitation (CR) is a comprehensive, evidence-based intervention that integrates exercise training with optimal medical management and has been shown to improve clinical outcomes in patients with CAD. The primary objective of this study is to investigate the effects of cardiac rehabilitation on ferroptosis, an iron-dependent form of regulated cell death, in patients with coronary artery disease. A total of 90 participants will be enrolled in the study after providing written informed consent. The study population will consist of three groups: 30 patients with CAD who participate in a cardiac rehabilitation program, 30 patients with CAD who voluntarily decline participation in cardiac rehabilitation, and 30 age- and sex-matched healthy volunteers without any known chronic disease. Peripheral venous blood samples will be collected from patients undergoing cardiac rehabilitation both before the initiation of the rehabilitation program and upon its completion. A single blood sample will be obtained from patients who decline participation in cardiac rehabilitation and from healthy control participants. To evaluate ferroptosis-related molecular alterations, the expression levels of the ferroptosis-associated genes GPX4, SLC7A11, ACSL4, FSP1, NRF2, TFRC, and NCOA4 will be analyzed. In addition, serum concentrations of ferroptosis-related biomarkers, including free iron, 4-hydroxynonenal (4-HNE), malondialdehyde (MDA), and GPX4 protein, will be measured. The molecular and biochemical parameters will be compared among the three study groups, and changes in ferroptosis-related biomarkers before and after the cardiac rehabilitation program will be evaluated in patients undergoing cardiac rehabilitation.

BASel Kosten-Effektivitäts-Trial: Drug-coated BALLoon (DCB) vs. Drug-eluting Stent (DES) Strategy in High-risk Patients With Coronary Artery Disease (CAD)

The main objective of this randomized, multicenter, international, open-label clinical trial is to demonstrate that, in the context of percutaneous coronary intervention for complex coronary artery disease, a SeQuent® SCB interventional strategy is non-inferior to a new-generation DES strategy in terms of a 12- and 36-month composite of Target Vessel Failure (TVF), that includes: * cardiovascular death (CV death), * target vessel related MI (TV-MI), * clinically indicated target vessel revascularization (ci-TVR), * bleeding according to Bleeding Academic Research Consortium (BARC) Types 3-5. Eligible subjects will be assigned in a 1:1 ratio to receive treatment of all lesions with either the SeQuent® SCB-based strategy or a DES-based strategy. The randomization will be performed prior to the index procedure once signed informed consent has been obtained and all eligibility criteria have been confirmed. All Subjects will be followed for clinical outcomes at 3 months, 1, 2, and 3 years. A subset of 138 randomized patients will undergo control angiography after one-year clinical follow-up (+1 month). An independent core laboratory will analyze all baseline angiograms. If, at 36 months, the non-inferiority of the SeQuent® SCB strategy compared to the DES strategy is achieved, superiority in terms of TVF and BARC Type 3-5 bleeding will be tested. An optional extension of follow-up to 6 years may be implemented based on interim results and the joint decision of the Steering Committee and the Sponsor. Details regarding this optional extension are provided in the Clinical Investigation Plan.