Clinical Research Directory

Flecainide Safety in Patients With Coronary Artery Disease and Atrial Fibrillation

The goal of this clinical trial is to learn whether the antiarrhythmic drug flecainide can be used as safely as standard rhythm-control drugs in people with atrial fibrillation (AF) and stable coronary artery disease (CAD). The study includes adults aged 18 years and older who have AF and known but stable coronary artery disease. The main questions this study aims to answer are: * Is treatment with flecainide as safe as standard rhythm-control drugs (sotalol or amiodarone) in this patient group? * Does flecainide lead to similar or fewer serious side effects, hospitalisations, or deaths compared with standard treatment? Researchers will compare patients treated with flecainide to patients treated with standard rhythm-control therapy (sotalol or amiodarone) to see whether flecainide is not worse in terms of safety outcomes. Participants will: * Be randomly assigned to receive either flecainide or standard rhythm-control medication * Take the assigned medication as part of routine clinical care * Attend regular follow-up visits at the hospital and have additional follow-up by telephone * Undergo routine heart tests such as electrocardiograms and echocardiography * Complete questionnaires about symptoms, quality of life, and daily functioning This study follows patients for at least one year and collects information on safety, heart rhythm outcomes, quality of life, and healthcare use.

Prevent Cardiac Surgery Associated AKI Trial

Prevent CSA-AKI (Cardiac Surgery Associated Acute Kidney Injury) trial is a double blinded randomized controlled trial, 242 patients undergoing elective cardiopulmonary bypass surgery (CPB)will either receive a placebo or daily 1200 mg of Co enzyme Q10 (CoQ10) and 1000 mg of Glutathione (GSH), the first dose will be given the day before surgery and continues while admitted up to 1 week. Blood and urine samples will be collected. Adverse events related to the study drugs will be collected.

Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease (FRACTURE)

The FRACTURE Trial is a prospective, non-randomized, single-arm, multicenter, interventional study in US and international centers.

Quantitative Myocardial Perfusion Imaging Assessment by SPECT/CT

Myocardial perfusion single-photon emission computed tomography (SPECT) is a well-established functional imaging technique for the assessment of coronary artery disease. Recent developments in cadmium-zinc-telluride (CZT) camera technology have enabled significant reductions in acquisition time while improving image quality. Positron emission tomography (PET) myocardial imaging remains the reference standard for the quantitative assessment of myocardial blood flow (MBF) and myocardial flow reserve (MFR); however, its use is limited by high costs and restricted availability. This exploratory study aims to evaluate the feasibility of using CZT-SPECT/CT imaging as an alternative approach by assessing the absolute quantification of myocardial tracer uptake, expressed as standardized uptake values (SUV), both at rest and during stress. The primary objective is to compare the ratio of stress-to-rest SUV obtained from SPECT with MFR values measured using PET imaging. Patients under cardiology care at the University Hospital of Orléans who are scheduled for diagnostic coronary angiography or coronary CT angiography will be invited to participate. The study procedures will be integrated into their routine clinical workflow. On Day 0, participants will undergo a PET myocardial perfusion study using Rubidium-82, including measurement of MBF and MFR, with concomitant administration of 99mTc-tetrofosmin under pharmacological stress using the same vasodilator agent. A stress CZT-SPECT/CT acquisition will then be performed immediately after the PET scan. Within seven days of the initial evaluation, participants will undergo a rest CZT-SPECT/CT acquisition. Quantitative analysis of myocardial tracer uptake will subsequently be performed to derive SUV values. The overall goal of this feasibility study is to generate preliminary data to support the design of a larger-scale clinical study. Ultimately, the study seeks to determine whether standard CZT-SPECT/CT imaging could provide a simpler, faster, and more widely accessible alternative to PET myocardial perfusion imaging for functional myocardial assessment.

CABG or PCI in Patients With Ischemic Cardiomyopathy

The STICH-SWEDEHEART trial will compare PCI vs CABG for revascularization of patients with HF and LV systolic dysfunction (LV ejection fraction (LVEF) \<40%) and multi-vessel coronary artery disease.

Association Between Intraoperative Pulse Pressure Variation and Postoperative Lactate Clearance in Cardiac Surgery

This study aims to evaluate the relationship between intraoperative pulse pressure variation (PPV) and postoperative lactate clearance in adult patients undergoing elective cardiac surgery. Intraoperative PPV values will be recorded, and blood lactate levels will be measured at admission to the intensive care unit and at 6 and 12 hours postoperatively. The study will investigate whether intraoperative PPV is associated with postoperative lactate clearance. This is a prospective observational study, and no additional interventions will be performed beyond routine clinical care.

Dynamic Arterial Elastance for Prediction of Vasopressor Requirement After Anesthesia Induction in Elective On-Pump CABG

This study aims to determine whether dynamic arterial elastance (EaDyn), measured after anesthesia induction, can predict the need for vasopressor treatment in patients undergoing elective on-pump coronary artery bypass graft surgery. EaDyn will be calculated from pulse pressure variation and stroke volume variation. Hemodynamic measurements will be recorded before anesthesia induction and at 1, 3, and 5 minutes after induction. The study is prospective and observational, and no additional intervention will be performed as part of the study.

TOP-CABG Trial: Follow-up Extension (TOP-CABG FE)

To further evaluate the long-term effects of the two antiplatelet strategies on saphenous vein graft patency, long-term adverse cardiovascular events, and bleeding events after coronary artery bypass grafting (CABG), we plan to conduct an extended follow-up study based on the previously completed TOP-CABG trial. This extended follow-up aims to provide high-quality evidence to inform more optimized and individualized long-term antiplatelet management strategies for patients after CABG.

Efficacy and Safety of the Angionix Balloon in Patients With Coronary Artery Disease Undergoing PTCA

A Multi-center, Registry evaluating the efficacy and safety of the use of Angionix Balloon in Patient with Coronary Artery Disease

Influencing Factors and Outcomes of DCB Angioplasty

This ambiprospective observational study evaluates the long-term safety and efficacy of Paclitaxel Drug-Coated Balloon (DCB) angioplasty in approximately 20,000 patients withcoronary artery lesions in large vessels. By combining retrospective historical data with a prospective registry involving biological specimen collection, the study aims to identify key predictors of outcomes, including intravascular imaging findings, hemodynamic parameters, and biological markers. Patients will be followed longitudinally for up to 10 years to assess the durability of the treatment and the incidence of major adverse cardiovascular events (MACE).

IonMAN II Trial- Early Feasibility Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System

This is a prospective, multi-center, single-arm, open-label, early feasibility study to provide preliminary evidence for the safety and efficacy of the novel IoNIR stent system

ANGiographic Evaluation of Left Main Coronary Artery INtErvention

To assess if an angiographic follow-up at 6 months after Percutaneous Coronary Intervention in Left Main Coronary Artery Disease decrease the composite objective of death, myocardial infarction, and stroke at 36 months.

Intravascular Lithotripsy With or Without Rotational Atherectomy for Coronary Calcified Nodule Treatment

The NODULE-SHOCK trial is a prospective, investigator-initiated, single-center, randomized controlled trial designed to compare the efficacy of intravascular lithotripsy (IVL) with or without rotational atherectomy (RA) in patients with coronary calcified nodules (Cohort A), and operator-determined vs maximum IVL pulses in patients with non-nodular severe coronary calcium (Cohort B).

Gangwon PCI Prospective Registry

This prospective, multicenter registry will consecutively enroll patients of all ages undergoing percutaneous coronary intervention (PCI) at four university hospitals in Gangwon Province, Republic of Korea. The study will describe contemporary clinical, procedural, and medication treatment patterns and assess 1-year clinical outcomes in routine practice. The primary outcome is patient-oriented composite outcome (POCO), defined as all-cause death, any myocardial infarction, or any repeat revascularization. No study-specific intervention will be assigned.

CAPRA-EVO: a Randomized Serial PCCT Trial of Early Evolocumab After ACS

The CAPRA-EVO trial is a single-center, randomized, open-label study with blinded endpoint assessment comparing early evolocumab plus standard lipid-lowering therapy versus standard-of-care lipid-lowering therapy in patients with acute coronary syndrome after successful percutaneous coronary intervention. The study will use serial photon-counting coronary computed tomography angiography at baseline and 52 weeks to assess changes in non-culprit coronary plaque burden and stenosis severity. Secondary outcomes include changes in high-risk plaque features, lipid and inflammatory biomarkers, cardiovascular events, and safety outcomes. The trial aims to determine whether early intensive LDL-C lowering with evolocumab can reduce coronary plaque progression and support PCCT-CCTA as a noninvasive tool for monitoring atherosclerotic plaque dynamics.

Noninferiority Trial Of Sirolimus With Ascorbic Acid Versus Everolimus in All-comers

The objective of this study is to demonstrate the primary hypothesis that, in patients with chronic and acute coronary syndromes requiring percutaneous coronary intervention (PCI), the novel sirolimus-ascorbic acid eluting stent (D+Storm Novonix) is non-inferior to the standard treatment, the everolimus-eluting stent (Synergy XD), with respect to the incidence of target lesion failure (TLF) at 1 year after treatment, where TLF is defined as a composite of cardiovascular death, target vessel myocardial infarction, and clinically driven target-lesion revascularization.

Comparison of the Amplatzer Amulet Versus LAmbre Device for Left Atrial Appendage Closure

Clinical investigation with CE-marked medical devices, multicenter, prospective, randomized and controlled. Patients with non-valvular atrial fibrillation at high embolic risk and with at least one high bleeding risk criterion according to the Munich consensus document will be randomized to left atrial appendage closure with either the Amplatzer Amulet™ or the LAmbre™ device. The study is designed to compare the efficacy and safety of both devices regarding successful implantation, effective appendage closure, and clinical outcomes at follow-up.

Comparison of Moderate-Intensity Statin Plus Ezetimibe vs. High-Intensity Statin for Coronary Plaque Stabilization

This study is a prospective, multicenter, randomized clinical trial aimed at comparing the effects of moderate-intensity statin plus ezetimibe combination therapy versus high-intensity statin monotherapy on coronary plaque stabilization. Using advanced imaging techniques such as near-infrared spectroscopy-intravascular ultrasound (NIRS-IVUS), the trial evaluates whether the combination therapy is non-inferior to monotherapy in stabilizing coronary plaques over 52 weeks. The primary endpoint is the change in percent atheroma volume (PAV) from baseline to week 52, assessed by grayscale IVUS. Secondary outcomes include changes in lipid core burden, inflammatory markers, and clinical events like myocardial infarction and ischemic stroke. Seven hospitals participated in the study. A total of 408 participants were enrolled at six sites; no participants were enrolled at Inje University Ilsan Paik Hospital. Follow-up is ongoing.

The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)

The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy (STICH3C) trial is a prospective, unblinded, international multi-center randomized trial of 754 subjects enrolled in approximately 45 centers comparing revascularization by percutaneous coronary intervention (PCI) vs. coronary artery bypass grafting (CABG) in patients with multivessel/left main (LM) coronary artery disease (CAD) and reduced left ventricular ejection fraction (LVEF). The primary objective is to determine whether CABG compared to PCI is associated with a reduction in all-cause death, stroke, spontaneous myocardial infarction (MI), urgent repeat revascularization (RR), or heart failure (HF) readmission over a median follow-up of 5 years in patients with multivessel/LM CAD and ischemic left ventricular dysfunction (iLVSD). Eligible patients are considered by the local Heart Team appropriate and amenable for non-emergent revascularization by both modes of revascularization. The secondary objectives are to describe the early risks of both procedures, and a comprehensive set of patient-reported outcomes longitudinally.

Ultrastructural Characteristics of Mitochondria in Cardiomyocytes in Heart Failure

According to modern concepts, mitochondrial dysfunction may be the fundamental basis for the development and progression of CHF, including in patients undergoing myocardial revascularization. The processes of mitochondrial fusion, division and mitophagy are aimed at maintaining cellular homeostasis. A change in the balance of these processes can lead to the accumulation of damaged organelles with impaired functions. In patients with CHF, dysfunctional mitochondria are characterized by size dispersion, crist disorganization, and localization changes relative to myofibrils. At the same time, the topic of the influence of mitochondrial dysfunction on the prognosis and clinical course of CHF remains debatable today. Direct study of the structural and functional features of mitochondria in human cardiomyocytes is an extremely difficult task, and therefore, such studies are carried out extremely rarely and on very limited cohorts. In the planned study, due to the long time of the study material recruitment, the ultrastructure of mitochondria in a large cohort of patients, ranging from 45 to 60 people, will be studied. The aim of this study is to study the association of mitochondrial dysfunction with the clinical course and outcomes of CHF of ischemic etiology, as well as to assess the degree of compliance of indirect criteria of mitochondrial dysfunction with direct ultrastructural characteristics of mitochondria in cardiomyocytes. This single-center prospective cohort study will involve 45-60 patients. The patients will have biopsy samples taken from the right auricle, as well as blood collection and preservation and its derivatives. Electron microscopy of myocardial samples will be performed to assess the ultrastructure of mitochondria of cardiomyocytes. The results of a direct study of mitochondria will be compared with indirect signs of mitochondrial dysfunction: the registration of the phenomenon of increased leaching of radiopharmaceuticals from the myocardium, an increase in the number of copies of mitochondrial DNA and the concentration of cytochrome C in the blood, the affiliation of mitochondrial DNA to haplogroup K. The results obtained in each of the research tasks will have high scientific significance and publication potential.

Exercise Testing Protocols for Females and Males With CAD

The aim of this study is to determine if the test that allows males to achieve a higher VO2 (a measure of oxygen use during exercise) is different for females. The purpose of this study is to test 4 different exercise testing protocols to compare measured oxygen consumption in females and males with CAD (disease caused by the buildup of plaque in the artery walls which can lead to insufficient amounts of blood, nutrients and oxygen being supplied to the heart). The 4 exercise tests that will be completed on the treadmill are the modified Balke, modified Bruce, modified Naughton and University of Ottawa Heart Institute Slow Ramp protocols. Each test has a different stage duration (the amount of time that the test remains at a pre-determined speed and incline), and incremental increase in speed and incline. The main purpose of this study is to compare VO2 peak (the maximal amount of oxygen utilized during the exercise test) of females and males with CAD in 4 different exercise protocols. For example, the investigators will find out: 1. which exercise protocol is more likely to achieve a higher peak V̇O2 in females and which protocol is more likely to achieve a higher peak V̇O2 in males, 2. if enjoyment affects the duration of the test, and 3. how different exercise test protocols will provide different results of maximal oxygen used by the participant's body during the exercise test.

ANDREAS Registry (Assessment of Novel Drug-coated Balloon Revascularization: Effectiveness, Angiographic Outcomes, and Safety)

The primary objective of this protocol is to develop a comprehensive, multicenter international prospective registry to capture long-term clinical outcomes for adult patients undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) for de novo coronary artery disease.

Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events

CKJX839D12303 is a research study to determine if the study treatment, called inclisiran, in comparison to placebo taken in addition to statin medication can effectively reduce the total amount of plaque formed in the heart's vessels as measured by coronary computed tomography angiography (CCTA) from baseline to month 24. This study is being conducted in eligible participants with a diagnosis of non-obstructive coronary artery disease (NOCAD), where the coronary arteries are blocked less than 50%, and with no previous cardiovascular events.

CTSN Embolic Protection Trial

This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.