Clinical Research Directory

Effect of Periodontal Therapy on Asprosin in Stable Angina

This study aims to evaluate the effect of non-surgical periodontal therapy on serum asprosin levels in patients with stable angina and periodontitis. Asprosin is a novel metabolic biomarker reported to have potential protective roles in cardiovascular diseases and inflammatory processes. The study also investigates the relationship between periodontal parameters and serum asprosin levels before and after periodontal therapy.

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.

Clinical Evidence With Biomarker Confirmation for PPMI in PCI Clinical Trials Study

The goal of this prospective, multicenter, non-randomized observational study is to better identify and understand periprocedural myocardial injury among adults undergoing percutaneous coronary intervention (PCI) for stable coronary artery disease or stabilized non-ST-elevation acute coronary syndrome. The main questions it aims to answer are: * Can a clinical criteria checklist identify patients with an increased likelihood of cardiac biomarker elevation following PCI? * Are positive clinical criteria and different post-PCI levels of troponin I, troponin T, and CK-MB associated with all-cause mortality or hospitalization for heart failure at one year? Researchers will compare participants with a positive clinical criteria checklist with those with a negative checklist to assess differences in post-PCI biomarker elevations and one-year clinical outcomes. Outcomes will also be compared between participants discharged on the same day and those hospitalized overnight. Participants will: * Undergo PCI using commercially approved devices according to local standards of care. * Have blood samples collected before and after PCI to measure cardiac biomarkers. * Have relevant clinical and PCI procedural information collected, including completion of a clinical criteria checklist by the study team before discharge. * Be followed for one year to determine whether they have died from any cause or been hospitalized for heart failure.

BRIDGE Trial: Embedding Consumer-grade mHealth Technologies Into Cardiac Rehabilitation

The purpose of the BRIDGE study is to learn whether supplementing traditional center-based cardiac rehabilitation (CBCR) with a mobile health technology intervention can help patients monitor their health, stay engaged in healthy lifestyle behaviors, better manage cardiovascular risk factors, and improve overall health outcomes. Cardiac rehabilitation is an evidence-based outpatient program designed to help people recover from heart-related conditions through supervised exercise, education, counseling, and support for healthy lifestyle changes. Although cardiac rehabilitation is highly recommended and beneficial, many patients do not receive the full benefits of the program. Some patients attend fewer sessions than recommended, and many find it difficult to maintain healthy habits outside of the clinic, such as regular physical activity, heart-healthy eating, taking medications as prescribed, monitoring blood pressure, and managing weight. This study will test whether combining CBCR with mobile health tools may improve participation and support healthy behaviors at home. Mobile health tools include mobile phone applications, connected devices such as a weight scale, blood pressure monitor, and activity tracker, as well as personalized text messages designed to encourage and support healthy self-care. This study will help determine whether these mobile health tools can make cardiac rehabilitation more effective and help patients maintain healthy behaviors beyond the clinic setting.

Heterogeneity of Neointimal Healing Following Biodegradable-polymer Drug-Eluting Coronary Stent Implantation

The objective of this study is a comparative evaluation of Orsiro stent and of Resolute Integrity stent in terms of the extent of neointima formation at 4 months after implantation using optical coherence tomography (OCT).

1 or 6 Months of Dual Antiplatelet Therapy After Drug-coated Balloon Angioplasty for De-novo Small Coronary Artery Disease

1. Objective Objective: \> The purpose of this study is to evaluate whether a short-term (1-month) dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) is non-inferior to the standard 6-month DAPT in patients undergoing Drug-Coated Balloon (DCB) angioplasty for de novo small coronary artery disease. Methods: \> This is an open-label, randomized, non-inferiority trial. Patients will be assigned to either 1 month or 6 months of DAPT after successful DCB treatment. The study will compare the incidence of Net Adverse Clinical Events (NACE)-a composite of cardiovascular death, myocardial infarction, target vessel revascularization, and major bleeding-between the two groups from 1 to 12 months post-procedure. 2. Background Following percutaneous coronary intervention (PCI), dual antiplatelet therapy (DAPT) is essential to prevent stent thrombosis and ischemic events. While short-duration DAPT (e.g., 4 weeks) has shown benefits in patients at high bleeding risk, evidence regarding the optimal DAPT duration specifically after Drug-Coated Balloon (DCB) angioplasty for small vessel disease remains insufficient. This study aims to fill this clinical gap by comparing 1-month versus 6-month DAPT strategies. Primary Objective To demonstrate the non-inferiority of 1-month DAPT (followed by SAPT up to 12 months) compared to 6-month DAPT in terms of Net Adverse Clinical Events (NACE) occurring between 1 and 12 months post-randomization. Secondary Objectives To evaluate ischemic safety (CV death, MI, TLR). To assess bleeding safety (BARC type 2, 3, or 5). To analyze individual components of the primary composite endpoint, including all-cause death and stent thrombosis.

AI-Enhanced Single-Lead ECG Screening for Coronary Stenosis

It is a prospective, controlled, single-center, non-randomized, observational study. Two patient groups are planned for inclusion: the first - 200 patients with significant coronary artery stenosis confirmed by coronary angiography (CAG) or multislice computed tomography (MSCT) results; the second - a control group consisting of 200 patients without significant stenosis according to CAG or MSCT data. All study subjects will have a date of coronary artery imaging via CAG or MSCT with assessment of myocardial perfusion. Stress echocardiography tests or fractional flow reserve (FFR) assessment will be conducted as indicated. All patients included in the study will undergo ECG recording within 1 month before or after CAG or MSCT in standard lead I for 1 minute, followed by spectral analysis of the obtained data, which will be stored at the remote monitoring center of Sechenov University without being linked to the personal data of patients. A spectral analysis of the electrocardiogram will be performed using a continuous wavelet transform. The result of this study will be the identification of ECG parameters that correlate with significant coronary artery stenosis.

Comprehensive Invasive Physiological Evaluation of Obstructive Coronary Artery Disease

The goal of this clinical trial is to test whether adding coronary function testing and starting targeted medical treatment for identified vasomotor disorders will also improve angina symptoms and quality of life in patients with obstructive coronary artery disease who undergo percutaneous coronary intervention. The main question it aims to answer is: Does performing coronary function testing in patients with obstructive coronary artery disease who undergo percutaneous coronary intervention lead to better relieve of angina symptoms and improvement in quality of life? Researchers will compare this group undergoing coronary function testing with a control group who will solely undergo percutaneous coronary intervention. Participants will: * Undergo percutaneous coronary intervention and coronary function testing in the intervention arm * Undergo percutaneous coronary intervention in the control arm

Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)

The purpose of this research is to find out if doing cardiac rehab at home, or a mix of cardiac rehab at home and in the clinic, is as effective as coming in to the clinic for cardiac rehab.

TTE Improves Clinical Management of Stable Chest Pain

The investigator aims to prospectively enroll patients who were referred for transthorcic echocardiography (TTE) for the assessment of stable chest pain (SCP) suspected of obstructive coronary artery disease (CAD). All patients underwent TTE according to established guidelines and local institutional protocols. This study will determine if TTE-based imaging evaluation can provide more informaton to improve clinical management for SCP, including fewer MACE and better decision-making of downstream investigations and therapeutic interventions.

The Effects of Tirzepatide in People With Overweight/Obesity and Coronary Artery Disease

The objective of this study is to investigate, as a proof-of-principle, long-term (52 weeks) effects of tirzepatide once-weekly vs. placebo on changes in coronary plaque composition and progression (assessed by NIRS), plaque burden (assessed by IVUS) and microvascular function (assessed by invasively measured CFR) in overweight and obese individuals with stable coronary artery disease (CAD). In addition, the objective of a baseline cross-sectional sub-study is to explore potential metabolic and cardiovascular (CV) predictors for high arteriosclerotic plaque burden in overweight and obese individuals and to establish a cohort for future research projects.

A Multi-center, Real-World Clinical Trial of caIMR on Two Specific Kinds of Patients.

The coronary angiography-derived index of microcirculatory resistance (caIMR) can be used to provide a binary assessment whether patients（with stable angina, unstable angina, suspected myocardial ischemia, or coronary artery stenosis of less than 50%, and without cardiomyopathy or obstructive epicardial coronary artery disease） have microcirculatory dysfunction, using a cutoff value of 25. This study aims to evaluate the binary classification performance of caIMR in two specific groups of patients: (1) those with caIMR values between 20 and 30, and (2) those with diffuse disease. We will do this by looking at differences in their Seattle Angina Questionnaire (SAQ) scores and their health outcomes over a three-year period.

Efficacy and Safety of Aspirin in Patients With Chronic Coronary Syndromes Without Revascularization

The purpose of this study is to evaluate the efficacy and safety aspirin in patients with chronic coronary syndromes without revascularization.