Coronary Artery Disease

This study is designed to evaluate the efficacy and safety of intravenously administered YN001 in patients diagnosed with coronary atherosclerosis, who are receiving background therapy for cardiovascular (CV) risk factors management.

The goal of this observational study is to test in the safety and performance of intraoperative myocardial spectroscopic measurement in open-heart surgery patients The main questions it aims to answer are: * The Devices can record myocardial spectrometric data for analysis, and * How these measures correlate with the occurring events, procedures, and clinical parameters during the operation. * Number of participants with device-related adverse events as assessed by CTCAE v4.0

Comparison of clinical outcomes between routine angiography follow-up and routine clinical follow-up after percutaneous coronary intervention in high-risk patients.

1. To assess the effect of high-intensity interval training on peak metabolic equivalents in patients with coronary heart disease after the coronary artery bypass grafting surgery. 2. To assess the effect of a home-based cardiac rehabilitation program on peak metabolic equivalents in patients with coronary heart disease after coronary artery bypass grafting surgery. 3. To compare functional outcomes between the different treatment approaches.

This ambidirectional observational cohort study builds upon and expands an existing coronary artery disease (CAD) cohort based on retinal fundus imaging (ChiCTR2200066429). A comprehensive baseline database will be established, including demographic characteristics, laboratory test results, coronary angiography findings, quantitative retinal vascular features, and multi-omics data.Artificial intelligence methods will be used to quantify retinal vascular characteristics and to develop and validate models for identifying and predicting CAD. In addition, targeted liquid chromatography-tandem mass spectrometry (LC-MS/MS) assays will be developed to measure previously identified CAD-related biomarkers, including metabolites and lipids, in baseline biological samples. Clinical, retinal imaging, and multi-omics data will subsequently be integrated to develop a risk stratification model for identifying individuals at high risk of CAD. Participants will be followed for cardiovascular events to evaluate the predictive performance of the model. The findings may support the development of improved strategies for CAD detection, risk assessment, and clinical management. No treatment or clinical intervention is assigned by the study protocol, and all medical decisions are made as part of routine clinical care.

The objective of this study is to assess the safety and efficacy of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI. Eligible patients will be randomized to undergo HRPCI with either the Supira System (investigational device) or the commercially available Impella systems (comparator device).

The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG, the use of two or more arterial grafts compared to a single arterial graft is associated with improved survival. Prospective event-driven unblinded randomized multicenter trial of at least 4,300 subjects enrolled in at least 25 international centers. Patients will be randomized to a single arterial graft (SAG) or multiple arterial grafts (MAG). Patients will be randomized in a 1:1 fashion between the two groups. Permuted block randomization with random blocks stratified by the center and the type of second arterial graft will be used to provide treatment distribution in equal proportion.

The goal of this clinical trial is to find out if using a non-invasive heart scan (called coronary computed tomography angiography, or CCTA) to plan coronary artery bypass grafting (CABG) works as well as the standard invasive approach (called coronary angiography, or CAG) for people with blocked heart arteries. The main questions it aims to answer are: Do people who have surgery planned with the non-invasive heart scan have similar health outcomes at 1 year as those who have surgery planned with the standard invasive approach? How does the non-invasive approach compare in terms of heart attacks, strokes, unplanned repeat procedures, and longer hospital stays? Researchers will compare two groups of participants. One group will have their surgery planned using only the CCTA . The other group will have their surgery planned using only the CAG. Both groups will undergo the CABG per local protocol. Participants will: Be randomly assigned (like flipping a coin) to one of the two planning approaches Undergo CABG as scheduled Return for follow-up visits at sugery days, 7 days, 1 month, 6 months, and 1 year after surgery Have a follow-up CCTA scan at 7 days and 1 year to check if the new bypass grafts are working well

This study aims to assess the risk factors and evaluate the long-term outcomes of patients with coronary chronic total occlusion (CTO) treated with percutaneous coronary intervention or medical treatment.

Coronary bifurcation lesions are lesions (or blockages) that occur at or near the intersection of a major coronary artery and one of the arteries' side branches. Numerous techniques and devices have been developed to treat coronary bifurcations; however, these types of lesions remain some of the most challenging, both in terms of procedural success and outcome. This study is designed as an observational, multi-center registry that will collect information on treatment strategies and outcomes of consecutive patients undergoing percutaneous coronary interventions (PCI) in coronary bifurcations among various participating centers, in order to determine the frequency of bifurcation PCI, the procedural strategies utilized, and the procedural outcomes.

Coronary angiography and percutaneous coronary intervention (PCI) is often performed in patients with ischemic heart disease. The safety of PCI has improved with new devices and strategies, but complications still occur, especially during complex procedures. The objectives of this multi-center observational registry are to examine frequency of complications occuring during cardiac catheterization and PCI, examine procedural strategies utilized for complication management, and evaluate the clinical outcomes (both immediate and during follow-up.)

Percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is increasingly being performed in patients with advanced coronary artery disease, but there is limited information on the techniques utilized and the procedural outcomes. The goal of this multicenter, investigator initiated registry is to collect information on treatment strategies and outcomes of consecutive patients undergoing CTO PCI among various participating centers. The information collected will be used to determine the frequency of CTO PCI performed at the participating sites and examine the procedural strategies utilized, and the procedural (both immediate and during follow-up) outcomes.

The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.

This multicenter prospective observational cohort study aims to investigate the association between cumulative cold-region exposure and adverse left ventricular remodeling and cardiovascular outcomes in patients with coronary artery disease undergoing successful percutaneous coronary intervention (PCI). Individual-level chronic cold exposure will be quantified primarily by cumulative months of residence, work, or other relevant exposure in cold regions during the 3 years preceding PCI. Additional exposure measures will include regional cold-wave days derived from meteorological records and winter outdoor occupational exposure. Participants will undergo baseline cardiovascular magnetic resonance (CMR), echocardiography, electrocardiography, and clinical and laboratory assessment after PCI. Echocardiography will be repeated at 6 months to assess left ventricular remodeling. Cardiovascular events will be prospectively collected during follow-up. The study will evaluate whether cumulative cold-region exposure is associated with distinct CMR phenotypes, adverse left ventricular remodeling, and major adverse cardiovascular events (MACE), and whether cold-exposure measures provide incremental prognostic information beyond conventional clinical, imaging, and electrocardiographic risk markers.

The aim of this study is to compare bleeding outcomes, pain, comfort levels, sleep quality, and associated factors among patients receiving a chitosan-based hemostatic pad versus a sandbag following femoral coronary angiography (CAG) and percutaneous coronary intervention (PCI). Femoral coronary angiography (CAG) and percutaneous coronary intervention (PCI) are widely performed procedures for the diagnosis and treatment of coronary artery disease (CAD), which remains the leading cause of mortality worldwide (Batmaz \& Cengiz, 2023; Wardiyana et al., 2024). Hemostasis following CAG and PCI is critical for preventing life-threatening complications, ensuring procedural success, and facilitating recovery. Vascular complications at the femoral arterial puncture site are among the most common adverse events associated with these procedures (Chen et al., 2021). Inadequate hemostasis may result in serious complications such as pseudoaneurysm, arteriovenous fistula, and retroperitoneal hemorrhage, all of which may pose significant risks to patient safety (Sauer et al., 2016). Effective bleeding control is particularly important in patients receiving intensive anticoagulant therapy. Following manual compression, sandbag application is commonly used to maintain hemostasis at the femoral access site. Typically, a sandbag weighing between 2.3 and 5 kilograms is placed over the puncture site, requiring patients to remain in a supine position with restricted mobility for approximately four to six hours (Batmaz \& Cengiz, 2023). Although prolonged bed rest and sandbag application contribute to hemostasis, they may also lead to adverse patient experiences, including pain, discomfort, urinary retention, restlessness, and impaired sleep quality (Batmaz \& Cengiz, 2023). Advances in medical technology have led to the development of hemostatic devices designed to rapidly control bleeding independently of the body's natural coagulation mechanisms. Among these, chitosan-based hemostatic pads, derived from crustacean shells, have attracted increasing attention. Due to their positive electrical charge, chitosan molecules attract negatively charged erythrocytes and platelets, facilitating the rapid formation of a mechanical barrier and clot within seconds (Arbel et al., 2010; Kılıç et al., 2024). Previous studies have demonstrated that chitosan-based pads may reduce manual compression time and vascular complications such as ecchymosis and hematoma (Ginanjar et al., 2018; Kılıç et al., 2024; Qian et al., 2024). Furthermore, they have been associated with improved patient comfort, earlier mobilization, and shorter hospital stays (Kılıç et al., 2024; Liu, 2025). The responsibilities of nurses following CAG and PCI extend beyond bleeding control and include comprehensive monitoring of vital signs, early detection of complications, and the promotion of patient comfort and well-being (Batmaz \& Cengiz, 2023; Rodrigues et al., 2024). While existing studies have primarily focused on the effectiveness of chitosan-based pads in reducing hematoma formation (Bektaş et al., 2017), evidence regarding their effects on broader patient-centered outcomes remains limited. Therefore, this study seeks to provide a comprehensive evaluation of chitosan-based hemostatic pads and conventional sandbag application with respect to bleeding outcomes, pain, patient comfort, and sleep quality. Accordingly, the present study aims to compare bleeding, pain, comfort levels, sleep quality, and related factors among patients undergoing femoral CAG and PCI who receive either a chitosan-based hemostatic pad or a sandbag for post-procedural hemostasis. The sample size was calculated using a power analysis based on an effect size of 0.40, a significance level of 5% (α = 0.05), and a statistical power of 80% (1-β = 0.80). According to the analysis, a total of 480 participants will be recruited, including 240 patients in the chitosan-based hemostatic pad group and 240 patients in the sandbag group.

This study aims to evaluate the feasibility and effectiveness of a sedentary behavior intervention based on the Integrated Theory of Health Behavior Change (ITHBC) in older adults with coronary heart disease and frailty. Participants will be randomly assigned to an intervention group or a control group. The intervention is designed around the three core components of ITHBC-knowledge and beliefs, self-regulation skills and abilities, and social facilitation-to help participants reduce sedentary behavior, improve physical activity, and enhance their ability to manage health-related behaviors. The study will include a 1-month intervention period followed by a 2-month follow-up period, with a total study duration of 3 months for each participant. Changes in sedentary behavior and other health-related outcomes will be assessed throughout the study period.

Adenosine is a commonly used pharmaceutical stressor at cardiac magnetic resonance examinations to assess suspected chronic coronary syndrome (CCS). However, several studies have reported that the current use of adenosine does not induce adequate hyperemic response in a substantial number of patients, leading to false diagnostics. The aim of this trial is to investigate the hyperemic effect of the standard dose of adenosine (140 microgram/kg/min) to the high dose of adenosine (210 microgram/kg/min) to improve the diagnostic methods using adenosine as a stressor and ultimately improve treatment decisions and patient prognosis in CCS.

Coronary artery bypass graft (CABG) surgery is an effective treatment for coronary artery disease; however, sleep disturbances and delirium are common during the postoperative period and may adversely affect recovery. Environmental factors, particularly light exposure, can disrupt the sleep-wake cycle and contribute to poor sleep quality. Eye masks offer a simple, safe, and non-pharmacological method of reducing light exposure and supporting sleep. This study aims to determine the effect of eye mask use on sleep quality and delirium levels in patients following CABG surgery.

This prospective, multicenter observational registry aims to establish a QFR-based quality control standard system for coronary revascularization in patients with coronary artery disease. The study will enroll over 10,000 patients with visually estimated at least one main branch coronary stenosis ≥50% from more than 50 centers across China (covering provincial, municipal, and county-level hospitals). Coronary angiographic images and intracoronary imaging (if available) will be collected and retrospectively analyzed by an independent core laboratory. The primary endpoint is QFR acquisition accessibility, defined as the mean of QFR usage proportion across centers.

This randomized controlled study will evaluate whether icosapent ethyl (IPE) can improve and stabilize high-risk coronary plaques in patients receiving stable low-density lipoprotein cholesterol (LDL-C)-lowering therapy. Potential participants will have coronary plaques identified by coronary computed tomography angiography (CCTA), with 30% to 70% narrowing in at least one major coronary artery and at least one high-risk plaque feature. After baseline imaging with fluorine-18 sodium fluoride positron emission tomography/computed tomography (18F-NaF PET/CT), eligible participants will be randomly assigned in a 1:1 ratio to receive either IPE 2 g twice daily plus standard LDL-C-lowering therapy or standard LDL-C-lowering therapy alone for 12 months. At the end of treatment, participants will undergo repeat CCTA and 18F-NaF PET/CT. Blood biomarkers and major adverse cardiovascular events will also be assessed during follow-up.

Objectives: To assess the safety of tailored antiplatelet therapy (short DAPT followed by P2Y12 inhibitor alone strategy) in patients who received optimized DES implantation guided by intravascular imaging (IVUS or OCT) Hypothesis: Tailored antiplatelet strategy (short DAPT followed by P2Y12 inhibitor alone) is superior to conventional antiplatelet strategy in terms of clinically relevant bleeding and noninferior for ischemic composite adverse events in patients who received intravascular imaging-guided optimized DES implantation. (Optimized stent evaluated by on-site IVUS/OCT could act as an essential criterion for decision making for tailored antithrombotic strategy)

This registry aimed to investigate drug-coated balloon procedural factors (particularly delivery time and inflation duration) to evaluate the impact on angiographic and clinical outcomes in patients undergoing percutaneous coronary intervention for de novo coronary lesions.

This study aimed to characterize the progression and risk fators of coronary artery aneurysms, and copmpare the outcomes across different management strategies

The TURK CTO Registry is a prospective, multicenter, observational registry designed to evaluate the contemporary management and outcomes of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) in Türkiye. The registry will include consecutive adult patients undergoing CTO PCI at participating centers. Detailed data on patient characteristics, cardiovascular risk factors, lesion and procedural characteristics, CTO crossing strategies, guidewires and devices, procedural techniques, radiation exposure, contrast use, procedural success, and in-hospital complications will be collected using a standardized electronic data collection system. The primary objective of the registry is to characterize contemporary CTO PCI practice in Türkiye and to evaluate procedural success and safety. Secondary objectives include identifying clinical, angiographic, and procedural factors associated with technical and procedural success, complications, resource utilization, and patient outcomes. The registry is expected to provide real-world, multicenter data on CTO PCI practice and to help identify factors associated with successful and safe CTO revascularization in Türkiye. No treatment or procedural strategy will be assigned by the study protocol; all clinical and procedural decisions will be made by the treating physicians according to routine clinical practice.

The ACCURATE-PRO study is an investigator-initiated, prospective, multicenter, observational, real-world cohort study. The core objective in managing chronic coronary syndrome (CCS) is to identify clinically significant myocardial ischemia to guide treatment decisions and improve long-term prognosis. While coronary computed tomography angiography (CCTA) is a crucial non-invasive anatomical imaging tool, it has limitations in determining the functional significance of coronary stenosis. Computed tomography-derived fractional flow reserve (CT-FFR) provides this functional assessment non-invasively based on CCTA images. However, there is a lack of systematic, prospective, multicenter evidence regarding its clinical value in risk stratification, treatment decision support, and prognostic evaluation for a continuous, real-world spectrum of CCS patients in China. This study aims to evaluate the relationship between abnormal CT-FFR results and the risk of 1-year major adverse clinical events in CCS patients undergoing CCTA and CT-FFR. The study hypothesizes that abnormal CT-FFR is associated with a higher risk of 12-month major adverse clinical events, and that CT-FFR results are significantly correlated with subsequent treatment strategies, providing important value in risk stratification and mid-to-long-term prognosis. The trial plans to consecutively enroll approximately 3,000 patients across multiple clinical centers in China. Eligible participants must be 18 years or older, have a clinical diagnosis of CCS, and have successfully obtained CT-FFR results following a CCTA examination. Patients will be excluded if they have acute coronary syndrome (such as STEMI, NSTEMI, or acute unstable angina), unanalyzable CT-FFR results/image quality, or non-cardiac conditions limiting their life expectancy to less than one year. Since this is an observational study, it will not alter routine clinical care pathways or assign interventions. The primary exposure factor analyzed will be the lowest CT-FFR result per patient, comparing an abnormal CT-FFR group (≤ 0.80) to a normal CT-FFR group (\> 0.80). Participants will be followed up via telephone, outpatient visits, or hospitalization at 6, 12, 24, and 60 months after enrollment. The primary endpoint is a composite of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization within 1 year after enrollment. Key secondary endpoints include the occurrence of the primary endpoint at 24 and 60 months, target vessel failure (a composite of cardiac death, target vessel MI, or target vessel revascularization), stroke, health economics analysis, and the association between CT plaque characteristics and clinical outcomes.