Clinical Research Directory

The Effectiveness of a Theory-driven Behavioral Change Intervention on Sedentary Behavior in Individuals With Coronary Heart Disease: A Randomised Controlled Trial

The objective of this randomised controlled trial is to examine the effectiveness of a theory-driven behavioural change intervention on total sedentary time (primary outcomes), moderate-to-vigorous physical activity time, intention of behavioural change, future time perception, behavioural prepotency, self-regulation capacity, and exercise capacity in individuals with coronary heart disease. Hypotheses: Compared to the participants in the control group, participants in the intervention group will demonstrate: 1. Significantly less total sedentary time 2. Significantly improved MVPA time, 3. Significantly better intention of behavioural change, 4. Significantly higher level of behavioural prepotency, 5. Significantly enhanced self-regulation capacity, and 6. Significantly greater future time perception 7. Significantly better exercise capacity at the immediate post-intervention (T1), the 1-month post-intervention (T2), and the 6-month post-intervention (T3). Participants will: Participants in the intervention group will participate in a theory-driven behavioural change intervention over three months, comprising four individual face-to-face sessions (45 minutes each) and four individual telephone sessions (20 minutes each), along with the usual care. Participants in the attention control group will continue to have the usual care, which includes regular follow-up at the cardiac clinic. Education sessions, consisting of information about healthy lifestyles, except physical activity and sedentary behaviour, with the same schedule as the intervention group, will be provided to account for potential attention effects from contacts.

Effectiveness of a Tele-cardiac Rehabilitation (Tele-CR) Program

This study represents the second phase of a three-year research project aimed at evaluating both the short- and long-term effects of a six-month tele-cardiac rehabilitation (tele-CR) program in patients with coronary heart disease (CHD). The primary outcomes include quality of life, self-efficacy, self-management, medication adherence, and mental health (anxiety and depression). In addition, comprehensive metabolic parameters will be assessed, including body mass index (BMI), systolic and diastolic blood pressure (SBP and DBP), fasting blood glucose (FBG), glycosylated hemoglobin (HbA1C), and lipid profile markers such as triglycerides (TG), total cholesterol (TC), high-density lipoprotein (HDL), and low-density lipoprotein (LDL).

Proteomic and Inflammatory Omics Changes With Colchicine Therapy in Coronary Heart Disease

The goal of this exploratory clinical trial is to investigate the proteomic changes induced by low-dose colchicine anti-inflammatory therapy in coronary heart disease (CHD) patients, with the aim of identifying novel biomarkers and therapeutic targets. The main questions it aims to answer are: * Whether short-term colchicine treatment induces significant changes in the plasma proteomic profile of post-PCI CHD patients with residual inflammation. * Which specific proteins or pathways are dynamically modulated by colchicine, indicating potential mechanisms of action and drug targets. * How the proteomic expression profiles differ between patients treated with colchicine and matched controls after one month. Participants, recruited based on a prior RCT framework, will be post-PCI CHD patients with elevated inflammation (hs-CRP ≥ 2 mg/L). A total of 176 participants will be enrolled: 88 in the trial group (colchicine 0.5 mg/day) and 88 in the matched control group (no intervention). All participants will complete a one-month follow-up. Peripheral blood samples will be collected at baseline and at the one-month visit for high-throughput proteomic analysis using Olink technology.

Scalable Clinical Oversight of Large Language Models Via Uncertainty Triangulation

This prospective, multi-reader, randomized crossover trial evaluates SCOUT (Scalable Clinical Oversight via Uncertainty Triangulation), a model-agnostic meta-verification framework that selectively defers unreliable large language model (LLM) predictions to clinicians by triangulating three orthogonal uncertainty signals: model heterogeneity, stochastic inconsistency, and reasoning critique. The trial assesses whether SCOUT-assisted review can reduce physician review time compared with standard manual review of AI-generated diagnoses while maintaining non-inferior diagnostic accuracy in coronary heart disease (CHD) subtyping.

A Prospective Multicenter Clinical Study： IntracOronary neaR-Infrared Spectroscopy and OptIcal Coherence Tomography for Evaluating Coronary vulNerable Plaque in Patients With diabeTes

To evaluate the correlation between maxLCBI4mm/FCTmin(a new index of lipid plaque based on NIRS-OCT technology) and fiber cap thickness , and the prognosis of patients, providing a new quantitative index for early, accurate and comprehensive identification of vulnerable plaques, and exploring preventive measures for adverse events such as cardiac death and recurrent myocardial infarction caused by vulnerable plaques, so as to improve the long-term prognosis of patients.

REsiduAL rISk Under Intensive Lipid-lowering Therapy In Coronary Heart Disease

Intensive lipid-lowering therapy is a cornerstone treatment for coronary heart disease (CHD). However, coronary plaque progression persists in a subset of patients even under intensive lipid-lowering therapy, which may be associated with residual lipid and inflammatory risks. Current research in this area remains largely confined to post hoc analyses of randomized controlled trials , with a notable scarcity of prospective follow-up cohorts. The investigators propose that establishing a prospective cohort will provide more authentic insights into the associations between residual risk factors and plaque progression. In this project, the investigators aim to establish a well-characterized CHD cohort with comprehensive data collection, good compliance, and an appropriate sample size. By focusing on non-target lesions within the target vessel and utilizing intravascular ultrasound (IVUS), the investigators will investigate the impact of residual lipid and inflammatory risks on plaque progression during intensive lipid-lowering therapy.

AI-Driven Dynamic Prediction of Non-Target Lesion Progression After PCI: A Chinese Multicenter Cohort Study

Coronary artery disease remains a leading cause of global mortality. Although percutaneous coronary intervention (PCI) improves patient outcomes, the long-term risk of major adverse cardiovascular events (MACE) driven by the progression of non-target lesions (NTLs) remains substantial and continues to increase, while current risk stratification tools remain inadequate for predicting NTL progression. This multicenter cohort study aims to develop an artificial intelligence (AI)-driven system for the dynamic prediction and precision stratification of NTL progression after PCI. Utilizing comprehensive multimodal data from 52,577 Chinese patients-including clinical profiles, multi-omics blood biomarkers, and coronary imaging-the research pursues three primary objectives: (1) to identify and validate 2-3 specific biomarkers for NTL progression risk using multi-omics approaches; (2) to construct an integrated risk assessment and early-warning system by applying machine learning to multimodal data for predicting NTL progression and MACE; and (3) to establish metabolic and imaging-based subtypes to create a precision management system that optimizes secondary prevention strategies by identifying specific high-risk populations. This study is expected to provide a novel tool for accurate identification of high-risk patients and personalized post-PCI management, ultimately aiming to improve long-term prognosis.

CORE-COMPARE Pilot Study

The utility of Ultra High-Resolution Computed Tomography (UHR-CT) compared to conventional CT in all-comers (i.e., a generally lower-risk population) remains uncertain but is an important area of study in order to justify wider spread implementation and use of this technology, particularly in light of reports of significantly higher radiation exposure with UHR-CT, as well as longer scan times. The availability of technology to reconstruct conventional resolution (CR) simulation images from the raw CT acquisition data acquired on the UHR-CT scanner offers a unique platform to study this question without subjecting individuals to two different scans. The primary objective of this study is to generate preliminary data in support of the hypothesis that noninvasive UHR-CT is superior to conventional resolution CT for identifying patients with obstructive CHD.

The Role of 4 Different Consent Approaches on a Pilot Study to Increase Cardiac Rehabilitation Attendance

Cardiac Rehabilitation is a lifestyle and exercise program for patients with heart disease. Cardiac Rehabilitation is strongly recommended in guidelines, but only 30% of eligible patients attend. New strategies are needed to help more patients attend cardiac rehabilitation. In this study, the investigators will see if using an $50 incentive, case management, text messages, and physical activity coaching combined into a single intervention will help more patients attend cardiac rehabilitation. In preparation for a larger trial, patients will also be randomly assigned to four different ways of seeking their permission to be in a research study. The investigators will see if these approaches affect how many people participate in the research project. The two main goals of this study is to understand: 1. If the consent approach type impacts participation rates in the research study 2. If the multi-component intervention (case management, financial incentives, text messages, and physical activity coaching) improves cardiac rehabilitation participation within 3 months.

Closed-Loop Neurofeedback Targeting the Left Dorsolateral Prefrontal Cortex for Cardiac Autonomic Modulation in Coronary Artery Disease With Anxiety

The goal of this clinical trial is to test whether closed-loop fNIRS-BCI neurofeedback(NF) targeting the left dorsolateral prefrontal cortex(DLPFC) can reduce cardiac autonomic arousal, indexed by baseline-corrected heart rate(HR) under cold-induced pain stress, in adults with stable coronary heart disease(CHD) and comorbid anxiety. The main questions it aims to answer are: Does real left DLPFC neurofeedback, compared with sham neurofeedback, lead to a greater reduction in baseline-corrected HR during the cold-induced pain stimulation window? Does real neurofeedback produce stronger volitional upregulation of left DLPFC activation and higher inter-hemispheric synchronisation between left and right DLPFC than sham neurofeedback? Are changes in baseline-corrected HR statistically associated with, and partly mediated by, changes in left DLPFC activation or DLPFC inter-hemispheric synchronisation? What adverse events(AEs) occur during adaptive training and the formal experimental session, and do AE rates differ between the two groups? Researchers will compare a real neurofeedback group with a sham neurofeedback group to determine whether targeting the left DLPFC via closed-loop fNIRS-BCI yields superior modulation of cardiac autonomic responses and prefrontal activation patterns in CHD patients with anxiety. Participants will: undergo cardiac and psychiatric screening to confirm stable CHD, DSM-5 anxiety disorder, and other eligibility criteria; attend three adaptive training sessions(days 1-3) with fNIRS-BCI neurofeedback targeting the left DLPFC, combined with slow-wave auditory stimulation and mild cold-water exposure, while ECG is recorded; on day 4, complete one formal experimental session consisting of 15 blocks of cold-induced pain stimulation and slow-wave auditory stimulation, with simultaneous fNIRS and ECG recording, receiving either real or sham left DLPFC neurofeedback according to randomisation, and continuous monitoring for adverse events.

Closed-Loop Neurofeedback Targeting the Right Dorsolateral Prefrontal Cortex for Cardiac Autonomic Modulation in Coronary Artery Disease With Anxiety

The goal of this clinical trial is to test whether real-time fNIRS-BCI neurofeedback targeting the right dorsolateral prefrontal cortex (right DLPFC), using active volitional control during a slow-wave auditory acoustic paradigm, can suppress cardiac sympathetic activity and improve autonomic regulation in right-handed patients with stable coronary heart disease (CHD) and comorbid DSM-5 anxiety. The main questions it aims to answer are: Does real neurofeedback, compared with sham, reduce baseline-corrected heart rate during the auditory stimulation window? Does real neurofeedback, compared with sham, increase HRV spectral power around 0.0167 Hz (1/60 Hz) and produce stronger suppression of right DLPFC activation? Does suppression of right DLPFC activation mediate the effect of group assignment on heart rate? If there is a comparison group: Researchers will compare the real neurofeedback group with the sham (non-contingent) feedback group, which uses identical audio and interface, to determine whether coupling feedback to right DLPFC activity yields autonomic benefits. Participants will: Complete eligibility screening in cardiology and psychiatry and provide informed consent; baseline demographics, medical history, vital signs, and medications are recorded (HAMA/HAMD used for eligibility only). Undergo a 3-day adaptation phase to practice active volitional self-regulation while viewing a real-time energy bar mapped to right DLPFC statistics; adaptation data are not analyzed for outcomes. Attend two formal sessions (Days 4-5), each with 15 blocks of 60 s (20 s rest + 40 s stimulus). The auditory stimulus is a 1 Hz amplitude-modulated pure tone at approximately 60 dB; 10-second white-noise bursts are randomly embedded within the 40-second window. During the stimulation period, participants receive real or sham feedback on right DLPFC activation and act to push the energy bar below an unlabeled threshold line using active volitional strategies. Undergo synchronous fNIRS (HbO) and 3-lead ECG (1,000 Hz) recording throughout; online processing and rendering performance metrics are logged; adverse events are monitored and managed per protocol.

Coronary Heart Disease Complicated With Ischemic Mitral Regurgitation in China

This project will rely on the established multi-center cooperation platform for total valve disease and based on the Carpentier classification, which is newly proposed and widely recognized by the academic community, and will specifically target the population with coronary heart disease combined with Ischemic Mitral Regurgitation（IMR） to conduct a nationwide, multi-center, single valve disease, prospective cohort. Research. From November 2025 to December 2025, 6,000 patients with coronary heart disease combined with moderate or above IMR were consecutively selected from outpatients or inpatients in 21 regional medical centers across the country, and clinical characteristics, imaging data, and serology were collected. Information, drug/surgical intervention status and clinical outcome indicators were included in the clinical follow-up at baseline, 3 months, 6 months, 12 months and 24 months respectively. The main research objectives are to describe the disease characteristics, treatment status and clinical outcomes of coronary heart disease patients with IMR; to evaluate the current application status of GDMT strategies in IMR diagnosis and treatment practice and its impact on mid- and long-term prognosis. The secondary research objectives are to identify factors affecting prognosis, construct a risk stratification model for mid- and long-term prognosis, and discover new molecular markers. This project will for the first time construct the world's largest clearly defined cohort of coronary heart disease combined with IMR. Its research results can provide high-quality data and decision-making basis for precise diagnosis and treatment of IMR populations. Therefore, this project has important scientific research value and clinical guidance significance.

Verona Coronary Physiology Interventional Registry

The Verona Coronary Physiology Interventional Registry (VR-CP) is an observational study that collects information on patients with suspected coronary artery disease who underwent coronary angiography with a functional assessment of coronary stenoses. These functional tests include fractional flow reserve (FFR) or angiography-derived FFR, which help physicians understand whether a narrowing in the coronary arteries is likely to reduce blood flow to the heart. The main goal of the study is to investigate whether the functional severity of coronary lesions is associated with future cardiovascular events, such as heart attack, the need for repeat procedures, or cardiovascular death. Additional objectives are to compare invasive FFR with angiography-derived FFR, to evaluate how these values relate to angina symptoms, and to analyze differences between patients treated conservatively with medications and those treated with coronary interventions. The study is retrospective and single-center, including approximately 1,000 patients who underwent coronary physiology testing between 2010 and 2024 at the University Hospital of Verona. Follow-up information is obtained through review of medical records, outpatient visits, or telephone contacts, and patients will be followed for up to 10 years. By combining detailed coronary physiology data with long-term clinical outcomes, this registry aims to improve understanding of which patients are at higher risk and to guide future strategies for the diagnosis and treatment of coronary artery disease.

Clinical Outcomes of Patients With Coronary Artery Disease

Coronary heart disease (CHD) stands as a foremost contributor to global mortality, characterized by complex pathogenesis that renders conventional "one-size-fits-all" preventive strategies inefficient. Therefore, the investigators designed a prospective, multi-center cohort study among patients hospitalized due to either confirmed or suspected CHD, which aimed to establish a holographic data set for the diagnosis and treatment of CHD and explore the impact of critical therapeutic strategies in the real world on the clinical outcomes of CHD patients, providing evidence to optimize the management pathway.

Community Exercise Treating Effect on Cardiopulmonary Disease Patients

The goal of this clinical trial is to learn if community-based exercise training can benefit patients aged 18 to 85 with diminished cardiovascular and pulmonary function. The main aim of this study is: • Establish a community or home-based fitness training program for patients with cardiopulmonary insufficiency to improve adherence, safety, and efficacy while alleviating the burden on both patients and society. Researchers will compare community-based exercise training to non-exercise training to see if community-based exercise training works to improve cardiovascular and pulmonary function. Participants will: * Engage in community or home exercise training for 40-60 minutes, five times weekly, during a duration of eight weeks. Exercise modalities are primarily determined by the patients' individual preferences and habits, such as brisk walking, running, swimming, cycling, and hiking. * Adjust the exercise intensity according to their cardiopulmonary exercise test and the person's perceived exertion level. * Utilize fitness bracelets or watches to document statistics during workouts and submit them to the experimenter weekly, covering the five days of exercise within that week. * refrain from making any dietary modifications throughout the trial.

Village-Based Management of Chronic Cardiovascular Disease in Qu Jiang Elderly Population Registry: The BOUQUET Cohort Study

This is a prospective observational cohort study conducted in Qujiang District, Zhejiang Province, China, aiming to evaluate the effectiveness of a comprehensive management program for elderly patients with chronic cardiovascular diseases (CVDs). The program integrates pharmacological treatment, lifestyle modification, health education, and long-term follow-up, with enhanced monitoring using 7-day ECG recording. The study focuses on major chronic CVDs including hypertension, coronary artery disease, atrial fibrillation, and heart failure. Approximately 30,000 participants aged ≥60 years will be enrolled and followed for up to 10 years.

Effect of eHealth Cardiac Rehabilitation Incorporating Mindfulness for Patients With Coronary Heart Disease

People with coronary heart disease (CHD) often feel more stressed, which can increase the risk of having another heart problem. Cardiac rehabilitation (CR) is a common treatment for those with CHD, focusing on changing lifestyles and managing the disease. However, it often does not address stress management adequately. There is also a lack of psychological therapy and involvement of mental health professionals in online CR programs. Because traditional CR programs have low participation rates, online platforms are becoming more popular for providing rehabilitation support. This is important because more than half of people with CHD report high stress levels, which can cause or worsen heart problems. To address this issue, the proposed study will test an online CR program that includes mindfulness to help manage stress for CHD patients.

Assessment of the Diagnostic Performance of the Detection System and Establishment of an Intelligent and Rapid Triage Model

The rapid triage of patients with acute chest pain remains an important issue in clinical practice. This study will establish a cohort of patients suspected of acute coronary syndrome (ACS) to construct a multi-marker dynamic combined intelligent triage model. This model will triage the risk of NSTEMI in patients with chest pain at their first visit. It will also stratify the risk of patients with chest pain using major adverse cardiovascular events (MACE) within 30 days as the endpoint.

Reliability of Multiple-Repetition-Maximum Tests in Patients with Cardiovascular Disease or Risk Factors

Exercise training is a cornerstone in the prevention and rehabilitation of cardiovascular disease. While research has primarily focused on endurance training, resistance training becomes more and more important. The gold standard to prescribe resistance training intensity or monitor longitudinal changes is the 1-Repetition-Maximum (1-RM) test. However, particularly for unexperienced individuals, this test may not be recommendable due to the high load and an increased risk of injuries. Alternatively, there are several published formulas to estimate the 1-RM based on a multiple-repetition-maximum (or repetition-to-failure) test. However, these formulas have been primarily tested in healthy individuals. Moreover, the reliability of the 1-RM estimation based on two tests with different submaximal weight is unknown. Therefore, the present study evaluates the agreement of the 1-RM estimation (based on different formulas) between two Multiple-RM tests with different weight in 50 patients with cardiovascular disease (heart failure, coronary heart disease, atrial fibrillation) or cardiovascular risk factors (type 2 diabetes, arterial hypertension).

Protective Effect of EECP Against Negative Inflammatory Response and Organ Dysfunction After Cardiovascular Surgery

Enhanced external counterpulsation (EECP) is a noninvasive, non-pharmacologic intervention proven to increase nitric oxide bioavailability in patients with coronary artery disease. Although EECP showed short-term effects in improving coronary flow in patients with coronary slow flow, whether such improvement is durable remains uncertain, and the relationships between such improvement and changes in multiple organ functions as well as inflammatory markers have not been elucidated. The purpose of this study will be to evaluate the potential clinical benefits of EECP on organ function and proinflammatory cytokine concentrations during post-acute sequela of cardiovascular surgery.

Using Retinal Photograph Based AI to Predict Incident Coronary Heart Disease

To determine whether an integrated retinal AI decision support can improve predictive accuracy of coronary heart disease (CHD), the investigators are conducting a randomized controlled study of AI guided prediction of CHD compared to clinical prediction by physicians (e.g., usingPCEs), both using clinical intuition as baseline.

a Foundational Model for Cardiovascular Disease Diagnosis and Prediction

The goal of this observational study is to develop and evaluate the efficacy of a foundational model that integrates multimodal medical data to improve the diagnosis and prediction of cardiovascular diseases in patients aged 18 and older, including those with various heart conditions such as coronary artery disease, heart failure, and arrhythmias. The main questions it aims to answer are: Can a multimodal data-based diagnostic model match or exceed the accuracy of traditional gold-standard methods like coronary angiography, MRI, and echocardiography? Does integrating different types of data (ECG, imaging, biochemical tests) improve diagnostic accuracy and prediction of cardiovascular disease outcomes? Researchers will compare the foundational model with traditional diagnostic methods to see if the model offers better sensitivity, specificity, and prediction accuracy across different heart disease types. Participants will: Provide data from past medical records, including ECG, echocardiography, cardiac MRI, and biochemical tests. Undergo further data collection if necessary, in line with standard clinical procedures for cardiovascular disease management.