Evaluating plaque progression in coronary artery disease using advanced imaging techniques
Evaluation of Atherosclerotic Plaque Progression by Coronary Computed Tomography Angiography and Intracoronary Imaging Techniques in Patients With Coronary Artery Disease
This study is testing how advanced imaging can help us understand the growth of plaque in the arteries of people with coronary artery disease over five years and how different factors and treatments affect their heart health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 2 sites (Shanghai and 1 other locations) |
| Trial ID | NCT06794684 on ClinicalTrials.gov |
What this trial studies
This observational cohort study involves patients with coronary artery disease (CAD) who will be followed for up to 5 years. Participants will undergo repeat coronary CT angiography (CTA) after 2 years, and those referred for invasive coronary angiography will receive additional intracoronary imaging techniques. The study aims to analyze the morphological and functional characteristics of atherosclerotic plaques, their progression, and the impact of various cardiometabolic factors and treatments on major adverse cardiovascular events (MACEs). Blood samples will also be collected for further analysis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with clinically significant angina or suspected CAD who have visible plaque on coronary CTA.
Not a fit: Patients with severe renal impairment, recent coronary interventions, or significant comorbidities such as malignancies or advanced heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of coronary artery disease, potentially reducing the risk of major cardiovascular events.
How similar studies have performed: Other studies utilizing advanced imaging techniques for plaque analysis have shown promise, indicating that this approach may yield valuable insights into CAD management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Clinically significant angina pectoris, or suspected CAD * Receive coronary CTA scan, with a visible plaque (defined as ≥25% diameter stenosis) in major coronary arteries. Exclusion Criteria: * Unsuitable for coronary CTA (such as severe renal impairment, uncontrolled thyroid condition, allergic to iodine, etc.) * Receive percutaneous coronary intervention (PCI) within 6 months * Prior history of myocardial infarction or heart failure * Prior history of percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) * Abnormal liver function (serum alanine aminotransferase \[ALT\] level exceeding 3 times the upper limit of normal) or abnormal kidney function (eGFR ≤30 ml/min) * Familial hypercholesterolemia * Estimated survival ≤ 1 year * Malignant tumor * Pregnant or lactation, or have the intention to give birth within one year * Poor coordinance, unable to follow-up
Where this trial is running
Shanghai and 1 other locations
- CAAC East China Aviation Personnel Medical Appraisal Center, Civil Aviation Shanghai Hospital — Shanghai, China (Recruiting)
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Ruiyan Zhang, M.D., Ph.D. — Ruijin Hospital
- Study coordinator: Xiaoqun Wang
- Email: wangxq@shsmu.edu.cn
- Phone: +86 21 64370045 671605
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.