Evaluating coronary artery disease risk using advanced imaging and AI techniques
Coronary Computed Tomography Angiography and Functional Analysis in Risk Stratification of Coronary Artery Disease: A Prospective, Multi-center Cohort Study
This study is testing if advanced imaging and AI can better determine the heart health risks for people with coronary artery disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 9 sites (Cangzhou, Hebei and 8 other locations) |
| Trial ID | NCT05856110 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective cohort study aims to continuously enroll patients with coronary artery disease to assess their cardiovascular risk using non-invasive coronary CTA imaging. Participants will undergo detailed anatomical and functional analysis, along with proteomics research and clinical follow-up for cardiovascular events. The study seeks to establish a new risk stratification system that improves upon traditional methods by utilizing advanced imaging technology and artificial intelligence. By addressing the limitations of current diagnostic approaches, this research aims to enhance the accuracy of risk assessment and treatment decisions for patients with coronary artery disease.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-80 who experience clinically significant angina pectoris and are suspected of having coronary artery disease.
Not a fit: Patients who may not benefit from this study include those with severe renal impairment, prior history of myocardial infarction or heart failure, or those who do not have visible plaque in major coronary arteries.
Why it matters
Potential benefit: If successful, this study could provide a more accurate and non-invasive method for assessing cardiovascular risk, leading to better treatment outcomes for patients.
How similar studies have performed: Other studies have shown promise in using advanced imaging and AI for cardiovascular risk assessment, indicating that this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-80 years * Clinically significant angina pectoris, suspecting coronary artery disease Exclusion Criteria: * Unsuitable for coronary CTA (such as severe renal impairment, uncontrolled thyroid condition, allergic to iodine, etc.) * Without a visible plaque (defined as ≥ 30% stenosis) in major coronary arteries in coronary CTA * Prior history of myocardial infarction or heart failure * Prior history of percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) * Severe renal or liver failure * Familial hypercholesterolemia * Estimated survival ≤1 year * Malignant tumor * Poor coordinance, unable to follow-up
Where this trial is running
Cangzhou, Hebei and 8 other locations
- Cangzhou Center Hospital — Cangzhou, Hebei, China (Not_yet_recruiting)
- First affiliated hospital of Harbin Medical University — Harbin, Heilongjiang, China (Not_yet_recruiting)
- First affiliated hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
- Union Hospital, Tongji Medical College, Huazhong University of Science and Techonology — Wuhan, Hubei, China (Not_yet_recruiting)
- First Hospital of Nanjing — Nanjing, Jiangsu, China (Not_yet_recruiting)
- First affiliated hospital of Dalian Medical College — Dalian, Liaoning, China (Not_yet_recruiting)
- General Hospital of Northern Theater Command — Shenyang, Liaoning, China (Recruiting)
- Xinhua Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai, China (Not_yet_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, M.D., Ph.D.
- Email: xiaoqun_wang@hotmail.com
- Phone: +86 13651839760
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.