Risk Evaluation by COronary CTA and Artificial IntelliGence Based fuNctIonal analyZing tEchniques - II

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT05856110
• Lead Sponsor: Ruijin Hospital

Brief Summary

This study is a multicenter, prospective clinical cohort study. The study intends to continuously enroll patients with coronary heart disease. All subjects will undergo coronary CTA (followed by anatomic, functional and radiomics analysis), proteomics research as well as clinical follow-up of cardiovascular events. The purpose of this study is to establish a new, non-invasive cardiovascular disease risk stratification system.

Detailed Description

Coronary angiography has been the gold standard for the diagnosis of coronary heart disease and PCI decision-making. However, the value of CAG in risk stratification is limited due to its invasive nature and lack of ability to evaluate coronary physiology and plaque characteristics, which often leads to over-treatment or under-treatment. In recent years, with the development and improvement of imaging technology, the resolution and diagnostic accuracy of coronary artery CTA have been greatly improved, and the subsequent anatomy and function (non-invasive CT-FFR, etc.) have made the assessment of coronary artery lesion risk multi-dimensional. Comprehensive and accurate coronary artery CTA scan plays a positive role in establishing the appropriate standard for PCI and improving the prognosis of patients. However, the existing problems of coronary artery CTA are insufficient imaging studies, complex image analysis, inconsistent diagnostic criteria, and insufficient clinical evidence. This study is one of the series of clinical studies on the topic of "Risk Evaluation by COronary Computed Tomography and Artificial Intelligence Based fuNctIonal analyZing tEchniques (RECOGNIZE)". The purpose of the study is to evaluate the accuracy of early identification of cardiovascular high-risk groups based on the functional evaluation model based on coronary CTA images through a multi-center, prospective clinical cohort study, so as to establish an early, non-invasive and accurate risk classification of cardiovascular events in coronary heart disease.

Study Timeline

• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-04
• Study First Posted: 2023-05-12
• Study Start: 2023-07-03
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-06
• Last Update Posted: 2023-08-08
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiovascular Events	2 years	Including cardiovascular death, myocardial infarction, and stroke

Secondary Outcome Measures

Name	Time	Method
Myocardial infarction	2 years	Including STEMI and NSTEMI
Cardiovascular death	2 years	Death due to cardiovascular events
Stroke	2 years	Including ischemic and hemorrhagic stroke
Coronary Revascularization	2 years	Including percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

Trial Locations

Locations (9)

First affiliated hospital of Dalian Medical College; 🇨🇳 Dalian, Liaoning, China

First affiliated hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Cangzhou Center Hospital; 🇨🇳 Cangzhou, Hebei, China

First affiliated hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Techonology; 🇨🇳 Wuhan, Hubei, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, China

General Hospital of Northern Theater Command; 🇨🇳 Shenyang, Liaoning, China

First Hospital of Nanjing; 🇨🇳 Nanjing, Jiangsu, China

Xinhua Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China