Risk Evaluation by COronary CTA and Artificial intelliGence Based fuNctIonal analyZing tEchniques - I

NCT05884008 | Recruiting DMC

• 1 other identifier: 2022YFC2533502-1
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 9

Brief Summary

This study is a multicenter, retrospective imaging study. The study intends to retrospectively enroll patients with acute myocardial infarction who had received coronary CTA in a certain time-window before this event. All coronary CTA will be analyzed by anatomic, functional and radiomic analysis, assisted by artificial intelligence. The purpose of this study is to establish a coronary artery disease risk stratification system by coronary CTA.

Conditions

Coronary Artery Disease

Keywords

Coronary CTA; CT-FFR; Artificial Intelligence; Risk Stratification

Outcome Measures

Primary Outcomes (1)

• Coronary artery plaque risk level

  Coronary plaque risk was determined using an artificial intelligence (AI) guided risk stratification model based on Coronary CTA structural, functional and radiomic analysis.

  3 months to 5 years prior to acute myocardial infarction

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study is a retrospective imaging study. Clinical records and image of patients received coronary CT angiography 3 months to 5 years prior to acute coronary myocardial infarction from nine clinical centers across P.R. China will be gathered.

You may qualify if:

• Age between 18-80 years old
• Received coronary CT angiography 3 months to 5 years prior to acute coronary myocardial infarction. CCTA identified coronary atherosclerotic plaques with diameter stenosis ≥ 10%

You may not qualify if:

• Familial hypercholesterolemia
• Prior history of percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
• Prior history of myocardial infarction before the recent event
• Severe liver or renal insufficiency

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (9)

Cangzhou Center Hospital

Cangzhou, Hebei, China

RECRUITING

First affiliated hospital of Harbin Medical University

Harbin, Heilongjiang, China

RECRUITING

First affiliated hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Techonology

Wuhan, Hubei, China

RECRUITING

First Hospital of Nanjing

Nanjing, Jiangsu, China

RECRUITING

First affiliated hospital of Dalian Medical College

Dalian, Liaoning, China

RECRUITING

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

RECRUITING

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Xinhua Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ruiyan Zhang, M.D., Ph.D.

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Lin Lu, M.D., Ph.D.

  Ruijin Hospital

  STUDY CHAIR

Central Study Contacts

Xiaoqun Wang, M.D., Ph.D.

CONTACT

+86 13651839760; xiaoqun_wang@hotmail.com

Shuo Feng, M.D., Ph.D.

CONTACT

+86 15921388296; fengshuorv@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiology Department, Principal Investigator

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: June 1, 2023
• Study Start: May 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

CN (9)