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

NCT05856110 | Unknown DMC

• 1 other identifier: 2022YFC2533502-2
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 9

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.

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiovascular Events

  Including cardiovascular death, myocardial infarction, and stroke

  2 years

Secondary Outcomes (4)

• Cardiovascular death

  2 years

• Myocardial infarction

  2 years

• Stroke

  2 years

• Coronary Revascularization

  2 years

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 multi-center cohort study. Patients with clinical angina pectoris and suspected coronary artery disease from nine clinical centers across P.R. China, including outpatient and hospitalized patients, are consecutively enrolled.

You may qualify if:

• Age 18-80 years
• Clinically significant angina pectoris, suspecting coronary artery disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (9)

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 Municipality, China

NOT YET RECRUITING

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200025, 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.

  Ruijin Hospital

  STUDY CHAIR

• Fei Ye, M.D.

  First Hospital of Nanjing

  STUDY CHAIR

• Yachen Zhang, M.D.

  Xinhua Hospital, Shanghai Jiaotong University School of Medicine

  STUDY CHAIR

• Tian Xie, M.D.

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

  STUDY CHAIR

• Lei Liu, M.D.

  First Affiliated Hospital of Harbin Medical University

  STUDY CHAIR

• Xiaolei Yang, M.D.

  The First Affiliated Hospital of Dalian Medical University

  STUDY CHAIR

• Run Guo, M.D.

  Cangzhou Center Hospital

  STUDY CHAIR

• Yingying Guo, M.D.

  The First Affiliated Hospital of Zhengzhou University

  STUDY CHAIR

• Geng Wang, M.D.

  The General Hospital of Northern Theater Command

  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: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiology, Director of cardiovascular catherization lab, Principle Investigator

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 12, 2023
• Study Start: July 3, 2023
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: August 8, 2023

Record last verified: 2023-08

Locations

CN (9)