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

June 6, 2024 updated by: RUIYAN ZHANG, Ruijin Hospital

Coronary Computed Tomography Angiography and Functional Analysis in Risk Stratification of Coronary Artery Disease: A Retrospective Cohort Study

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.

Study Overview

Status

Recruiting

Conditions

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 establish a coronary artery disease risk stratification system by coronary CTA and anatomic, functional and radiomic analysis, assisted by artificial intelligence.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hebei
      • Cangzhou, Hebei, China
        • Recruiting
        • CangZhou Center Hospital
        • Contact:
          • Run Guo, M.D.
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recruiting
        • First Affiliated Hospital of Harbin Medical University
        • Contact:
          • Lei Liu, M.D.
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Yingying Zheng, M.D.
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Techonology
        • Contact:
          • Tian Xie, M.D.
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • First Hospital of Nanjing
        • Contact:
          • Fei Ye, M.D.
    • Liaoning
      • Dalian, Liaoning, China
        • Recruiting
        • First affiliated hospital of Dalian Medical College
        • Contact:
          • Xiaolei Yang, M.D.
      • Shenyang, Liaoning, China
        • Recruiting
        • General Hospital of Northern Theater Command
        • Contact:
          • Geng Wang, M.D.
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital, Shanghai JiaoTong University School of Medicine
        • Sub-Investigator:
          • Shuo Feng, M.D.
        • Contact:
        • Principal Investigator:
          • Ruiyan Zhang, M.D., Ph.D.
        • Sub-Investigator:
          • Lin Lu, M.D., Ph.D.
        • Sub-Investigator:
          • Xiaoqun Wang, M.D., Ph.D.
        • Sub-Investigator:
          • Lili Liu, M.E.
      • Shanghai, Shanghai, China
        • Recruiting
        • Xinhua Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
          • Yachen Zhang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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%

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coronary artery plaque risk level
Time Frame: 3 months to 5 years prior to acute myocardial infarction
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Investigators

  • Principal Investigator: Ruiyan Zhang, M.D., Ph.D., Ruijin Hospital
  • Study Chair: Lin Lu, M.D., Ph.D., Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

May 4, 2023

First Submitted That Met QC Criteria

May 29, 2023

First Posted (Actual)

June 1, 2023

Study Record Updates

Last Update Posted (Actual)

June 7, 2024

Last Update Submitted That Met QC Criteria

June 6, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022YFC2533502-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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