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

August 6, 2023 updated by: RUIYAN ZHANG, Ruijin Hospital

Coronary Computed Tomography Angiography and Functional Analysis in Risk Stratification of Coronary Artery Disease: A Prospective, Multi-center Cohort Study

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.

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 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 Type

Observational

Enrollment (Estimated)

2000

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
      • 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.
    • Hebei
      • Cangzhou, Hebei, China
        • Not yet recruiting
        • Cangzhou Center Hospital
        • Contact:
          • Run Guo, M.D.
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Not yet recruiting
        • First Affiliated Hospital of Harbin Medical University
        • Contact:
          • Lei Liu, M.D.
    • Henan
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Yingying Zheng, M.D.
    • Hubei
      • Wuhan, Hubei, China
        • Not yet recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Techonology
        • Contact:
          • Tian Xie, M.D.
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Not yet recruiting
        • First Hospital of Nanjing
        • Contact:
          • Fei Ye, M.D.
    • Liaoning
      • Dalian, Liaoning, China
        • Not yet 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
        • Not yet 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 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.

Description

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 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
Major Adverse Cardiovascular Events
Time Frame: 2 years
Including cardiovascular death, myocardial infarction, and stroke
2 years

Secondary Outcome Measures

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

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: Geng Wang, M.D., The General Hospital of Northern Theater Command
  • Study Chair: 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., Wuhan Union Hospital, China
  • 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 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)

July 3, 2023

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

May 4, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 6, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022YFC2533502-2

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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