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Clinical Trials/NCT05884008
NCT05884008
Recruiting
Not Applicable

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

Ruijin Hospital9 sites in 1 country300 target enrollmentMay 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Ruijin Hospital
Enrollment
300
Locations
9
Primary Endpoint
Coronary artery plaque risk level
Status
Recruiting
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2023
End Date
December 31, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

RUIYAN ZHANG

Director of Cardiology Department, Principal Investigator

Ruijin Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (9)

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