Risk Evaluation by COronary CTA & Artificial IntelliGence Based fuNctIonal

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05856110
Study type	Observational [Patient Registry]
Source	Ruijin Hospital
Contact	Xiaoqun Wang, M.D., Ph.D.
Phone	+86 13651839760
Email	xiaoqun_wang@hotmail.com
Status	Recruiting
Phase
Start date	July 3, 2023
Completion date	December 31, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms