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

Coronary Artery Disease Clinical Trial

— RECOGNIZE-II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05856110
• Other study ID #: 2022YFC2533502-2
• Status: Recruiting
• Start date: July 3, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: Ruijin Hospital
• Contact: Xiaoqun Wang, M.D., Ph.D.
• Phone: +86 13651839760
• Email: xiaoqun_wang[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
China	Cangzhou Center Hospital	Cangzhou	Hebei
China	First affiliated hospital of Dalian Medical College	Dalian	Liaoning
China	First affiliated hospital of Harbin Medical University	Harbin	Heilongjiang
China	First Hospital of Nanjing	Nanjing	Jiangsu
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai
China	Xinhua Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	General Hospital of Northern Theater Command	Shenyang	Liaoning
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Techonology	Wuhan	Hubei
China	First affiliated hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiovascular Events	Including cardiovascular death, myocardial infarction, and stroke	2 years
Secondary	Cardiovascular death	Death due to cardiovascular events	2 years
Secondary	Myocardial infarction	Including STEMI and NSTEMI	2 years
Secondary	Stroke	Including ischemic and hemorrhagic stroke	2 years
Secondary	Coronary Revascularization	Including percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)	2 years