The Diagnostic and Prognostic Value of Comprehensive Functional Assessments for Non-obstructive Coronary Artery Diseases.

Shanghai Zhongshan Hospital1 site in 1 country1,000 target enrollmentJanuary 1, 2018

ConditionsCoronary Artery Disease Myocardial Ischemia Coronary Microvascular Dysfunction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Shanghai Zhongshan Hospital
Enrollment: 1000
Locations: 1
Primary Endpoint: Major adverse cardiac events (MACE)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To validate and investigate the efficacy of comprehensive functional assessments for the diagnostic and prognostic value in NOCAD.

Registry

clinicaltrials.gov

Start Date

January 1, 2018

End Date

December 31, 2022

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Shanghai Zhongshan Hospital

Responsible Party

Principal Investigator

Junbo Ge

Professor

Shanghai Zhongshan Hospital

Eligibility Criteria

Inclusion Criteria

•visual evaluation of epicardial coronary artery diameter stenosis (DS%) ≤ 50%;
•CZT-SPECT was successfully conducted within three days of CAG

Exclusion Criteria

•had flow-limiting epicardial stenosis (DS% \>50%) or angiography-derived FFR (Angio-FFR) ≤ 0.8;
•severe valvular heart disease;
•chronic heart failure and/or left ventricular ejection fraction (LVEF) of \< 50%;
•cardiomyopathy and myocarditis;
•severe renal or hepatic insufficiency;
•failure in detecting SPECT;
•failure in computing Angio-IMR, and -FFR.

Outcomes

Primary Outcomes

Major adverse cardiac events (MACE)

Time Frame: 5 years

The composite of coronary heart disease death, nonfatal myocardial infarction, hospitalization for unstable angina, or fatal or nonfatal ischemic stroke.

Secondary Outcomes

Individual components of MACE(5 years)
the change in Seattle Angina Questionnaire (SAQ) summary score(5 years)
the change in Seattle Angina Questionnaire (SAQ) score of indivadual scale(5 years)