Comprehensive Functional Assessments for NOCAD

Shanghai Zhongshan Hospital1,000 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Coronary Artery Disease Myocardial Ischemia Coronary Microvascular Dysfunction

Interventions

coronary physiological indicesDEVICE

coronary physiological indices

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. visual evaluation of epicardial coronary artery diameter stenosis (DS%) ≤ 50%; 2. CZT-SPECT was successfully conducted within three days of CAG Exclusion Criteria: 1. had flow-limiting epicardial stenosis (DS% \>50%) or angiography-derived FFR (Angio-FFR) ≤ 0.8; 2. severe valvular heart disease; 3. chronic heart failure and/or left ventricular ejection fraction (LVEF) of \< 50%; 4. cardiomyopathy and myocarditis; 5. severe renal or hepatic insufficiency; 6. failure in detecting SPECT; 7. failure in computing Angio-IMR, and -FFR.

Locations (1)

Zhongshan hospital, Fudan university

Shanghai, China

Outcomes

Primary Outcomes

Major adverse cardiac events (MACE)

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

Time frame: 5 years

Secondary Outcomes

Individual components of MACE

Cumulative incidence of the individual components of MACE

Time frame: 5 years

the change in Seattle Angina Questionnaire (SAQ) summary score

The SAQ comprises 5 components namely physical limitation, angina stability, angina frequency, treatment satisfaction, and quality of life; these are then incorporated into the summary score. The higher the score, the better the patient's quality of life and physical function.

Time frame: 5 years

the change in Seattle Angina Questionnaire (SAQ) score of indivadual scale

The SAQ comprises 5 components namely physical limitation, angina stability, angina frequency, treatment satisfaction, and quality of life. The higher the score, the better the patient's quality of life or physical function.

Time frame: 5 years

Data from ClinicalTrials.gov

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