Comprehensive Functional Assessments for NOCAD

Completed

• Conditions: Coronary Artery Disease; Myocardial Ischemia; Coronary Microvascular Dysfunction
• Interventions: Device: coronary physiological indices

• Registration Number: NCT06175572
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-31
• Status Verified: 2023-12
• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-17
• Last Update Submitted: 2023-12-17
• Study First Posted: 2023-12-19
• Last Update Posted: 2023-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CSF cohort	coronary physiological indices	Coronary slow-flow patients referred to coronary angiography and undergo assessment with single photon emission computed tomography imaging (SPECT).
ANOCA cohort	coronary physiological indices	Angina with nonobstructive coronary artery patients referred to coronary angiography and undergo assessment with single photon emission computed tomography imaging (SPECT).
INOCA cohort	coronary physiological indices	Ischemia with nonobstructive coronary artery patients referred to coronary angiography and undergo assessment with single photon emission computed tomography imaging (SPECT).
NCF cohort	coronary physiological indices	Normanl coronary-flow patients referred to coronary angiography and undergo assessment with single photon emission computed tomography imaging (SPECT).

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events (MACE)	5 years	The composite of coronary heart disease death, nonfatal myocardial infarction, hospitalization for unstable angina, or fatal or nonfatal ischemic stroke.

Secondary Outcome Measures

Name	Time	Method
Individual components of MACE	5 years	Cumulative incidence of the individual components of MACE
the change in Seattle Angina Questionnaire (SAQ) summary score	5 years	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.
the change in Seattle Angina Questionnaire (SAQ) score of indivadual scale	5 years	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.

Trial Locations

Locations (1)

Zhongshan hospital, Fudan university; 🇨🇳 Shanghai, China