Comprehensive Functional Assessments for NOCAD

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06175572

Enrollment

1000

Registered

2023-12-19

Start date

2018-01-01

Completion date

2022-12-31

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Coronary Microvascular Dysfunction, Myocardial Ischemia

Brief summary

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

Interventions

DEVICEcoronary physiological indices

coronary physiological indices

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026