Comprehensive Functional Assessments for NOCAD

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

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

Conditions
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Coronary Artery Disease, Myocardial Ischemia, Coronary Microvascular Dysfunction

Intervention / Treatment
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* Device: coronary physiological indices


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NCF cohort<br>Normanl coronary-flow patients referred to coronary angiography and undergo assessment with single photon emission computed tomography imaging (SPECT). | Device: coronary physiological indices<br>* coronary physiological indices<br>|
| CSF cohort<br>Coronary slow-flow patients referred to coronary angiography and undergo assessment with single photon emission computed tomography imaging (SPECT). | Device: coronary physiological indices<br>* coronary physiological indices<br>|
| ANOCA cohort<br>Angina with nonobstructive coronary artery patients referred to coronary angiography and undergo assessment with single photon emission computed tomography imaging (SPECT). | Device: coronary physiological indices<br>* coronary physiological indices<br>|
| INOCA cohort<br>Ischemia with nonobstructive coronary artery patients referred to coronary angiography and undergo assessment with single photon emission computed tomography imaging (SPECT). | Device: coronary physiological indices<br>* coronary physiological indices<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual components of MACE | Cumulative incidence of the individual components of MACE | 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. | 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. | 5 years |