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Completed

NCT Number: NCT06175572

Comprehensive Functional Assessments for NOCAD

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Coronary Microvascular Dysfunction Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan hospital, Fudan university

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

coronary physiological indices

Device

coronary physiological indices

Primary outcomes

  1. 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

  1. Individual components of MACE

    Time frame: 5 years

    Cumulative incidence of the individual components of MACE

  2. the change in Seattle Angina Questionnaire (SAQ) summary score

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Dec 19, 2023
Registry last updated
Dec 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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