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Comprehensive Functional Assessments for NOCAD

Fudan University logo

Fudan University

Status

Completed

Conditions

Coronary Artery Disease
Myocardial Ischemia
Coronary Microvascular Dysfunction

Treatments

Device: coronary physiological indices

Study type

Observational

Funder types

Other

Identifiers

NCT06175572
ZS20231202

Details and patient eligibility

About

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

Enrollment

1,000 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.

Trial design

1,000 participants in 4 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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