SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve

Sponsor

China National Center for Cardiovascular Diseases (Other)

Overall Status

Recruiting

CT.gov ID

NCT06030596

Collaborator

(none)

210

Enrollment

Location

14.7

Anticipated Duration (Months)

14.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Recent evidences have demonstrated improved diagnostic accuracy for detecting coronary artery disease (CAD) when myocardial blood flow (MBF) is quantified in absolute terms using single photon emission tomography (SPECT) compared to conventional myocardial perfusion imaging (MPI). However, there are no uniformly accepted cutoff values of MBF and MFR derived from SPECT for diagnosing hemodynamically significant CAD. Particularly, the diagnostic performance for quantitative SPECT has not been validated using fractional flow reserve (FFR). The aim of this prospective study is to determine optimal cutoff values of absolute MBF and MFR derived from NaI (Tl)-based SPECT and to evaluate the diagnostic efficacy of this quantitative technology utilizing invasive coronary angiography (ICA) in combination with FFR results as the reference standard in patients with suspected or known CAD.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease

Study Design

Study Type:

Observational

Anticipated Enrollment :

210 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve

Actual Study Start Date :

Sep 9, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
coronary artery disease Suspected or known coronary artery disease

Outcome Measures

Primary Outcome Measures

The diagnostic accuracy of MBF and MFR derived from SPECT [1 year]
The diagnostic sensitivity, specificity, accuracy of MBF and MFR derived from SPECT for the detection of hemodynamically significant coronary artery disease as defined by invasive coronary angiography in combination with fractional flow reserve measurements.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 ~ 79 years old
At least one CAD risk factor
Intermediate to high pre-test likelihood for CAD
Suspected or known CAD, clinically referred for invasive coronary angiography
Able and willing to comply with the study procedures
Written informed consent

Exclusion Criteria:

History or risk of severe bradycardia
History of myocardial infarction, dilated cardiomyopathy, hypertrophic cardiomyopathy, valve issue or congenital heart disease
Wheezing asthma or COPD
Known second- or third-degree AV block
Known hypersensitivity to dipyridamole or adenosine
Known coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) prior to screening
Breastfeeding or pregnancy
Claustrophobia or inability to lie still in a supine position
Unwillingness or inability to provide informed consent