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NCT06030596 Clinical Trial

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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06030596
Other study ID # SPECT MBFQ Trial II
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 9, 2022
Est. completion date December 2023

Study information
Verified date September 2023
Source China National Center for Cardiovascular Diseases
Contact Lei Wang, MD/PhD
Phone 861088322728
Email leiwangfw@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 210
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 79 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Fuwai Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The diagnostic accuracy of MBF and MFR derived from SPECT 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. 1 year
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