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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06030596
Enrollment
210
Registered
2023-09-11
Start date
2022-09-09
Completion date
2023-12-31
Last updated
2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

SPECT, Myocardial Blood Flow, Myocardial Flow Reserve

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.

Interventions

None listed

Sponsors

China National Center for Cardiovascular Diseases
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The diagnostic accuracy of MBF and MFR derived from SPECT1 yearThe 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.

Countries

China

Contacts

Primary ContactLei Wang, MD/PhD
leiwangfw@126.com861088322728

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026