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

NCT ID: NCT06030596

Last Updated: 2023-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-09

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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coronary artery disease

Suspected or known coronary artery disease

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Wei Fang

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei Fang, MD/PhD

Role: STUDY_CHAIR

Fuwai Hospital, Beijing, China

Locations

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Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Wang, MD/PhD

Role: CONTACT

861088322728

Facility Contacts

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Wei Fang, MD/PhD

Role: primary

Other Identifiers

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SPECT MBFQ Trial II

Identifier Type: -

Identifier Source: org_study_id

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