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

NCT06030596 | Unknown DMC

• 1 other identifier: SPECT MBFQ Trial II
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

SPECT; Myocardial Blood Flow; Myocardial Flow Reserve

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

coronary artery disease

Suspected or known coronary artery disease

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Suspected or known CAD

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Wei Fang, MD/PhD

  Fuwai Hospital, Beijing, China

  STUDY CHAIR

Central Study Contacts

Lei Wang, MD/PhD

CONTACT

861088322728; leiwangfw@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 11, 2023
• Study Start: September 9, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)