Dynamic CT Perfusion for Functional Assessment of Coronary Artery Disease

• Conditions: Coronary Artery Disease
• Interventions: Diagnostic Test: Dynamic cardiac CT perfusion imaging

• Registration Number: NCT04712513
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

The objective of this multicenter study is to evaluate the diagnostic accuracy of dynamic cardiac CT perfusion (CTP) imaging for non-invasive functional assessment of coronary artery disease (CAD). The proposed CTP technique allows concomitant assessment of two imaging-derived cardiac biomarkers including fractional flow reserve (FFR) and myocardial perfusion from a single dynamic imaging sequence, which facilities simultaneous evaluation of the hemodynamics in epicardial coronary arteries and coronary microcirculation in patients with CAD. The CTP results will be compared with invasive coronary angiography / FFR assessment and non-invasive cardiac magnetic resonance imaging (CMR) / radionuclide perfusion assessment.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-01-13
• Last Update Submitted: 2021-01-13
• Study First Posted: 2021-01-15
• Last Update Posted: 2021-01-15
• Study Start: 2021-03
• Primary Completion: 2023-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with coronary artery disease and hemodynamically stable	Dynamic cardiac CT perfusion imaging	-

Primary Outcome Measures

Name	Time	Method
Accuracy of myocardial perfusion obtained from dynamic cardiac CT perfusion imaging for detecting functionally significant coronary artery stenosis	Within 4 weeks prior to invasive cardiac catheterization	Comparison with invasive coronary angiography and FFR assessment
Comparison of diagnostic accuracy for functional CAD assessment between dynamic CT perfusion and static CT perfusion	Within 4 weeks prior to invasive cardiac catheterization	Comparison in patients with multi-vessel CAD where balanced ischemia is expected
Accuracy of combined myocardial perfusion and FFR measurement obtained from dynamic cardiac CT perfusion imaging for detecting functionally significant coronary artery stenosis	Within 4 weeks prior to invasive cardiac catheterization	Comparison with invasive coronary angiography and FFR assessment
Comparison of diagnostic accuracy for functional CAD assessment between dynamic CT perfusion and CT-FFR (based on computational fluid dynamics simulation)	Within 4 weeks prior to invasive cardiac catheterization	Comparison in patients with dense coronary calcification
Accuracy of FFR obtained from dynamic cardiac CT perfusion imaging for detecting functionally significant coronary artery stenosis	Within 4 weeks prior to invasive cardiac catheterization	Comparison with invasive coronary angiography and FFR assessment

Secondary Outcome Measures

Name	Time	Method
Comparison of diagnostic accuracy for functional CAD assessment between dynamic CT perfusion and other non-CT perfusion imaging techniques	Within 4 weeks of the acquisition of non-CT perfusion imaging	Comparison with CMR / radionuclide perfusion assessment
Comparison of diagnostic accuracy of dynamic CT perfusion for functional CAD assessment between male and female patients	Within 4 weeks prior to invasive cardiac catheterization	Sex-based analysis

Trial Locations

Locations (1)

St Joseph's Hospital; 🇨🇦 London, Ontario, Canada