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RecruitingNCT04761991

CMR Versus CT in Coronary Artery Disease

Comparison of Cardiovascular Magnetic Resonance and Computed Tomography With Fractional Flow Reserve in the Diagnosis of Suspected Coronary Artery Disease

Status
Recruiting
Phase
Study type
Observational
Enrollment
300 (estimated)
Sponsor
University of Leicester · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

CONCORD is a prospective observational study evaluating the diagnostic accuracy of cardiovascular magnetic resonance (CMR) and computed tomography with fractional flow reserve (CT-FFR) in patients with suspected coronary artery disease, using invasive fractional flow reserve (FFR) as the reference standard.

Detailed description

In patients with suspected coronary artery disease (CAD), CT coronary angiography (CTCA) provides excellent sensitivity and negative predictive value, enabling the safe exclusion of significant CAD. However, its positive predictive value remains suboptimal (c.50%). Undertaking additional CT-FFR improves specificity and positive predictive value, reducing unnecessary invasive coronary angiography. It has been established that CMR perfusion imaging offers excellent diagnostic accuracy for the identification of functionally significant coronary artery disease. The diagnostic performance of qualitative CMR perfusion assessment may be further enhanced by additional quantitative assessment. The purpose of this prospective observational study is to evaluate the diagnostic performance of all three modalities (CT-FFR and qualitative and quantitative CMR perfusion imaging), involving 300 patients with suspected coronary artery disease referred for invasive coronary angiography. A subset of 167 subjects will undergo an additional accelerated CMR scan for comparison. Invasively measured fractional flow reserve (FFR) will serve as the reference standard.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTCMR and CTCA with CT-FFRmulti-parametric CMR assessment and CT coronary angiography with FFR assessment

Timeline

Start date
2020-11-05
Primary completion
2025-11-30
Completion
2025-11-30
First posted
2021-02-21
Last updated
2025-07-01

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT04761991. Inclusion in this directory is not an endorsement.

CMR Versus CT in Coronary Artery Disease (NCT04761991) · Clinical Trials Directory