Viewing Study NCT04761991



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Last Modification Date: 2024-10-26 @ 1:57 PM
Study NCT ID: NCT04761991
Status: RECRUITING
Last Update Posted: 2023-11-29
First Post: 2020-12-17

Brief Title: CMR Versus CT in Coronary Artery Disease
Sponsor: University of Leicester
Organization: University of Leicester

Study Overview

Official Title: Comparison of Cardiovascular Magnetic Resonance and Computed Tomography With Fractional Flow Reserve in the Diagnosis of Suspected Coronary Artery Disease
Status: RECRUITING
Status Verified Date: 2023-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CONCORD
Brief 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 c50 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
1ZIAHL006242-02 NIH None httpsreporternihgovquickSearch1ZIAHL006242-02