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CMR Versus CT in Coronary Artery Disease

ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Leicester

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged ≥18 years

Referred for invasive coronary angiography for investigation of chest pain

Disqualifiers

Recent acute coronary syndrome (< 6 months)

Previous coronary artery bypass grafting

Severe claustrophobia

Absolute contraindications to CMR - those with MR conditional or safe devices will be included

Trial population

Patients with suspected coronary artery disease referred for invasive coronary angiography

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • CMR and CTCA with CT-FFR

    Diagnostic test

    multi-parametric CMR assessment and CT coronary angiography with FFR assessment

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

1. Diagnostic performance of CMR and CT-FFR

Diagnostic accuracy of CMR perfusion imaging (quantitative and qualitative analysis) and CT-FFR to determine the presence/absence of significant coronary artery disease at the subject level when compared with invasive FFR.

Time frame
6 weeks

Secondary outcomes

1

1. Diagnostic performance of CMR and CT-FFR

1\. Sensitivity and specificity of CMR perfusion imaging (quantitative and qualitative analysis) and CT-FFR to determine the presence/absence of significant coronary artery disease at the subject level when compared with invasive FFR.

Time frame
6 weeks
2

2. Diagnostic performance of CMR and CT-FFR

2\. Diagnostic accuracy, sensitivity and specificity of CMR perfusion imaging (quantitative and qualitative analysis) and CT-FFR to determine the presence/absence of significant coronary artery disease at the vessel level when compared with invasive FFR.

Time frame
6 weeks
3

3. Diagnostic performance of CMR T1 mapping

Diagnostic accuracy, sensitivity and specificity of CMR T1 mapping using invasive FFR as the reference standard (per patient and per vessel levels).

Time frame
6 weeks
4

4. Diagnostic performance of hybrid imaging

Diagnostic accuracy, sensitivity and specificity of hybrid CMR/CT-FFR using invasive FFR as the reference standard (per patient and per vessel levels).

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Leicester

Lead sponsor

HeartFlow, Inc.

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

University of Oxford

Collaborator

University of Glasgow

Collaborator

Source ClinicalTrials.gov
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