CMR Versus CT in Coronary Artery Disease

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Diagnostic Test: CMR and CTCA with CT-FFR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged ≥18 years Referred for invasive coronary angiography for investigation of chest pain Exclusion Criteria: 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 Second-/third-degree atrioventricular block Severe chronic obstructive pulmonary disease Moderate-severe asthma Estimated glomerular filtration rate <30 ml/min/1.73m2 Women who are pregnant, breast-feeding or of child-bearing potential( premenopausal women) Contraindication to iodinated contrast Participation in a research study involving an investigational product in the past 12 weeks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: CMR and CTCA with CT-FFR|multi-parametric CMR assessment and CT coronary angiography with FFR assessment|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks | 
| 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. | 6 weeks | 
| 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). | 6 weeks | 
| 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). | 6 weeks | 
| Diagnostic performance of strain assessment | 5. Diagnostic accuracy, sensitivity and specificity of CMR strain assessment (global/segmental longitudinal/circumferential strain, mechanical dispersion) using invasive FFR as the reference standard (per patient and per vessel levels). | 6 weeks | 
| 6. Cost analysis | Cost analysis to assess the long term costs of the different diagnostic testing strategies. Healthcare costs for each testing strategy - data on resource use (staff time, scan duration, hospital days and clinic visits) will be collected during the study period. | 2 years | 
| 7. Clinical endpoints | Prediction by imaging modalities of clinical endpoints (subsequent percutaneous and/or surgical revascularisation, admissions with acute coronary syndrome and cerebrovascular accident, all-cause mortality). | 2 years | 
| 8. Subjective experience | Subjective patient scan experience for CMR and CTCA. | 1 day | 
| 9. Time duration of each scan/scan component. | Duration of each scan/scan component. | 1 day | 
| 10. Image quality | Image quality of each scan/scan component, assessed visually on a 4-point score - excellent (3), good (2), moderate (1) and poor (0). | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, CT-FFR, coronary artery disease