CMR Versus CT in Coronary Artery Disease (CONCORD)

University of Leicester

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Diagnostic Test: CMR and CTCA with CT-FFR

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT04761991

1ZIAHL006242-02 (U.S. NIH Grant/Contract)

0726/258996

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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