CMR Versus CT in Coronary Artery Disease

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT04761991
• Lead Sponsor: University of Leicester

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 (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.

Study Timeline

• Study Start: 2020-11-05
• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2021-02-18
• Study First Posted: 2021-02-21
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-24
• Last Update Posted: 2023-11-29
• Primary Completion: 2025-06-05
• Study Completion: 2025-06-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Diagnostic performance of CMR and CT-FFR	6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
2. Diagnostic performance of CMR and CT-FFR	6 weeks	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. Cost analysis	2 years	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.
1. Diagnostic performance of CMR and CT-FFR	6 weeks	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.
3. Diagnostic performance of CMR T1 mapping	6 weeks	Diagnostic accuracy, sensitivity and specificity of CMR T1 mapping using invasive FFR as the reference standard (per patient and per vessel levels).
4. Diagnostic performance of hybrid imaging	6 weeks	Diagnostic accuracy, sensitivity and specificity of hybrid CMR/CT-FFR using invasive FFR as the reference standard (per patient and per vessel levels).
Diagnostic performance of strain assessment	6 weeks	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).
7. Clinical endpoints	2 years	Prediction by imaging modalities of clinical endpoints (subsequent percutaneous and/or surgical revascularisation, admissions with acute coronary syndrome and cerebrovascular accident, all-cause mortality).
8. Subjective experience	1 day	Subjective patient scan experience for CMR and CTCA.
9. Time duration of each scan/scan component.	1 day	Duration of each scan/scan component.
10. Image quality	1 day	Image quality of each scan/scan component, assessed visually on a 4-point score - excellent (3), good (2), moderate (1) and poor (0).

Trial Locations

Locations (1)

Glenfield Hospital; 🇬🇧 Leicester, Leics, United Kingdom