CMR Versus CT in Coronary Artery Disease

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 5, 2025

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.

Interventions

  • Diagnostic Test: CMR and CTCA with CT-FFR
    • multi-parametric CMR assessment and CT coronary angiography with FFR assessment

Clinical Trial Outcome Measures

Primary Measures

  • 1. Diagnostic performance of CMR and CT-FFR
    • Time Frame: 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 Measures

  • 1. Diagnostic performance of CMR and CT-FFR
    • Time Frame: 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.
  • 2. Diagnostic performance of CMR and CT-FFR
    • Time Frame: 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.
  • 3. Diagnostic performance of CMR T1 mapping
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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).
  • 6. Cost analysis
    • Time Frame: 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.
  • 7. Clinical endpoints
    • Time Frame: 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
    • Time Frame: 1 day
    • Subjective patient scan experience for CMR and CTCA.
  • 9. Time duration of each scan/scan component.
    • Time Frame: 1 day
    • Duration of each scan/scan component.
  • 10. Image quality
    • Time Frame: 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Leicester
  • Collaborator
    • HeartFlow, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Jayanth Arnold, 0300 303 1573, jra14@le.ac.uk

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