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NCT Number: NCT04761991

CMR Versus CT in Coronary Artery Disease

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CMR and CTCA with CT-FFR

Diagnostic Test

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

Primary outcomes

  1. 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 outcomes

  1. 1. Diagnostic performance of CMR and CT-FFR

    Time frame: 6 weeks

    • 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. 2. Diagnostic performance of CMR and CT-FFR

    Time frame: 6 weeks

    • 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. 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. 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).

  5. Diagnostic performance of strain assessment

    Time frame: 6 weeks

    • 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. 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. 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. 8. Subjective experience

    Time frame: 1 day

    Subjective patient scan experience for CMR and CTCA.

  9. 9. Time duration of each scan/scan component.

    Time frame: 1 day

    Duration of each scan/scan component.

  10. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Jayanth Arnold

CONTACT

[email protected]

0300 303 1573

Mo Elshibly

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Collaborators

  • HeartFlow, Inc.
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Glasgow
  • University of Oxford

Registry information

Official study title

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

Acronym: CONCORD

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2021
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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