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Coronary Artery DiseaseCONCORDNCT04761991

CMR Versus CT in Coronary Artery Disease

An observational study of Coronary Artery Disease, run by University of Leicester at 1 site in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
CMR and CTCA with CT-FFR
How many people
300 participants
Where
1 siteUnited Kingdom
Study dates
5 Nov 2020to 30 Nov 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with suspected coronary artery disease referred for invasive coronary angiography

Who may be able to join

  • Patients aged ≥18 years
  • Referred for invasive coronary angiography for investigation of chest pain

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jayanth Arnold contact

0300 303 1573

jra14@le.ac.uk

Mo Elshibly contact

mmme1@le.ac.uk

United Kingdom1 site, 1 recruiting

  • Glenfield Hospital

    Leicester, Leics, LE3 (QP

    Jayanth Arnold, 0300 303 1573, jra14@le.ac.uk

    Mo Elshibly, 0300 303 1573, mmme1@le.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: Comparison of Cardiovascular Magnetic Resonance and Computed Tomography With Fractional Flow Reserve in the Diagnosis of Suspected 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.

Read the 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.

Being tested
CMR and CTCA with CT-FFR
Keywords
MRI, CT-FFR, coronary artery disease
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CMR and CTCA with CT-FFRDiagnostic test

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 weeks

Secondary outcomes (10)

  1. 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.

    Measured: 6 weeks

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

    1. 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.

    Measured: 6 weeks

  3. 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).

    Measured: 6 weeks

  4. 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).

    Measured: 6 weeks

  5. Diagnostic performance of strain assessment

    1. 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).

    Measured: 6 weeks

  6. 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.

    Measured: 2 years

  7. 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).

    Measured: 2 years

  8. 8. Subjective experience

    Subjective patient scan experience for CMR and CTCA.

    Measured: 1 day

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

    Duration of each scan/scan component.

    Measured: 1 day

  10. 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).

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2021
  2. Study start5 Nov 2020
  3. Primary completion30 Nov 2025 (estimated)
  4. Study completion30 Nov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04761991
Sponsor's protocol ID
0726/258996
Other IDs
1ZIAHL006242-02
Acronym
CONCORD
Status last verified
Jun 2025
First submitted
17 Dec 2020
Last updated
1 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shergill S, Elshibly M, Parke KS, England R, Wormleighton JV, Das I, Gulsin GS, Hothi SS, Heggie R, Wu O, Kellman P, McIntosh A, McConnachie A, Ladwiniec A, McCann GP, Arnold JR. Cardiovascular magnetic resonance versus coronary computed tomography angiography with fractional flow reserve for diagnosing obstructive coronary artery disease in higher risk patients: rationale and design of CONCORD-A prospective, single-center diagnostic accuracy study. J Cardiovasc Magn Reson. 2026 Summer;28(1):101939. doi: 10.1016/j.jocmr.2025.101939. Epub 2025 Aug 14.

    PubMed 40818667

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by University of Leicester at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jayanth Arnold (0300 303 1573, jra14@le.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1. Diagnostic performance of CMR and CT-FFR (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04761991, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.

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