CMR Versus CT in Coronary Artery Disease

NCT ID: NCT04761991

Last Updated: 2025-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-05

Study Completion Date

2025-11-30

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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CMR and CTCA with CT-FFR

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HeartFlow, Inc.

INDUSTRY

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role collaborator

University of Glasgow

OTHER

Sponsor Role collaborator

University of Leicester

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Glenfield Hospital

Leicester, Leics, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Jayanth Arnold

Role: CONTACT

0300 303 1573

Mo Elshibly

Role: CONTACT

Facility Contacts

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Jayanth Arnold

Role: primary

0300 303 1573

Mo Elshibly

Role: backup

0300 303 1573

References

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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. CMR versus CCTA with fractional flow reserve for diagnosing obstructive coronary artery disease in higher risk patients: rationale and design of CONCORD - a prospective, single-centre diagnostic accuracy study. J Cardiovasc Magn Reson. 2025 Aug 14:101939. doi: 10.1016/j.jocmr.2025.101939. Online ahead of print.

Reference Type DERIVED
PMID: 40818667 (View on PubMed)

Other Identifiers

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1ZIAHL006242-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0726/258996

Identifier Type: -

Identifier Source: org_study_id

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