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CMR Versus CT in Coronary Artery Disease

Sponsor: University of Leicester

NCT ID: NCT04761991

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
CMR and CTCA with CT-FFR (diagnostic test)
How long the study runs
Study runs about 60 months (dates as stated)
About the drug or intervention
CMR and CTCA with CT-FFR — diagnostic test: multi-parametric CMR assessment and CT coronary angiography with FFR assessment
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
300
Started
2020-11-05
Last checked
2025-06

Plain English Summary

What is this study?

  • • Testing a new treatment for coronary artery disease
  • • Clinical study - 300 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with coronary artery disease

Where?

  • • Leicester - Glenfield Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Coronary Artery Disease

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

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

Who cannot take part

  • ✗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
See the full criteria
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

Where Is This Study? (1 UK site)

Glenfield Hospital

Leicester LE3 (QP, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Jayanth Arnold

Sponsor contact

CONTACT

0300 303 1573 jra14@le.ac.uk

Mo Elshibly

Sponsor contact

CONTACT

mmme1@le.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-06