Clinical trial NCT04761991: CMR Versus CT in Coronary Artery Disease
Official title: Comparison of Cardiovascular Magnetic Resonance and Computed Tomography With Fractional Flow Reserve in the Diagnosis of Suspected Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: MRI
CT-FFR
coronary artery disease
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: HeartFlow, Inc.
name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Oxford
name: University of Glasgow
First posted: 2021-02-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected coronary artery disease referred for invasive coronary angiography

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: 1. Diagnostic performance of CMR and CT-FFR
timeFrame: 6 weeks
Secondary outcomes:
measure: 1. Diagnostic performance of CMR and CT-FFR
timeFrame: 6 weeks
measure: 2. Diagnostic performance of CMR and CT-FFR
timeFrame: 6 weeks
measure: 3. Diagnostic performance of CMR T1 mapping
timeFrame: 6 weeks
measure: 4. Diagnostic performance of hybrid imaging
timeFrame: 6 weeks
measure: Diagnostic performance of strain assessment
timeFrame: 6 weeks
measure: 6. Cost analysis
timeFrame: 2 years
measure: 7. Clinical endpoints
timeFrame: 2 years
measure: 8. Subjective experience
timeFrame: 1 day
measure: 9. Time duration of each scan/scan component.
timeFrame: 1 day
measure: 10. Image quality
timeFrame: 1 day
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
state: Leics
Study officials:
References: