CMR Versus CT in Coronary Artery Disease

Coronary Artery Disease Clinical Trial

— CONCORD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04761991
• Other study ID #: 0726/258996
• Secondary ID: 1ZIAHL006242-02
• Status: Recruiting
• Start date: November 5, 2020
• Est. completion date: June 5, 2025

Study information

• Verified date: November 2023
• Source: University of Leicester
• Contact: Jayanth Arnold
• Phone: 0300 303 1573
• Email: jra14[@]le.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 5, 2025
• Est. primary completion date: June 5, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Diagnostic Test:
• CMR and CTCA with CT-FFR
multi-parametric CMR assessment and CT coronary angiography with FFR assessment

Locations

Country	Name	City	State
United Kingdom	Glenfield Hospital	Leicester	Leics

Sponsors (5)

Lead Sponsor	Collaborator
University of Leicester	HeartFlow, Inc., National Heart, Lung, and Blood Institute (NHLBI), University of Glasgow, University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks
Secondary	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.	6 weeks
Secondary	2. Diagnostic performance of CMR and CT-FFR	2. 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.	6 weeks
Secondary	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).	6 weeks
Secondary	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).	6 weeks
Secondary	Diagnostic performance of strain assessment	5. 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 weeks
Secondary	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.	2 years
Secondary	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).	2 years
Secondary	8. Subjective experience	Subjective patient scan experience for CMR and CTCA.	1 day
Secondary	9. Time duration of each scan/scan component.	Duration of each scan/scan component.	1 day
Secondary	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).	1 day