Glenfield Hospital
Leicester, Leics, LE3 (QP, United Kingdom
Location status: Recruiting
Location contact
Jayanth Arnold
CONTACT
Mo Elshibly
CONTACT
NCT Number: NCT04761991
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Leicester, Leics, LE3 (QP, United Kingdom
Location status: Recruiting
Jayanth Arnold
CONTACT
Mo Elshibly
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
multi-parametric CMR assessment and CT coronary angiography with FFR assessment
Time frame: 6 weeks
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.
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Diagnostic accuracy, sensitivity and specificity of CMR T1 mapping using invasive FFR as the reference standard (per patient and per vessel levels).
Time frame: 6 weeks
Diagnostic accuracy, sensitivity and specificity of hybrid CMR/CT-FFR using invasive FFR as the reference standard (per patient and per vessel levels).
Time frame: 6 weeks
Time frame: 2 years
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.
Time frame: 2 years
Prediction by imaging modalities of clinical endpoints (subsequent percutaneous and/or surgical revascularisation, admissions with acute coronary syndrome and cerebrovascular accident, all-cause mortality).
Time frame: 1 day
Subjective patient scan experience for CMR and CTCA.
Time frame: 1 day
Duration of each scan/scan component.
Time frame: 1 day
Image quality of each scan/scan component, assessed visually on a 4-point score - excellent (3), good (2), moderate (1) and poor (0).
Contact information is provided by the study sponsor or research team.
University of Leicester
Other
Comparison of Cardiovascular Magnetic Resonance and Computed Tomography With Fractional Flow Reserve in the Diagnosis of Suspected Coronary Artery Disease
Acronym: CONCORD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07720349
Arterial Occlusive Diseases, Arteriosclerosis
Arendal, Norway
View Trial DetailsNCT02038127
Arterial Occlusive Diseases, Arteriosclerosis
Chuncheon, Gangwon-do, South Korea
View Trial DetailsNCT07190690
Arterial Occlusive Diseases, Arteriosclerosis
Alicante, Spain
View Trial DetailsNCT05611307
ASCVD, Arterial Occlusive Diseases
Indianapolis, Indiana, United States
View Trial Details