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| ID | Type | Description | Link |
|---|---|---|---|
| 1ZIAHL006242-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| HeartFlow, Inc. | INDUSTRY |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| University of Oxford | OTHER |
| University of Glasgow |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMR and CTCA with CT-FFR | Diagnostic Test | multi-parametric CMR assessment and CT coronary angiography with FFR assessment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 2. Diagnostic performance of CMR and CT-FFR |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with suspected coronary artery disease referred for invasive coronary angiography
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jayanth Arnold | Contact | 0300 303 1573 | jra14@le.ac.uk | |
| Mo Elshibly | Contact | mmme1@le.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glenfield Hospital | Recruiting | Leicester | Leics | LE3 (QP | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40818667 | Derived | 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. Cardiovascular magnetic resonance versus coronary computed tomography angiography with fractional flow reserve for diagnosing obstructive coronary artery disease in higher risk patients: rationale and design of CONCORD-A prospective, single-center diagnostic accuracy study. J Cardiovasc Magn Reson. 2026 Summer;28(1):101939. doi: 10.1016/j.jocmr.2025.101939. Epub 2025 Aug 14. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 8. Subjective experience | Subjective patient scan experience for CMR and CTCA. | 1 day |
| 9. Time duration of each scan/scan component. | Duration of each scan/scan component. | 1 day |
| 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 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |