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| Name | Class |
|---|---|
| University Hospital Tuebingen | OTHER |
| Siemens Medical Solutions | INDUSTRY |
| Bayer | INDUSTRY |
| University of Erlangen-Nürnberg |
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The purpose of this study is to determine the diagnostic accuracy of MPICT for the detection of hemodynamically relevant coronary stenosis (as determined by invasive FFR) in patients with suspected or known CAD clinically referred for invasive angiography.
Rationale: Cardiac computed tomography (CT) provides accurate assessment of the coronary arteries and detects significant coronary stenosis with high diagnostic accuracy. However, the hemodynamic relevance of these stenotic lesion remains unclear, although highly relevant for clinical decision-making. Recent technical developments with third-generation dual-source CT allow to determine myocardial perfusion during hyperemia and thus for assessment of the hemodynamic relevance of coronary lesions using a dynamic acquisition mode. To date, there is only very limited evidence of the feasibility of this approach stemming from single-center studies with varying standards of reference.
Objective: To determine the diagnostic accuracy of MPICT for the detection of hemodynamically relevant coronary stenosis (as determined by invasive FFR) in patients with suspected or known CAD clinically referred for invasive angiography. In an optional sub-study the diagnostic accuracy of MPICT for the detection of myocardial perfusion defects as determined by cardiac magnetic resonance imaging (CMRI) will be investigated.
Study design: Observational cohort study with fractional flow reserve (FFR) during invasive angiography as the reference standard.
Study population: Patients with known or suspected CAD clinically referred for invasive angiography.
Main study parameters: Myocardial perfusion defect on dynamic CT perfusion imaging, and diagnostic accuracy as compared invasive FFR.
Co Principle Investigators Koen Nieman MD PhD, Erasmus University Medical Center Fabian Bamberg MD PhD, University of Tübingen.
Investigators Valerie Schmidt-Honndorf PhD, University of Tübingen Tobias Geisler MD PhD, University of Tübingen Joost Daemen MD PhD, Erasmus University Medical Center Adriaan Coenen MD, Erasmus University Medical Center Stephan Achenbach MD PhD, Erlangen University Micheala M. Hell MD, Erlangen University Rozemarijn Vliegenthart MD PhD, UMC Groningen Pim van der Harst MD PhD, UMC Groningen Francesca Pugliese MD PhD, Queen Mary University of London Kakuya Kitagawa MD PhD, Mie University Hatem Alkadhi MD PhD, University Hospital Zurich, Switzerland Robert Manka MD PhD, University Hospital Zurich, Switzerland
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic detection of coronary artery disease | Other | Myocardial perfusion defect on dynamic CT perfusion imaging, and diagnostic accuracy as compared invasive FFR. |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial perfusion | invasive fractional flow reserve measurement | For each patient within 4 weeks of the CT perfusion acquisition |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of myocardial perfusion defect on MPIMRI | For each patient within 1 week before invasive fractional flow reserve measurement | |
| Per patient assessment of hemodynamically significant CAD | For each patient within 4 weeks of the CT perfusion acquisition |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with know or suspect coronary artery diseased, referred for invasive coronary angiography.
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| Name | Affiliation | Role |
|---|---|---|
| Koen Nieman, MD PHD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ErasmusMC | Rotterdam | South Holland | 3015CE | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39162632 | Derived | Soschynski M, Storelli R, Birkemeyer C, Hagar MT, Faby S, Schwemmer C, Nous FMA, Pugliese F, Vliegenthart R, Schlett CL, Nikolaou K, Krumm P, Nieman K, Bamberg F, Artzner CP. CT Myocardial Perfusion and CT-FFR versus Invasive FFR for Hemodynamic Relevance of Coronary Artery Disease. Radiology. 2024 Aug;312(2):e233234. doi: 10.1148/radiol.233234. | |
| 34538630 |
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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 |
| University Medical Center Groningen | OTHER |
| Mie University | OTHER |
| University Hospital, Zürich | OTHER |
| Queen Mary University of London | OTHER |
| University Hospital Munich | OTHER |
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| Ischemia per standardized myocardial segment | For each patient within 4 weeks of the CT perfusion acquisition |
| Coronary stenosis by CTA per territory (branch) | For each patient within 4 weeks of the CT perfusion acquisition |
| Coronary stenosis by invasive angiography per territory (branch) | For each patient within 4 weeks of the CT perfusion acquisition |
| Demographics. | For each patient within 1 week before invasive fractional flow reserve measurement |
| Cardiovascular risk factors | For each patient within 1 week before invasive fractional flow reserve measurement |
| 'Image quality, based on the DICOM images measured by experienced readers." | Through study completion, an average of 1 to 2 years |
| Nous FMA, Geisler T, Kruk MBP, Alkadhi H, Kitagawa K, Vliegenthart R, Hell MM, Hausleiter J, Nguyen PK, Budde RPJ, Nikolaou K, Kepka C, Manka R, Sakuma H, Malik SB, Coenen A, Zijlstra F, Klotz E, van der Harst P, Artzner C, Dedic A, Pugliese F, Bamberg F, Nieman K. Dynamic Myocardial Perfusion CT for the Detection of Hemodynamically Significant Coronary Artery Disease. JACC Cardiovasc Imaging. 2022 Jan;15(1):75-87. doi: 10.1016/j.jcmg.2021.07.021. Epub 2021 Sep 15. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |