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| Name | Class |
|---|---|
| University Hospital Muenster | OTHER |
| Charite University, Berlin, Eva Schönenberger, MD | UNKNOWN |
| University of Freiburg | OTHER |
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The primary objective of this study is to analyze the clinical value of a therapeutic management strategy based on the results of coronary CT angiography and functional MRI. The clinical value of CT and MRI will be analyzed in patients with suspected coronary artery disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT/MR | Experimental | CT/MRI-directed clinical management strategy |
|
| Catheterization | Active Comparator | Standard clinical management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT/MR | Procedure | CT/MRI-directed clinical management strategy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Death, stroke, and myocardial infarction and moderate to severe groin hematoma, groin pain, infections, allergies, thromboses, and arteriovenous fistula or other complications (if prolonging the in-hospital stay significantly by at least 24 hours). | during or up to 2 days after procedures |
| Measure | Description | Time Frame |
|---|---|---|
| Hard Cardiovascular Events | Composite endpoint: The most important secondary outcome will be hard cardiovascular events at final follow-up (3 years). These hard events include: cardiac and noncardiac death (death from any cause), stroke, and myocardial infarction. These hard events are considered as major adverse cardiovascular events. | Follow-up 3 (36-60 Months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Dewey, MD, PhD | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20234975 | Background | Dewey M, de Vries H, de Vries L, Haas D, Leidecker C. The present and future of cardiac CT in research and clinical practice: moderated discussion and scientific debate with representatives from the four main vendors. Rofo. 2010 Apr;182(4):313-21. doi: 10.1055/s-0029-1245195. Epub 2010 Mar 16. | |
| 20725881 | Background |
| Label | URL |
|---|---|
| CAD-Man results | View source |
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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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| ID | Term |
|---|---|
| D002404 | Catheterization |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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| Catheterization |
| Procedure |
Standard clinical management directed by conventional coronary angiography |
|
| Comparison of Contrast Induced Nephropathy | To compare contrast-induced nephropathy (CIN) defined as increase in creatinine by 25% or 0.5 mg/dl from baseline at the measurements obtained 18 to 24 and/or 46 to 50 hours after the initial procedures as part of standard safety parameters performed at our institution. In addition, CIN will also be assessed during the follow-ups. | Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months) |
| Comparison of Comparison of Soft Cardiovascular Events | To compare soft cardiovascular events (unstable angina pectoris, re-revascularization, and first revascularization at least 2 months after randomization, according to the results of Ladenheim et al. J Am Coll Cardiol 1986, at final follow-up. | Follow-up 3 (36-60, Months) |
| Comparison of In-Hospital Stay | to compare the in-hospital stay time and overall length of stay. | Up to 24 hours after the end of the in-hospital stay. |
| Quality of Life Analysis | To analyze the change in quality of life (QALY) in both groups (prior to the tests and at follow-up) using the SF-12 and the EuroQuol as general measurement tools and the MacNew questionnaire as disease-specific questionnaire. | Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months) |
| Confounding Effects of Nutrition, Physical Activity, and Depression | To analyze the effect and potentially confounding effect of nutrition, physical activity (using the Freiburg questionnaire), and depression (assessed with the HADS questionnaire) in the two groups. | Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months) |
| Comparison of Cost-effectiveness | To compare cost-effectiveness in both groups using the primary and secondary efficacy data, the QALY data, and cost data derived from the trial. | Follow-up 3 (36-60 Months) |
| Comparison of Patient Preference | To analyze patient preference and satisfaction with the therapeutic management strategies with a focus on the comfort during the imaging tests. | 24 hours after last procedure related to computed tomography or conventional coronary angiography |
| Comparison of the Amount of Contrast Agent | Comparison of the amount of contrast agent | 10 minutes after the examinations. |
| Comparison of the Amount of Radiation Exposure | 10 minutes after computed tomography or conventional coronary angiography | Comparison of the amount of radiation exposure |
| Analysis of Image Quality | To analyze which image quality in multislice computed coronary angiography would be required to directly reliably triage patients to coronary artery bypass grafting. | Up to 24 hours after the end of computed tomography |
| Analysis of Correlation and Agreement About the Stenosis Diameter Between Multislice Computed Coronary Angiography and Conventional Coronary Angiography | To analyze the correlation and agreement between multislice computed coronary angiography and conventional coronary angiography (using quantitative analysis) for estimation of the percent diameter stenosis in patients who underwent both tests. | Up to 24 hours after the end of computed tomography |
| Comparison of Biological Effects of Radiation Exposure | To compare the biological effects of radiation exposure of ionizing radiation, measured by DNA double-strand breaks in lymphocytes, of CT and conventional coronary angiography themselves and in the two randomization groups (approval by ethics board for this substudy with start of first patient analyzed on September, 15, 2009). Blood samples are taken for double-strand break analysis. | Z1) before exam, (Z2) 60 min after end of exam, (Z3) 18-24h after exam |
| Zimmermann E, Dewey M. Whole-heart 320-row computed tomography: reduction of radiation dose via prior coronary calcium scanning. Rofo. 2011 Jan;183(1):54-9. doi: 10.1055/s-0029-1245629. Epub 2010 Aug 19. |
| 19704093 | Background | Dewey M, Zimmermann E, Deissenrieder F, Laule M, Dubel HP, Schlattmann P, Knebel F, Rutsch W, Hamm B. Noninvasive coronary angiography by 320-row computed tomography with lower radiation exposure and maintained diagnostic accuracy: comparison of results with cardiac catheterization in a head-to-head pilot investigation. Circulation. 2009 Sep 8;120(10):867-75. doi: 10.1161/CIRCULATIONAHA.109.859280. Epub 2009 Aug 24. |
| 21273517 | Background | Dewey M. Coronary CT versus MR angiography: pro CT--the role of CT angiography. Radiology. 2011 Feb;258(2):329-39. doi: 10.1148/radiol.10100161. No abstract available. |
| 21232705 | Background | Schoenhagen P, Nagel E. Noninvasive assessment of coronary artery disease anatomy, physiology, and clinical outcome. JACC Cardiovasc Imaging. 2011 Jan;4(1):62-4. doi: 10.1016/j.jcmg.2010.11.002. No abstract available. |
| 27777234 | Result | Dewey M, Rief M, Martus P, Kendziora B, Feger S, Dreger H, Priem S, Knebel F, Bohm M, Schlattmann P, Hamm B, Schonenberger E, Laule M, Zimmermann E. Evaluation of computed tomography in patients with atypical angina or chest pain clinically referred for invasive coronary angiography: randomised controlled trial. BMJ. 2016 Oct 24;355:i5441. doi: 10.1136/bmj.i5441. |
| 31864987 | Result | Bosserdt M, Feger S, Rief M, Preuss D, Ibes P, Martus P, Kofoed KF, Laule M, Perez I, Dewey M. Performing Computed Tomography Instead of Invasive Coronary Angiography: Sex Effects in Patients With Suspected CAD. JACC Cardiovasc Imaging. 2020 Mar;13(3):888-889. doi: 10.1016/j.jcmg.2019.10.014. Epub 2019 Dec 18. No abstract available. |
| 40411549 | Derived | Bosserdt M, Mohamed M, Neumann K, Rieckmann N, Dreger H, Brodszky V, Hofer S, Reinhold T, Mielke AM, Dewey M. Cost-utility of computed tomography in patients with atypical chest pain clinically referred for invasive coronary angiography: randomised controlled trial. Eur Radiol. 2025 Nov;35(11):6719-6734. doi: 10.1007/s00330-025-11692-0. Epub 2025 May 24. |
| 35090035 | Derived | Bosserdt M, Martus P, Tauber R, Dreger H, Dewey M, Schonenberger E; CAD-Man Study Group Investigators. Serum creatinine baseline fluctuation and acute kidney injury after intravenous or intra-arterial contrast agent administration-an intraindividual comparison as part of a randomized controlled trial. Nephrol Dial Transplant. 2022 May 25;37(6):1191-1194. doi: 10.1093/ndt/gfac013. No abstract available. |
| 31264950 | Derived | Schonenberger E, Martus P, Bosserdt M, Zimmermann E, Tauber R, Laule M, Dewey M. Kidney Injury after Intravenous versus Intra-arterial Contrast Agent in Patients Suspected of Having Coronary Artery Disease: A Randomized Trial. Radiology. 2019 Sep;292(3):664-672. doi: 10.1148/radiol.2019182220. Epub 2019 Jul 2. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |