Clinical trial NCT00844220: Coronary Artery Disease Management Using Multislice Computed Tomography and Magnetic Resonance Imaging
Official title: Coronary Artery Disease Management Using Multislice Computed Tomography and Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Suspected coronary artery disease
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: University Hospital Muenster
name: Charite University, Berlin, Eva Schönenberger, MD
name: University of Freiburg
First posted: 2009-02-16
Enrollment: 340
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Suspected coronary artery disease and planned conventional coronary angiography based on atypical angina pectoris

Exclusion Criteria:

* Known coronary artery disease
* ST elevation
* Age below 30 years
* Women of child-bearing potential without a negative pregnancy test
* Inclusion in another study
* Heart rate above 70 beats per min and contraindications to beta blockers
* Atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block
* Inability to hold the breath for 10 s

Primary outcomes:
measure: Complications
timeFrame: during or up to 2 days after procedures
Secondary outcomes:
measure: Hard Cardiovascular Events
timeFrame: Follow-up 3 (36-60 Months)
measure: Comparison of Contrast Induced Nephropathy
timeFrame: Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months)
measure: Comparison of Comparison of Soft Cardiovascular Events
timeFrame: Follow-up 3 (36-60, Months)
measure: Comparison of In-Hospital Stay
timeFrame: Up to 24 hours after the end of the in-hospital stay.
measure: Quality of Life Analysis
timeFrame: Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months)
measure: Confounding Effects of Nutrition, Physical Activity, and Depression
timeFrame: Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months)
measure: Comparison of Cost-effectiveness
timeFrame: Follow-up 3 (36-60 Months)
measure: Comparison of Patient Preference
timeFrame: 24 hours after last procedure related to computed tomography or conventional coronary angiography
measure: Comparison of the Amount of Contrast Agent
timeFrame: 10 minutes after the examinations.
measure: Comparison of the Amount of Radiation Exposure
timeFrame: Comparison of the amount of radiation exposure
measure: Analysis of Image Quality
timeFrame: Up to 24 hours after the end of computed tomography
measure: Analysis of Correlation and Agreement About the Stenosis Diameter Between Multislice Computed Coronary Angiography and Conventional Coronary Angiography
timeFrame: Up to 24 hours after the end of computed tomography
measure: Comparison of Biological Effects of Radiation Exposure
timeFrame: Z1) before exam, (Z2) 60 min after end of exam, (Z3) 18-24h after exam
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité
Study officials:
affiliation: Charite University, Berlin, Germany
name: Marc Dewey, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.