Coronary Artery Disease Management Using Multislice Computed Tomography and Magnetic Resonance Imaging (CAD-Man)

This study is currently recruiting participants.

Verified April 2013 by Charite University, Berlin, Germany

Sponsor:

Collaborators:

Universitätsklinikum Münster, Judith Kandil, MD

Medizinische Hochschule Hannover, Eva Schönenberger, MD

University of Freiburg

Information provided by:

Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT00844220

First received: February 13, 2009

Last updated: May 2, 2013

Last verified: April 2013

History of Changes

Purpose

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.

Condition	Intervention
Coronary Artery Disease	Procedure: CT/MR Procedure: Catheterization

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic
Official Title:	Coronary Artery Disease Management Using Multislice Computed Tomography and Magnetic Resonance Imaging

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Coronary Artery Disease MRI Scans

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:

Complications [ Time Frame: during or up to 2 days after procedures ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Major adverse cardiovascular events at 12-month follow-up [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	320
Study Start Date:	February 2009
Estimated Study Completion Date:	June 2015
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CT/MR CT/MRI-directed clinical management strategy	Procedure: CT/MR CT/MRI-directed clinical management strategy
Active Comparator: Catheterization Standard clinical management	Procedure: Catheterization Standard clinical management directed by conventional coronary angiography

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00844220

Contacts

Contact: Marc Dewey, MD, PhD	+49 30 4505 27296	dewey@charite.de
Contact: Elke Zimmermann, MD	+49 30 4506 27357	elke.zimmermann@charite.de

Locations

Germany
Charité	Recruiting
Berlin, Germany, 10117
Contact: Marc Dewey, MD, PhD

Sponsors and Collaborators

Charite University, Berlin, Germany

Universitätsklinikum Münster, Judith Kandil, MD

Medizinische Hochschule Hannover, Eva Schönenberger, MD

University of Freiburg

More Information

Publications:

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. Epub 2010 Mar 16.

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. Epub 2010 Aug 19.

Dewey M, Zimmermann E, Deissenrieder F, Laule M, Dübel 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. Epub 2009 Aug 24.

Dewey M. Coronary CT versus MR Angiography: Pro CT--The Role of CT Angiography. Radiology. 2011 Feb;258(2):329-39. No abstract available.

Schoenhagen P, Nagel E. Noninvasive assessment of coronary artery disease anatomy, physiology, and clinical outcome. JACC Cardiovasc Imaging. 2011 Jan;4(1):62-4. No abstract available.

Responsible Party:	Marc Dewey, Charité
ClinicalTrials.gov Identifier:	NCT00844220 History of Changes
Other Study ID Numbers:	EA1/080/08
Study First Received:	February 13, 2009
Last Updated:	May 2, 2013
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:

Suspected coronary artery disease

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases

Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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