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
  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:


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:
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 April 17, 2014