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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University Hospital Muenster
Medizinische Hochschule Hannover, Eva Schönenberger, MD
University of Freiburg
Information provided by (Responsible Party):
Marc Dewey, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00844220
First received: February 13, 2009
Last updated: November 10, 2015
Last verified: November 2015
  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 ]
    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).


Secondary Outcome Measures:
  • Hard Cardiovascular Events [ Time Frame: Follow-up 3 (36-60 Months) ] [ Designated as safety issue: Yes ]
    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.

  • Comparison of Contrast Induced Nephropathy [ Time Frame: Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months) ] [ Designated as safety issue: No ]
    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.

  • Comparison of Comparison of Soft Cardiovascular Events [ Time Frame: Follow-up 3 (36-60, Months) ] [ Designated as safety issue: No ]
    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.

  • Comparison of In-Hospital Stay [ Time Frame: Up to 24 hours after the end of the in-hospital stay. ] [ Designated as safety issue: No ]
    to compare the in-hospital stay time and overall length of stay.

  • Quality of Life Analysis [ Time Frame: Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months) ] [ Designated as safety issue: No ]
    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.

  • Confounding Effects of Nutrition, Physical Activity, and Depression [ Time Frame: Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months) ] [ Designated as safety issue: No ]
    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.

  • Comparison of Cost-effectiveness [ Time Frame: Follow-up 3 (36-60 Months) ] [ Designated as safety issue: No ]
    To compare cost-effectiveness in both groups using the primary and secondary efficacy data, the QALY data, and cost data derived from the trial.

  • Comparison of Patient Preference [ Time Frame: 24 hours after last procedure related to computed tomography or conventional coronary angiography ] [ Designated as safety issue: No ]
    To analyze patient preference and satisfaction with the therapeutic management strategies with a focus on the comfort during the imaging tests.

  • Comparison of the Amount of Contrast Agent [ Time Frame: 10 minutes after the examinations. ] [ Designated as safety issue: No ]
    Comparison of the amount of contrast agent

  • Comparison of the Amount of Radiation Exposure [ Time Frame: Comparison of the amount of radiation exposure ] [ Designated as safety issue: No ]
    10 minutes after computed tomography or conventional coronary angiography

  • Analysis of Image Quality [ Time Frame: Up to 24 hours after the end of computed tomography ] [ Designated as safety issue: No ]
    To analyze which image quality in multislice computed coronary angiography would be required to directly reliably triage patients to coronary artery bypass grafting.

  • Analysis of Correlation and Agreement About the Stenosis Diameter Between Multislice Computed Coronary Angiography and Conventional Coronary Angiography [ Time Frame: Up to 24 hours after the end of computed tomography ] [ Designated as safety issue: No ]
    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.

  • Comparison of Biological Effects of Radiation Exposure [ Time Frame: Z1) before exam, (Z2) 60 min after end of exam, (Z3) 18-24h after exam ] [ Designated as safety issue: No ]
    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.


Enrollment: 340
Study Start Date: February 2009
Estimated Study Completion Date: September 2018
Primary Completion Date: September 2015 (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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Charité
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
University Hospital Muenster
Medizinische Hochschule Hannover, Eva Schönenberger, MD
University of Freiburg
Investigators
Principal Investigator: Marc Dewey, MD, PhD Charite University, Berlin, Germany
  More Information

Publications:
Responsible Party: Marc Dewey, Professor, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00844220     History of Changes
Other Study ID Numbers: EA1/080/08 
Study First Received: February 13, 2009
Last Updated: November 10, 2015
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 July 25, 2016