Coronary Artery Disease Management Using Multislice Computed Tomography and Magnetic Resonance Imaging

Brief Summary

Official Title: “Coronary Artery Disease Management Using Multislice Computed Tomography and Magnetic Resonance Imaging”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
  • Study Primary Completion Date: September 2015

Interventions Used in this Clinical Trial

  • Procedure: CT/MR
    • CT/MRI-directed clinical management strategy
  • Procedure: Catheterization
    • Standard clinical management directed by conventional coronary angiography

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: CT/MR
    • CT/MRI-directed clinical management strategy
  • Active Comparator: Catheterization
    • Standard clinical management

Outcome Measures for this Clinical Trial

Primary Measures

  • Complications
    • Time Frame: during or up to 2 days after procedures
      Safety Issue?: Yes

Secondary Measures

  • Hard Cardiovascular Events
    • Time Frame: Follow-up 3 (36-60 Months)
      Safety Issue?: Yes
  • 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)
      Safety Issue?: No
  • Comparison of Comparison of Soft Cardiovascular Events
    • Time Frame: Follow-up 3 (36-60, Months)
      Safety Issue?: No
  • Comparison of In-Hospital Stay
    • Time Frame: Up to 24 hours after the end of the in-hospital stay.
      Safety Issue?: No
  • Quality of Life Analysis
    • Time Frame: Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months)
      Safety Issue?: No
  • 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)
      Safety Issue?: No
  • Comparison of Cost-effectiveness
    • Time Frame: Follow-up 3 (36-60 Months)
      Safety Issue?: No
  • Comparison of Patient Preference
    • Time Frame: 24 hours after last procedure related to computed tomography or conventional coronary angiography
      Safety Issue?: No
  • Comparison of the Amount of Contrast Agent
    • Time Frame: 10 minutes after the examinations.
      Safety Issue?: No
  • Comparison of the Amount of Radiation Exposure
    • Time Frame: Comparison of the amount of radiation exposure
      Safety Issue?: No
  • Analysis of Image Quality
    • Time Frame: Up to 24 hours after the end of computed tomography
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • Comparison of Biological Effects of Radiation Exposure
    • Time Frame: Z1) before exam, (Z2) 60 min after end of exam, (Z3) 18-24h after exam
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Charite University, Berlin, Germany
  • Collaborator
    • University Hospital Muenster
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marc Dewey, Professor – Charite University, Berlin, Germany
  • Overall Official(s)
    • Marc Dewey, MD, PhD, Principal Investigator, Charite University, Berlin, Germany

References

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.

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.

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. doi: 10.1161/CIRCULATIONAHA.109.859280. 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. doi: 10.1148/radiol.10100161. Review.

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.

Source

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00844220