Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatments ct/mr, catheterization
Sponsor Charite University, Berlin, Germany
Collaborator University Hospital Muenster
Start date February 2009
End date September 2015
Trial size 340 participants
Trial identifier NCT00844220, EA1/080/08

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose diagnostic
Arm
(Experimental)
CT/MRI-directed clinical management strategy
ct/mr
CT/MRI-directed clinical management strategy
(Active Comparator)
Standard clinical management
catheterization
Standard clinical management directed by conventional coronary angiography

Primary Outcomes

Measure
Complications
time frame: during or up to 2 days after procedures

Secondary Outcomes

Measure
Hard Cardiovascular Events
time frame: Follow-up 3 (36-60 Months)
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)
Comparison of Comparison of Soft Cardiovascular Events
time frame: Follow-up 3 (36-60, Months)
Comparison of In-Hospital Stay
time frame: Up to 24 hours after the end of the in-hospital 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)
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)
Comparison of Cost-effectiveness
time frame: Follow-up 3 (36-60 Months)
Comparison of Patient Preference
time frame: 24 hours after last procedure related to computed tomography or conventional coronary angiography
Comparison of the Amount of Contrast Agent
time frame: 10 minutes after the examinations.
Comparison of the Amount of Radiation Exposure
time frame: Comparison of the amount of radiation exposure
Analysis of Image Quality
time frame: Up to 24 hours after the end of computed tomography
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
Comparison of Biological Effects of Radiation Exposure
time frame: Z1) before exam, (Z2) 60 min after end of exam, (Z3) 18-24h after exam

Eligibility Criteria

Male or female participants at least 30 years old.

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

Additional Information

Official title Coronary Artery Disease Management Using Multislice Computed Tomography and Magnetic Resonance Imaging
Principal investigator Marc Dewey, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Charite University, Berlin, Germany.