Coronary Artery Disease Management Using Multislice Computed Tomography and Magnetic Resonance Imaging (CAD-Man)
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|ClinicalTrials.gov Identifier: NCT00844220|
Recruitment Status : Active, not recruiting
First Posted : February 16, 2009
Last Update Posted : September 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Procedure: CT/MR Procedure: Catheterization||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||340 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Coronary Artery Disease Management Using Multislice Computed Tomography and Magnetic Resonance Imaging|
|Actual Study Start Date :||February 18, 2009|
|Actual Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||September 2018|
CT/MRI-directed clinical management strategy
CT/MRI-directed clinical management strategy
Active Comparator: Catheterization
Standard clinical management
Standard clinical management directed by conventional coronary angiography
- Complications [ Time Frame: during or up to 2 days after procedures ]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).
- Hard Cardiovascular Events [ Time Frame: Follow-up 3 (36-60 Months) ]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) ]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) ]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. ]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) ]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) ]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) ]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 ]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. ]Comparison of the amount of contrast agent
- Comparison of the Amount of Radiation Exposure [ Time Frame: Comparison of the amount of radiation exposure ]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 ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00844220
|Berlin, Germany, 10117|
|Principal Investigator:||Marc Dewey, MD, PhD||Charite University, Berlin, Germany|