Coronary Artery Disease Management Using Multislice Computed Tomography and Magnetic Resonance Imaging
- Conditions
- Coronary Artery Disease
- Interventions
- Procedure: CT/MRProcedure: Catheterization
- Registration Number
- NCT00844220
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 340
- Suspected coronary artery disease and planned conventional coronary angiography based on atypical angina pectoris
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CT/MR CT/MR CT/MRI-directed clinical management strategy Catheterization Catheterization Standard clinical management
- Primary Outcome Measures
Name Time Method Complications 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).
- Secondary Outcome Measures
Name Time Method Hard Cardiovascular Events 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 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 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 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 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 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 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 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 10 minutes after the examinations. Comparison of the amount of contrast agent
Comparison of the Amount of Radiation Exposure Comparison of the amount of radiation exposure 10 minutes after computed tomography or conventional coronary angiography
Analysis of Image Quality 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 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 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.
Trial Locations
- Locations (1)
CharitƩ
š©šŖBerlin, Germany