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

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: CT/MR
* Procedure: Catheterization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT/MR<br>CT/MRI-directed clinical management strategy | Procedure: CT/MR<br>* CT/MRI-directed clinical management strategy<br>|
| Active Comparator: Catheterization<br>Standard clinical management | Procedure: Catheterization<br>* Standard clinical management directed by conventional coronary angiography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | 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). | during or up to 2 days after procedures | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hard Cardiovascular Events | 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. | Follow-up 3 (36-60 Months) | 
| Comparison of Contrast Induced Nephropathy | 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. | 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 | 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. | Follow-up 3 (36-60, Months) | 
| Comparison of In-Hospital Stay | to compare the in-hospital stay time and overall length of stay. | Up to 24 hours after the end of the in-hospital stay. | 
| Quality of Life Analysis | 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. | 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 | 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. | Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months) | 
| Comparison of Cost-effectiveness | To compare cost-effectiveness in both groups using the primary and secondary efficacy data, the QALY data, and cost data derived from the trial. | Follow-up 3 (36-60 Months) | 
| Comparison of Patient Preference | To analyze patient preference and satisfaction with the therapeutic management strategies with a focus on the comfort during the imaging tests. | 24 hours after last procedure related to computed tomography or conventional coronary angiography | 
| Comparison of the Amount of Contrast Agent | Comparison of the amount of contrast agent | 10 minutes after the examinations. | 
| Comparison of the Amount of Radiation Exposure | 10 minutes after computed tomography or conventional coronary angiography | Comparison of the amount of radiation exposure | 
| Analysis of Image Quality | To analyze which image quality in multislice computed coronary angiography would be required to directly reliably triage patients to coronary artery bypass grafting. | 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 | 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. | Up to 24 hours after the end of computed tomography | 
| Comparison of Biological Effects of Radiation Exposure | 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. | Z1) before exam, (Z2) 60 min after end of exam, (Z3) 18-24h after exam | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suspected coronary artery disease