Coronary Artery Disease
Conditions
Keywords
Suspected coronary artery disease
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.
Interventions
PROCEDURECT/MR
CT/MRI-directed clinical management strategy
PROCEDURECatheterization
Standard clinical management directed by conventional coronary angiography
Sponsors
University Hospital Muenster
Charite University, Berlin, Eva Schönenberger, MD
University of Freiburg
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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. |
Countries
Germany
Outcome results
None listed