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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 20, 2006 | ||||
| Last Updated Date | October 12, 2006 | ||||
| Start Date ICMJE | January 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
All cause mortality perioperatively, one year, five and ten years. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00317265 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Combined cardiac death, non-fatal myocardial infarction and repeat revascularisation at one, five and ten years. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Coronary Bypass Surgery Trial: Complete Arterial Revascularization and Conventional Coronary Artery Surgery | ||||
| Official Title ICMJE | Complete Arterial Revascularization and Conventional Coronary Artery Surgery Study (CARACCASS)-European Multicenter Study | ||||
| Brief Summary | This is a randomized, prospective European Multicenter Study comparing complete arterial revascularization of the coronary arteries using arterial graft material exclusively and “conventional” coronary artery bypass surgery using the left internal thoracic artery as graft to the left anterior descending artery (LAD) and vein grafts to other vessels to be bypassed. |
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| Detailed Description | Coronary artery surgery effectively relieves angina and prolongs life in certain patient subsets. It is the most frequently performed major surgical procedure and therefore has profound economical impact. Unfortunately angina returns in 10 to 20 percent of patients by five years and in up to 50 percent at 10 years primarily because of graft failure and progression of atherosclerosis in the native coronary arteries. Serial angiography reveals that 15-30 percent of vein grafts are stenosed at one year and that nearly 50 percent are occluded at ten years. Recurrence of angina is associated with an increased risk of late myocardial infarction and reoperation. Reoperations after cardiac surgery carry a significantly increased risk of morbidity and mortality due to increased patient age, progression of coronary atherosclerosis, frequently reduced left ventricular function and technical difficulties. Thus prevention of restenosis by medical and surgical means is of eminent importance.The use of the IMA as a graft to the LAD is proven to reduce long-term mortality in patients after CABG throughout a 15 year follow-up period in all age groups. This data and the further improved survival with bilateral IMA grafting suggested by some have increased the interest of the surgical community in total arterial revascularization using both IMAs and various other arterial conduits. However to date there is no conclusive data demonstrating a clinical benefit of total arterial revascularization.Reports available on complete arterial revascularisation are either single institution / single surgeon, retrospective or non - randomized. Data on which we base our daily decision making is by and large from a different surgical period with different techniques used. Improved understanding of the pathogenic processes leading to graft occlusion have led to more rigorous use of antiplatelet drugs and lipid lowering which may significantly improve vein graft patency rates and slow or halt progression of native coronary artery atherosclerosis in the future. The scientific hypotheses underlying this randomized multicenter trial are:
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Coronary Artery Disease | ||||
| Intervention ICMJE | Procedure: Coronary bypass surgery | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 2000 | ||||
| Completion Date | January 2005 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 71 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Austria, Czech Republic, Germany, Norway, Poland, Spain, Sweden | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00317265 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | EK NR-348/98 | ||||
| Study Sponsor ICMJE | Medical University of Vienna | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Medical University of Vienna | ||||
| Verification Date | March 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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