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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 17, 2007 | ||||
| Last Updated Date | May 17, 2007 | ||||
| Start Date ICMJE | June 1996 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Graft patency will be assessed by angiography. 60% of patients will be catheterised between 7-10 years post surgery. [ Time Frame: 10 years from initial enrolment into the study ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Clinical · Onset of ischaemic chest pain · Acute myocardial infarct · Re-operation: coronary artery bypass grafting · Angioplasty · Stenting · Death [ Time Frame: 10 years from initial enrolment into the study ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Radial Artery Graft Patency Study | ||||
| Official Title ICMJE | The Department of Cardiac Surgery at Austin Health is Conducting a Prospective Randomised Trial, Comparing the Performance of the Radial Artery With the Currently Used Grafts in Patients Requiring Coronary Artery Bypass Grafts. | ||||
| Brief Summary | Coronary Artery Bypass Graft Surgery (CABGS) is commonly used to treat patients with coronary artery disease (atherosclerosis) for the relief of angina (chest pain) and improve heart muscle function. Healthy veins or arteries, referred to as ‘conduits’ from elsewhere in the patient's body are grafted (attached) from the aorta to the coronary arteries, bypassing (via new routes) coronary artery narrowings caused by atherosclerosis (hardening of the arteries) and thereby improving the blood supply to the myocardium (heart muscle). Over the years, a range of different veins and arteries from around the body have been used to bypass diseased coronary arteries. Typically, the saphenous veins from the legs and internal thoracic arteries from behind the breastbone are used for bypass. More recently, radial arteries from the forearm have also been used to bypass coronary arteries that are diseased (atherosclerotic). There is strong evidence to indicate that the left internal thoracic artery stays open the longest (i.e. has the highest patency) and achieves the best health outcomes. As a result, most cardiac surgeons use the left internal thoracic artery as their first choice of conduit (vessel used to bypass the blocked artery). However, many patients require multiple grafts and there is little evidence as to which grafts are best conduits to use. It has been suggested that the radial arteries might function better than saphenous veins as conduits. The Radial Artery Graft Study aims to compare patency of the radial arteries with saphenous veins and the right internal thoracic artery. |
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| Detailed Description | The Department of Cardiac Surgery at Austin Health is conducting a prospective randomised trial, comparing the performance of the radial artery with the right internal mammary artery and the saphenous vein graft, in patients requiring coronary artery bypass surgery. The study was first given approval by the Austin Health Human Research Ethics Committee in 1995 for a ten-year period. Enrolment commenced in March 1996. Recruitment ceased in March 2005. Patients were randomly assigned to the control or experimental group. Patients in both groups received the left internal thoracic artery as their first graft. Those in the control group received either a right internal thoracic artery or saphenous vein graft as their second graft. Those in the experimental group received a radial artery graft as their second graft. The gold standard measure for the comparison of conduits is through the use of post-operative angiograms. These angiograms assess how patent (open) the grafts are, and also offer quality assurance of the CABG surgery performed. The angiograms are randomly allocated/ scheduled at 1, 2, 5, 7.5 or 10 years after bypass surgery.Participants are also offered an elective coronary angiogram (or a Multi slice CT coronary angiogram scan, should they refuse the standard coronary angiogram) at 5 & 10 years after their surgery. Clinical data is systematically collected to determine those patients who experience heart attack, repeat surgery, balloon angioplasty or death over subsequent years. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Procedure: coronary angiogram or multi slice computed tomography scan | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Buxton BF, Raman JS, Ruengsakulrach P, Gordon I, Rosalion A, Bellomo R, Horrigan M, Hare DL. Radial artery patency and clinical outcomes: five-year interim results of a randomized trial. J Thorac Cardiovasc Surg. 2003 Jun;125(6):1363-71. | ||||
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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 | Active, not recruiting | ||||
| Enrollment ICMJE | 619 | ||||
| Estimated Completion Date | March 2015 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
GROUP 1 Specific exclusions
GROUP 2
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| Gender | Both | ||||
| Ages | 36 Years to 83 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Australia | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00475488 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | H2006/02690 | ||||
| Study Sponsor ICMJE | Austin Health | ||||
| Collaborators ICMJE | St Vincent | ||||
| Investigators ICMJE |
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| Information Provided By | Austin Health | ||||
| Verification Date | May 2007 | ||||
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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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