ISRCTN84091290已完成未知
A Randomised Controlled Trial Comparing Conventional Coronary Artery Bypass Graft Surgery with a Composite Arterial Graft Technique
Record Provided by the NHSTCT Register - 2006 Update - Department of Health0 个研究点目标入组 300 人开始时间: 2006年9月29日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •300 patients will be recruited and randomly allocated in equal proportions to elective composite graft or conventional coronary artery bypass graft surgery. No randomised trials have been performed on all age groups of patients undergoing elective bypass surgery using composite graft techniques versus conventional bypass graft surgery. A recent randomised study comparing Saphenous vein grafts and radial artery conduits included angiographic follow-up at 1 year. 4 Graft failure rates were comparable at around 15%. Assuming that LIMA failure rates are more favourable (2%) the proportion of failed distal anastomosis sites in 100 patients with 3 bottom ends would be 2 from LIMA failure and 30 from other conduits - a rate of 32/300 or 10%. For patients with 4 bottom ends the figures would be 47/400 or 12%. If there is an equal proportion of 3 and 4 graft cases then a failure rate of 11% can be assumed for the conventional surgery group. From this data, a sample size of 300 patients would provide a denominator of 3.5 x 300 = 1050 anastomoses. Assuming 90% of patients yield angiographic images at follow-up (allowing for death, failure to consent and angiographic problems) the study would have an 80% power to detect a failure rate of 17% in the composite group (alpha error =0.05). Power for the angina outcome has been presented at the Seattle Questionnaire. All patients who fulfill the eligibility criteria will be approached by the participating surgeons and will be screened for trial eligibility. A patient information sheet will also be provided. Only patients who provide written informed consent prior to the procedure may be included. A copy of the written consent will be stored in the medical records, the study file and a copy will be given to the patient. The investigator will sign in the case record form that informed written consent has been obtained and the date consent was obtained. Informed consent will involve individual discussion with the patient about the nature of the procedures in a language that is easy to comprehend. The potential risks and benefits will be explained to the patient and they will be given time to make a decision about participation. It will be made clear that there is a random allocation to the two groups (composite versus conventional coronary artery bypass graft surgery) and that the patient or the physician does not decide which group they are allocated. It will be made clear that the patient can withdraw at any time from the research and does not have to give an explanation and it will not affect their medical care in any way. It will be recommended that the patient is given 24 hours to think about participation and discussing with family, friends or other healthcare professionals before signing the consent form. Referral to a participating surgeon for isolated multi-vessel CABG with an intention to fashion at least three distal anastomosis sites.
排除标准
- •1. Any contraindication to trial entry based on the clinical judgment of the responsible surgeon eg anticipated difficulty in surgical access, surgery planned as an emergency CABG on admission, and patients on inotropic support or cardiogenic shock
- •2. Re-operation
- •3. Proposed surgical or other intervention on a cardiac valve, great vessel, myocardial substance or other cardiovascular structure
- •4. Previous CVA/TIA within the last 6 months
- •5. Significant problem with graft material eg inability to use IMA graft, or absence of graft conduit material
- •6. Intention to perform bilateral IMA pedicle grafts
- •7. High risk of complication from subsequent follow-up diagnostic cardiac catheterisation including peripheral vascular disease, established renal dysfunction (serum creatinine >200 µmol/L or functioning transplant), allergy to radiographic contrast and previous angiographic complication or difficulty.
- •8. Recent involvement in another study (past 30 days etc)
研究者
相似试验
已完成
不适用
A randomized controlled trial comparing conventional ESD versus ProKnife ESD with injective function for gastric lesions in porcine modelsGastric cancerJPRN-UMIN000044343Kyushu University68
已完成
不适用
A randomized controlled trial comparing conventional training to flipped learning in cardiopulmonary resuscitation in first year medical studentcardiac arrestJPRN-UMIN000014907niversity of Fukui Hospital110
已完成
3 期
A randomized controlled trial comparing conventional ESD versus ESD with countertraction for early colon tumorearly colon tumorJPRN-UMIN000039583Division of Gastroenterology and Hepatology, Department of Medicine Nihon University School of Medicine254
已完成
3 期
A randomized controlled trial comparing conventional ESD versus ESD with countertraction for superficial esophageal cancer (CONNECT-E trial)superficial esophageal cancerJPRN-UMIN000024080Shizuoka Cancer Center241
已完成
3 期
A randomized controlled trial comparing conventional ESD versus ESD with dental floss-clip traction for gastric epithelial neoplasia (CONNECT-G trial)Gastric epithelial neoplasiaJPRN-UMIN000018266Shizuoka Cancer Center640