BYPASS ANGIOPLASTY REVASCULARIZATION INVESTIGATION

旁路血管成形术血运重建研究

• 批准号: 3553041
• 负责人: MICHAEL V HERMAN
• 金额: $ 2.16万
• 依托单位: NEW YORK MEDICAL COLLEGE
• 依托单位国家: 美国
• 财政年份: 1987
• 资助国家: 美国
• 起止时间: 1987-06-01 至 1993-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3553041
• 关键词: angina pectoris; angiocardiography; cardiovascular stress test; coronary bypass; heart catheterization; human subject; human therapy evaluation; intraluminal angioplasty; longitudinal human study; patient /disease registry

The Bypass Angioplasty Revascularization Investigation (BARI) is a collaborative, randomized, multicenter clinical trial designed to assess the relative efficacy of percutaneous transluminal coronary angioplasty (PTCA) and coronary artery bypass graft (CABG) surgery in patients who require invasive therapy and have coronary anatomy suitable for either procedure. This study will require seven years for completion including phases of one year for protocol development and refinement, two years for patient recruitment, four years for patient follow-up and one year for close-out of the clinical units, data coordinating center and radiographic laboratory. All patients undergoing coronary arteriography at collaborating clinical units because of severe or unstable angina pectoris with or without antecedent myocardial infarction, will be asked to participate in the BARI registry. All patients who qualify, have their attending physician's consent, and satisfy the to be determined inclusion and exclusion criteria of the trial, will be randomized for therapy either with PTCA or CABG. These patients will then be followed for a period of not less than four years utilizing a primary end-point of death and secondary end-points of myocardial infarction, congestive heart failure and recurrent angina pectoris to compare these two groups.

旁路血管成形术血运重建调查(BARI)是一项 协作性、随机、多中心临床试验旨在评估 经皮冠状动脉腔内成形术的相对疗效 (PTCA)和冠状动脉旁路移植术(CABG)的患者 需要侵入性治疗，且冠状动脉解剖适用于 程序。这项研究将需要七年时间完成，包括 协议的制定和完善分一年进行，两年进行 患者招募，患者随访四年，一年 关闭临床单元、数据协调中心和X线片 实验室。所有接受冠状动脉造影术的患者 因严重或不稳定型心绞痛而协作临床单位 无论有无既往心肌梗死，都将被要求 参与BARI注册。所有符合条件的患者，都有他们的 主治医生同意，并满足待定纳入 和试验的排除标准，将随机进行治疗 经皮冠状动脉腔内成形术或冠状动脉搭桥术。然后，这些患者将被跟踪一段时间 不少于四年，使用主要死亡终点和 心肌梗死、充血性心力衰竭和 比较两组复发性心绞痛的疗效。