FOLLOW-UP OF THE 1985-86 NHLBI PTCA REGISTRY

1985-86 年 NHLBI PTCA 登记的后续行动

• 批准号: 3552790
• 负责人: KATHERINE M DETRE
• 金额: $ 33.51万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 1984
• 资助国家: 美国
• 起止时间: 1984-12-01 至 1991-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3552790
• 关键词: angina pectoris; coronary disorder; disease /disorder proneness /risk; human morbidity; human mortality; human subject; human therapy evaluation; intraluminal angioplasty; longitudinal human study; patient /disease registry; relapse /recurrence

More than 100,000 patients received percutaneous transluminal coronary angioplasty (PTCA in 1985; more than 160,000 procedures are expected to be performed in 1986. Technical improvements in the procedure now enable cardiologists to treat patients with more extensive coronary disease. Data from the 1985-86 NHLBI PTCA Registry confirm that current patients have more extensive disease, more lesions dilated, more cardiovascular risk factors, yet better immediate results than the patients with less severe disease who received PTCA between 1977 and 1982. With a therapy being applied to such a large segment of the population, it is imperative to evaluate objectively its short-and long-term risks and benefits. To do this, we propose to follow the 1985-86 cohort of 2,000 patients for 5 years. Experienced clinical coordinators at 16 Registry sites will contact each patient yearly to establish clinically apparent recurrence, mortality, morbidity, symptoms, additional revascularizations (including angiographic results), and functional status. We expect to maintain our track record of over 96% follow-up. To strengthen the validity of inferences to be derived from the 1985-86 registry, we will introduce a number of quality control measures, including central, computerized evaluation of all pre-and post-PTCA angiograms, training sessions, site visits, quality control on a random sample of clinical data, and exchange of a 10% sample of pre-PTCA films among centers. Event rates obtained from this study will provide a realistic basis for the design of the NHLBI Bypass Angioplasty Revascularization Investigation (BARI) that will begin recruitment in 1988. We have been the Data Coordinating Center for the NHLBI Registry since 1980 and are currently conducting a follow-up of the 1977- 1982 cohort. The well established collaborative arrangements with each of the participating clinical investigators assure that the high level of productivity will continue to yield clinically relevant and scientifically valid new information.

超过10万名患者接受了经皮腔内注射 冠状动脉成形术(PTCA在1985年；超过160,000例手术 预计将于1986年上演。在技术方面的改进 该程序现在使心脏病专家能够治疗更多的患者 广泛的冠状动脉疾病。1985-86年NHLBI PTCA数据 登记证实，目前的患者有更广泛的疾病， 更多的病变扩大，更多的心血管危险因素，但更好 即刻效果比那些病情不那么严重的患者 在1977至1982年间接受PTCA。正在应用一种疗法 对于这么大一部分人口来说，必须 客观评估其短期和长期风险和收益。 为此，我们建议沿用一九八五至八六年度的2,000人 患者5年。16岁时担任经验丰富的临床协调员 注册网站将每年联系每个患者，以建立 临床上明显的复发、死亡率、发病率、症状、 其他血运重建(包括血管造影术结果)，以及 功能状态。我们希望保持我们的记录，超过 随访率为96%。为了加强推论的有效性， 根据一九八五至八六年度登记处的资料，我们会引入多项 质量控制措施，包括中央、计算机化 评估所有PTCA术前和术后的血管造影术、培训课程、 现场访问，对随机抽样的临床数据进行质量控制， 以及在中心之间交换10%的PTCA前薄膜样本。 这项研究得到的事件发生率将提供现实的基础 NHLBI旁路血管成形术血运重建的设计 调查(BARI)，将于1988年开始招募。 我们一直是NHLBI注册中心的数据协调中心 自1980年以来，目前正在进行1977年的后续行动- 1982年的队列。与中国建立了良好的合作安排 每个参与的临床研究人员都保证 高水平的生产力将继续在临床上产生 相关和科学有效的新信息。