MODE SELECTION TRIAL IN SINUS NODE DYSFUNCTION (MOST)

窦房结功能障碍（大多数）的模式选择试验

• 批准号: 6283015
• 负责人: DEBORAH WILLIAMS
• 金额: $ 35.55万
• 依托单位: HOWARD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6283015
• 关键词: bradycardia; clinical research; corticosteroids; electronic pacemaker; human subject; human therapy evaluation; longitudinal human study; quality of life; tachycardia

The MOST project is an NIH-sponsored, multicenter, 5-year study in 2000 patients, designed with three, indivisible and equally important aims: 1) to determine whether an initial strategy for dual-chamber, rate-modulated (DDDR) pacing in all patients with sick sinus syndrome (SSS) improves event-free survival; 2) to determine whether patients randomized to DDDR pacing have a better quality of life than do patients randomized to ventricular, rate-modulated (VVIR) pacing, and 3) to determine if, after 1.5--4.5 years of longitudinal followup, DDDR pacing is more cost- effective than VVIR pacing. The primary endpoint of the study will be a composite clinical endpoint consisting of stroke or all-cause mortality. Total mortality and a composite endpoint consisting of the first occurrence of stroke, heart failure hospitalization, or death will constitute important secondary clinical endpoints. A Quality of Life (QOL) substudy is being conducted, in a randomly selected subset of 1400 patients, to provide data to reverse current practice patterns which appear to restrict access to dual chamber pacing in women and the aged. This QOL study targets women and the elderly to determine if DDDR pacing in superior in these two subgroups. Thus, MOST seeks to determine if the greater initial cost of DDDR pacemakers is offset by preventing adverse events and by improvement in quality of life (patient Benefits), and if DDDR pacing of all patients with SSS includes societal benefits (balancing the increased technological costs of DDDR pacing with potential long-term clinical savings).

MOST 项目是 2000 年由 NIH 资助的一项为期 5 年的多中心研究 患者，设计有三个不可分割且同等重要的目标：1) 确定是否采用双室速率调节的初始策略 所有病态窦房结综合征 (SSS) 患者的 (DDDR) 起搏均得到改善 无事件生存； 2) 确定患者是否随机分配至 DDDR 起搏的患者比随机接受起搏的患者有更好的生活质量 心室调速 (VVIR) 起搏，以及 3) 确定之后是否 1.5--4.5年纵向随访，DDDR起搏更成本- 比 VVIR 起搏有效。 该研究的主要终点将是 复合临床终点包括中风或全因死亡率。 总死亡率和由第一个组成的复合终点 发生中风、心力衰竭住院或死亡 构成重要的次要临床终点。 生活品质 (QOL) 子研究正在随机选择的 1400 人中进行 患者，提供数据来扭转当前的实践模式 似乎限制了女性和老年人使用双腔起搏的机会。 这项 QOL 研究针对女性和老年人，以确定 DDDR 起搏是否有效 在这两个亚组中处于优势。 因此，MOST 试图确定是否 DDDR 起搏器较大的初始成本可以通过预防不良反应来抵消 事件和生活质量的改善（患者福利），并且如果 所有 SSS 患者的 DDDR 起搏包括社会效益（平衡 DDDR 技术成本的增加与潜在的长期 临床节省）。