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: 6310019
• 负责人: DEBORAH WILLIAMS
• 金额: $ 20.62万
• 依托单位: HOWARD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2001-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6310019
• 关键词: bradycardia; clinical research; corticosteroids; electronic pacemaker; human subject; human therapy evaluation; longitudinal human study; medical implant science; 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 and 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 women and the aged. This QOL study targets women and the elderly to determine if DDDR pacing is 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 of QOL (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项目是一项由美国国立卫生研究院（NIH）赞助的、在2000例患者中进行的为期5年的多中心研究，设计有三个不可分割且同等重要的目标：1）确定在所有病窦综合征（SSS）患者中采用双腔频率调制（DDDR）起搏的初始策略是否可提高无事件生存率; 2）确定随机接受DDDR起搏的患者是否比随机接受心室频率调节（VVIR）起搏的患者生活质量更好，以及3）确定是否，经过1.5-4.5年的纵向随访，DDDR起搏比VVIR起搏更具成本效益。 本研究的主要终点将是由卒中和全因死亡率组成的复合临床终点。 总死亡率和复合终点（包括首次发生卒中、心力衰竭住院或死亡）将构成重要的次要临床终点。 一项生活质量（QOL）子研究正在随机选择的1400例患者中进行，以提供数据来扭转目前似乎限制女性和老年人的实践模式。 本QOL研究针对女性和老年人，以确定DDDR起搏在这两个亚组中是否具有上级优势。因此，MOST试图确定DDDR起搏器的较高初始成本是否通过预防不良事件和改善QOL（患者受益）来抵消，以及所有SSS患者的DDDR起搏是否包括社会受益（平衡DDDR起搏增加的技术成本与潜在的长期临床节省）。