PACEmaker & Beta-Blocker Therapy Post-Myocardial Infarct

起搏器

• 批准号: 7295957
• 负责人: JEFFREY J GOLDBERGER
• 金额: $ 312.42万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-29 至 2013-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7295957
• 关键词: Acute myocardial infarction; Address; Adrenergic beta-Antagonists; Bradyarrhythmias; Bradycardia; Cardiac; Clinical; Clinical Treatment; Clinical Trials; Conflict (Psychology); Data; Defibrillators; Disease; Elderly; End Point; Enrollment; Event; Heart Block; Implant; Infarction; Living Costs; Medical; Medicare; Meta-Analysis; Minor Surgical Procedures; Myocardial; Myocardial Infarction; Operative Surgical Procedures; Outcome; Pacemakers; Patient Care; Patients; Peptidyl-Dipeptidase A; Policies; Population; Positioning Attribute; Primary Prevention; Quality of life; Randomized; Rate; Recommendation; Recurrence; Reporting; Rest; Risk; Sample Size; Site; Standards of Weights and Measures; Subgroup; Sudden Death; Testing; United States Centers for Medicare and Medicaid Services; cost effectiveness; implantation; improved; mortality; prophylactic; theories

DESCRIPTION (provided by applicant): The PACEmaker & Beta-Blocker Therapy Post-Myocardial Infarction (PACE-MI) Trial will investigate whether pacemaker facilitated beta blocker therapy decreases the combined endpoint of total mortality plus nonfatal reinfarction in patients who have suffered a myocardial infarction and have bradycardia contraindications to beta blockers. Currently, these patients are not treated with beta blockers due to the likelihood of developing potentially dangerous bradyarrhythmias from treatment. Because beta blockers are highly effective agents in reducing mortality and reinfarction post-myocardial infarction, particularly in high risk subgroups, there has been increasing emphasis on their use. The patients with bradycardia precluding beta blocker therapy could, in theory, be treated with beta blockers if a pacemaker is implanted first to provide backup rate support. As these patients have been routinely excluded from clinical trials, there is no direct data to support such a recommendation. The specific aim of the PACE-MI Trial is to test whether pacemaker facilitated beta blocker therapy after myocardial infarction confers a clinical advantage in this subgroup of patients. This aim will be accomplished in this multicenter clinical trial in which patients within one month of a myocardial infarction who have either bradycardia or heart block contraindications to beta blockers will be randomized to receive either standard therapy (which would not include a beta-blocker as these patients have contraindications) or standard therapy plus a pacemaker and beta-blocker. This specific aim has important implications in that it will: 1) Provide data to support (if the hypothesis is verified) a change in Medicare coverage policy; 2) Provide support for the treatment paradigm of pacemaker facilitated betablocker therapy; 3) Highlight the importance of beta blocker therapy even in the modern era of management of myocardial infarction, particularly in the currently under treated elderly population. The trial primary composite is total mortality plus nonfatal reinfarction. Patients enrolled in the trial will be followed for two years. The sample size will be 1124 patients who will be enrolled in 60 sites.

描述（由申请人提供）： 心肌梗死后起搏器和β受体阻滞剂治疗（PACE-MI）试验将调查起搏器辅助β受体阻滞剂治疗是否可以降低患有心肌梗塞且有心动过缓β受体阻滞剂禁忌症的患者的总死亡率和非致命性再梗塞的综合终点。目前，这些患者没有接受β受体阻滞剂治疗，因为治疗可能会导致潜在危险的缓慢性心律失常。由于β受体阻滞剂是降低心肌梗塞后死亡率和再梗塞的高效药物，特别是在高风险亚组中，因此它们的使用越来越受到重视。理论上，如果首先植入起搏器以提供备用心率支持，则无法接受β受体阻滞剂治疗的心动过缓患者可以接受β受体阻滞剂治疗。由于这些患者通常被排除在临床试验之外，因此没有直接数据支持这一建议。 PACE-MI 试验的具体目的是测试心肌梗死后起搏器促进 β 受体阻滞剂治疗是否在该亚组患者中具有临床优势。这一目标将在这项多中心临床试验中实现，在该试验中，患有心动过缓或心脏传导阻滞而对 β 受体阻滞剂有禁忌症的心肌梗塞一个月内的患者将被随机分配接受任一标准治疗（其中不包括 β 受体阻滞剂，因为这些有禁忌症的患者）或标准治疗加起搏器和β受体阻滞剂。这一具体目标具有重要意义，因为它将： 1) 提供数据支持（如果假设得到验证）医疗保险覆盖政策的变化； 2）为起搏器辅助β受体阻滞剂治疗的治疗范式提供支持； 3) 强调β受体阻滞剂治疗的重要性，即使在现代心肌梗塞治疗时代，特别是在目前治疗不足的老年人群中。试验的主要组合是总死亡率加上非致命性再梗塞。参加试验的患者将被跟踪两年。样本量为 1124 名患者，将在 60 个地点进行登记。