The PACE-MI Registry Study - Outcomes of Beta-blocker Therapy After Myocardial Infarction (OBTAIN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,057
- 试验地点
- 23
- 主要终点
- Total mortality at 2 years post myocardial infarction
研究概览
简要总结
The purpose of the PACE-MI (OBTAIN) registry is:
- Analyze beta-blocker dose response effect on outcome over two years
- Explore gender and minority differences in beta-blocker utilization and outcomes.
In patients with Myocardial Infarction (MI) discharged from the hospital, beta-blocker dose will be predictive of survival.
Exploratory analyses: Gender and racial effects-gender and race are, similarly, hypothesized to be predictive of post-MI survival.
The existence of interactions between gender and beta-blocker effect as well as race and beta-blocker effect will also be evaluated.
详细描述
Methods
All patients admitted to the coronary care areas with an acute myocardial infarction will be entered into the registry. At the time of discharge from the coronary care unit, clinical data will be entered. The registry will include approximately 6800 patients.
As there is no intervention in the registry, the data to be collected are standard for quality assurance purposes and cannot practicably be carried out without waivers of consent and HIPAA authorization, there will be no consent specifically for registry patients at baseline. Systems have been implemented to ensure the registry data will remain confidential. Sites have received IRB approval of waiver of consent and HIPAA for the baseline registry data.
Data to be collected will include demographic (including ethnic and race classifications according to NIH guidelines) data and information regarding the index myocardial infarction. Use of beta-blockers at discharge from the coronary care unit will be documented. In addition, beta-blocker use at hospital discharge will be noted. Data for the registry will be obtained from ER notes, admission notes, cardiac catheterization lab reports, medication lists, lab reports, and discharge summaries.
Follow-Up
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Total mortality at 2 years post myocardial infarction
时间窗: Measured at Years 1 and 2
Compare Kaplan Meier survival curves for the following 5 beta-blocker dose groups: No beta-blockers - 12.5% (\>0 - 12.5%) 25% (\>12.5 - 25%) - 50% (\>25 - 50%) Full Dose (\>50%)
次要结局
- Total mortality - secondary analysis(Measured at Year 1 and Year 2)
研究者
Jeff Goldberger
Principal Investigator, MD, MBA, Professor of Medicine
Northwestern University