NCT00605631已完成不适用
The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- LVEDV
研究概览
简要总结
This study is designed to evaluate the effect of pacing on post-MI patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or above, or of legal age to give informed consent specific to state and national law
- •Willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol
- •Patient has had a clinically documented anterior myocardial infarction which occurred within the last 14 days
- •Measured peak CK > 2000 mU/mL within 72 hours of MI.
- •QRS duration < 120 ms measured by 12-lead ECG at any time after most recent MI
排除标准
- •Patient has atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) or persistent (i.e., can be terminated with medical intervention, but does not terminate spontaneously) at time of enrollment
- •Patient is in cardiogenic shock defined by systolic blood pressure < 90 mmHg and on pressor/inotrope medications at time of potential enrollment
- •Patient has 2 or 3 degree heart block at time of potential enrollment
- •Patient has undergone or is scheduled for a coronary artery bypass graft procedure, 30 days before or 30 days after date of potential enrollment
- •Patient has a known life expectancy of less than 6 months due to non cardiac causes
- •Patient has marked renal dysfunction defined as Creatinine > 2.5 mg/dL at time of enrollment
- •Patient enrolled in any concurrent study that may confound the results of the study
- •Patient is in class IV heart failure
- •Patient is on the heart transplant list
- •Patient already has an implanted pacemaker, ICD, or CRT device
- •Patient is pregnant or plans to be pregnant during the course of the study
结局指标
主要结局
LVEDV
时间窗: 12 months
次要结局
- ECG(12 months)
- Device parameters(12 months)
- Quality of Life(12 months)
- Cardiac echo(12 months)
- LVESV(12 months)
- Blood chemistry(12 months)
研究者
研究点 (2)
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