Home Telemonitoring In Patients After Myocardial Infarction, HELP ME Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 195
- 试验地点
- 2
- 主要终点
- Mortality Rate
研究概览
简要总结
This study is being done to determine if taking an electrocardiogram (ECG) by a portable device (SmartHeart) followed by a phone call will improve patient outcomes by early recognition of abnormalities and decrease emergency room visits and hospital readmissions compared to standard therapy alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute myocardial infarction, both STEMI and non-STEMI.
- •Able to use the home ECG telemonitoring.
- •Must have smartphone device with home wi-fi/mobile internet which allows for 24/7 ability to transmit ECG.
- •Caring family member who will be able to help/perform the ECG in case the patient won't be able to do it.
排除标准
- •No ability to use the device at home/unable to comply with the device instructions
- •No smartphone device or home wi-fi/mobile internet which prevent 24/7 ability to transmit ECG
- •Cannot download the smartheart app
- •No support in home environment
- •Out of hospital cardiac arrest: secondary to a non-shockable rhythm, unrelated to an acute coronary syndrome, or with any level of neurologic damage.
- •Resident of nursing home or acute care facility
- •Uninterpretable ECG at discharge - left bundle branch block (LBBB), pacemaker or implantable cardioverter defibrillator (ICD) with pacing dependence.
- •Patients who are planned for staged PCI after the index hospitalization
结局指标
主要结局
Mortality Rate
时间窗: 90 days after hospital discharge
Number of deaths over a period of 90 days after an index hospitalization for an acute myocardial infarction
Emergency Room Visits
时间窗: 90 days after hospital discharge
Number of emergency room visits over a period of 90 days after an index hospitalization for an acute myocardial infarction
Re-hospitalizations
时间窗: 90 days after hospital discharge
Number of re-hospitalizations over a period of 90 days after an index hospitalization for an acute myocardial infarction
Major Adverse Cardiovascular Events
时间窗: 90 days after hospital discharge
Number of major adverse cardiovascular events including cardiovascular death and hospitalization for myocardial infarction, unstable angina, repeat revascularization, heart failure, stroke, arrhythmias, and cardiac arrest over a period of 90 days after an index hospitalization for an acute myocardial infarction
次要结局
未报告次要终点
研究者
Joerg Herrmann, MD
Principal Investigator
Mayo Clinic