BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 802
- 试验地点
- 118
- 主要终点
- Kaplan-Meier Estimate of Percentage of Participants With Major Adverse Cardiac Event (MACE)
研究概览
简要总结
The BIO|GUARD-MI study investigates whether continuous arrhythmia monitoring and the consequent treatment after detected arrhythmias in patients after myocardial infarction with preserved cardiac function, but other risk factors, decreases the risk of major adverse cardiac events.
详细描述
Patients randomized to the BioMonitor arm will receive an implantable cardiac monitor (ICM; BioMonitor) with remote monitoring function (Home Monitoring®). If the device detects and reports an arrhythmia, patients will be appropriately examined and treated. Patients randomized to the control arm will receive best proven treatment, but no implantable cardiac monitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
An independent Endpoint Committee was installed to evaluate all reported cardiovascular and serious AEs. The information provided to the Committee did not contain information about the group assigment of the patients.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has a history of MI according to guidelines
- •CHA2DS2-VASc-Score ≥ 4 in men / ≥ 5 in women
- •LVEF > 35 % as estimated within 6 months before enrollment but after conclusion of AMI treatment
- •Patient accepts activation of Home Monitoring®
- •Patient is able to understand the nature of the clinical study and has provided written informed consent
排除标准
- •Patients with hemorrhagic diathesis
- •Permanent oral anticoagulation treatment for atrial fibrillation
- •Indication for chronic renal dialysis
- •Pacemaker or ICD implanted or indication for implantation
- •Parkinson's disease
- •Life expectancy < 1 year
- •Participation in another interventional clinical Investigation
- •Age < 18 years
- •Woman who are pregnant or breast feeding
结局指标
主要结局
Kaplan-Meier Estimate of Percentage of Participants With Major Adverse Cardiac Event (MACE)
时间窗: 2 years
The primary endpoint is defined as death for cardiovascular reasons or unplanned hospitalization for cardiovascular reasons as per study protocol. The time period with regards to the Time-to-Event Outcome Measures starts with the randomization of the patient. All patients will be assessed for Time-to-Event Outcome Measures until formal study termination is announced or until the individual patient meets a drop out criterion in accordance with the study protocol. The study period is estimated 6 years.
次要结局
- Kaplan-Meier Estimate of Percentage of Participants With Outcome of Death Due to Any Cause(2 years)
- Kaplan-Meier Estimate of Percentage of Participants With Outcome of Cardiovascular Death or Heart Transplantation(2 years)
- Kaplan-Meier Estimate of Percentage of Participants With Acute Coronary Syndrome Resulting in Hospitalization(2 years)
- Type of Initiated Therapies(All data are collected for the period from randomization until official study end or drop-out, for all enrolled patients, up to 6 years.)
- Kaplan-Meier Estimate of Percentage of Participants With an Arrhythmia(2 years)
- Kaplan-Meier Estimate of Percentage of Participants Receiving Therapy After Arrhythmia Diagnosis(2 years)
- Kaplan-Meier Estimate of Percentage of Participants With Outcome of Death Due to Any Cause or Heart Transplantation(2 years)
- Kaplan-Meier Estimate of Percentage of Participants With Worsening of Heart Failure Requiring Hospitalization or Urgent Visit(2 years)
- Kaplan-Meier Estimate of Percentage of Participants With Stroke Resulting in Hospitalization(2 years)
- Kaplan-Meier Estimate of Percentage of Participants With an Arrhythmia Resulting in Hospitalization(2 years)
- Kaplan-Meier Estimate of Percentage of Participants With Major Bleeding Resulting in Hospitalization(2 years)
- Kaplan-Meier Estimate of Percentage of Participants With Systemic Embolism Resulting in Hospitalization(2 years)
- Change in World Health Organization Five Well-being Index (WHO-5) From 6 Months to 24 Months.(We report the intraindividual change from 6-months to 24-months. All data are collected for the period from randomization until official study end or drop-out, for all enrolled patients.)