ACTRN12614000042640招募中未知
PROTECT-ICD Trial: A study targeting prevention of sudden cardiac death in patients who have reduced cardiac function following a myocardial infarct by assessing whether electrophysiologic study to guide prophylactic implantation of an implantable cardioverter-defibrillator (ICD) early following myocardial infarction (first 40 days) will lead to a significant reduction in sudden cardiac death.
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 1,058
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 85 Years(—)
- 性别
- All
入选标准
- •Participants will be 2-40 days (inclusive) following a myocardial infarct, with impaired left ventricular systolic function (Left Ventricular Ejection Fraction <=40% or at least moderately impaired).
排除标准
- •* Pregnancy;
- •* Nursing home resident dependent on one or more activities of daily living;
- •* Significant non-cardiac co-morbidity with high likelihood of death within 1 year;
- •* Significant psychiatric illnesses that may be aggravated by device implantation or that may preclude regular follow up;
- •* Intravenous drug abuse (ongoing);
- •* Unresolved infection associated with risk for hematogenous seeding;
- •* Pre-existing implantable cardioverter-defibrillator (ICD);
- •* Secondary prevention indication for an ICD (i.e. sustained ventricular arrhythmias occurring more than 48 hours after qualifying myocardial infarction);
- •* On the heart transplant list;
- •* Recurrent unstable angina despite revascularisation (defined as ongoing chest pain or ischemic symptoms at rest or with minimal exertion despite adequate treatment with anti-anginal medications);
- •* Congestive heart failure New York Heart Association class IV, defined as shortness of breath at rest, which is refractory to medical treatment (not responding to treatment)
研究者
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