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临床试验/ACTRN12614000042640
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.

Western Sydney Local Health District0 个研究点目标入组 1,058 人开始时间: 2014年1月16日最近更新:
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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