NCT00673842已完成3 期
Risk Estimation Following Infarction Noninvasive Evaluation - ICD Efficacy
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 700
- 试验地点
- 79
- 主要终点
- Mortality
研究概览
简要总结
This study will assess whether an implantable defibrillator will increase the likelihood of survival in patients who have had a heart attack, have abnormal test results from a 24 hour heart monitor, and who have low normal heart function.
详细描述
The REFINE ICD trial will assess whether prophylactic ICD therapy, guided by non-invasive risk assessment tools, reduces mortality in MI survivors with better-preserved LV function.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Site investigators are responsible for screening. Subjects must meet all inclusion criteria. Subjects with any
排除标准
- •will be excluded.
- •Initial inclusion criteria (eligibility for Holter screening).
- •18 - 80 years old at time of consent
- •History of MI ≥ 2 months prior to screening based on ESC/ACCF/AHA/WHF criteria (both STEMI and NSTEMI subjects are eligible)
- •Appropriate post-MI management including revascularization where indicated
- •No contra-indication for transvenous ICD placement (e.g., mechanical tricuspid valve, known vascular access problems, active sepsis, etc.)
- •LVEF 36% - 50% measured at least 40 days after a confirmed MI ≥ 3 months after coronary angioplasty or coronary bypass surgery and within the following time windows:
- •LVEF ≤ 7 months of screening visit if index MI was ≤ 1 year of enrolment
- •LVEF ≤ 13 months of screening visit if index MI was > 1 & < 3 years of enrolment
- •LVEF ≤ 25 months of screening visit if index MI was ≥ 3 years of enrolment
- •Proven, necessary or appropriate medications (e.g. beta-blocker, ACE inhibitor / ARB, statin, and anti-platelet)
- •In normal sinus rhythm (ECG documented) ≤ 8 weeks prior to the screening Holter
- •Written informed consent
- •Able and willing to complete the screening Holter, including the six-minute hall walk
- •Additional inclusion criterion (eligibility for randomization).
- •Abnormal HRT & TWA (core lab interpretation) on Holter performed at least 2 months after the index MI and the specified time after coronary revascularization
- •In normal sinus rhythm (ECG documented) within 8 weeks prior to the screening Holter
- •In normal sinus rhythm for ≥ 18 hours of the 24 hr screening Holter as determined by the study Holter Core Lab
- •Exclusion criteria (randomization or registry).
- •Use of antiarrhythmic drugs
- •Clinical indication for permanent pacemaker or a cardiac resynchronization device
- •Clinical indication for an ICD or cardiac resynchronization ICD
- •Prior implantation of a pacemaker, ICD, or Cardiac Resynchronization device
- •Any condition, in the investigator's judgment, that would limit life expectancy to < 12 months
- •Chronic renal failure (hemodialysis or peritoneal dialysis)
- •Active ischemia that is amenable to revascularization if not previously revascularized
- •Participation in another trial that may interfere with the REFINE ICD results.
- •Pregnancy
- •Inability to comply with the follow-up schedule
研究组 & 干预措施
ICD + Usual Care
Experimental
Implantable Cardioverter Defibrillator + Usual Care
干预措施: Implantable Cardioverter Defibrillator + Usual Care (Device)
Usual Care
Active Comparator
Usual post-MI care
干预措施: Usual care (Other)
结局指标
主要结局
Mortality
时间窗: Minimum of 18 months of follow-up (average follow-up of 5 years).
次要结局
- Appropriate ICD therapies(Average follow-up 5 years.)
- Arrhythmic syncope(Average follow-up 5 years.)
- Quality of life(Average follow-up 5 years.)
- Cardiac death(Average follow-up 5 years.)
- Arrhythmic death(Average follow-up 5 years.)
- Inappropriate ICD therapies(Five years (average))
研究者
Dr. Derek Exner
Professor and Canada Research Chair in Cardiovascular Clinical Trials
University of Calgary
研究点 (79)
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