Recovery of Hibernating Myocardium in End Stage Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Recovery of Myocardial Function
研究概览
简要总结
This study will collect clinical, echocardiographic, nuclear imaging and hemodynamic data in a group of patients with end stage ischemic cardiomyopathy undergoing left ventricular assist device (LVAD) implantation to investigate the incidence of recovery of myocardial function when supported with LVADs, and to study the association between hibernating myocardium and myocardial recovery in this population.
详细描述
Clinical, echocardiographic and hemodynamic data will be obtained from the patients' medical records. Assessment of viability will be performed using a Tl-201 Rest-Redistribution Scintigraphy protocol within 2 weeks before LVAD implantation and 2 months after LVAD implant. Recovery of myocardial function will be assessed using available 2D transthoracic echocardiographic images and with the novel imaging modality, Speckle Tracking Echocardiography (STE), in order to provide a regional quantification of the myocardium, in the context of TL-201 results. Transthoracic echocardiograms will be performed 2 weeks prior to the LVAD implant and 1, 2, 3, 4, 6, 9, and 12 months after implantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or non-pregnant female >= 18 years of age.
- •End stage chronic and dilated ischemic cardiomyopathy requiring LVAD support.
- •Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
- •Ischemic cardiomyopathy is defined by a LVEF < 40% and any of the following:
- •History of myocardial infarction or revascularization.
- •History of angina or chest pain and evidence of scarring in non-invasive imaging studies corresponding to previous myocardial infarction.
- •Presence of ≥ 75% stenosis of the left main or proximal left anterior descending artery, or ≥ 75% stenosis of 2 or more epicardial vessels in a patient with unexplained cardiomyopathy.
排除标准
- •Pregnant and/or lactating women and women of child bearing potential who are not using acceptable means of contraception. Women of childbearing potential must be using adequate measures of contraception (as determined by the Investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period. Women of childbearing potential must have a negative pregnancy test at screen.
- •Patients with acute forms of HF: acute onset of symptoms < 3 months, no left and right ventricular dilation.
- •Other conditions that in the opinion of the Principal Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.
结局指标
主要结局
Recovery of Myocardial Function
时间窗: 2 weeks prior to LVAD implant and 1, 2, 3, 4, 6, 9 and 12 months post LVAD implant
Recovery of myocardial function assessed continuously, using echocardiographic variables (LVEF, circumferential strain and strain rate, segmental strain and strain rate).
次要结局
- Change in the Proportion of Viable, Hibernating Myocardium and Scar after LVAD Implant(2 weeks prior to LVAD implant and 2 months post LVAD implant)