Functional Energetics and Imaging for Phenotypic Characterization of Patients at Risk for Sudden Cardiac Death
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- sudden cardiac death
研究概览
简要总结
Sudden cardiac death is a tragic event that strikes all age groups and is unfortunately increasing in prevalence. Because it is difficult to predict those at highest risk, this study is designed to test the hypothesis that new imaging techniques (magnetic resonance imaging [MRI] and computed tomography [CT]) are useful for identifying factors which put people at high risk for sudden death.
详细描述
Some people with heart disease and a weak heart muscle experience abnormal electrical activity of the heart that may predispose them to sudden death. In light of this risk, it has been recommended that such patients undergo implantation of an implantable cardioverter defibrillator (ICD). Your doctors have determined that you are such a patient and are to undergo implantation of an ICD. It is unclear who among the many patients who undergo ICD implantation for this reason are at greatest risk of sudden death and therefore require electrical response from their ICD. This research is being done to determine whether new imaging tests, such as magnetic resonance imaging (MRI) or multi-detector computed tomography (MDCT), can be used to predict who is at highest risk of sudden death and require electrical response from their ICD.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Left ventricular ejection fraction <or = 35%
- •Planned implantable cardioverter-defibrillator (ICD) implantation for clinical indications (primary prevention)
排除标准
- •History of sudden death (secondary prevention)
- •Contraindication to undergoing MRI (metallic implant, pacemaker, etc.)
结局指标
主要结局
sudden cardiac death
时间窗: 6 month intervals
cardiovascular death
时间窗: 6 month intervals
appropriate ICD discharge
时间窗: 6 month intervals
composite sudden cardiac death and appropriate ICD discharge
时间窗: 6 month intervals
次要结局
- heart failure admission(6 month intervals)
