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临床试验/NCT00181233
NCT00181233招募中不适用

Functional Energetics and Imaging for Phenotypic Characterization of Patients at Risk for Sudden Cardiac Death

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2003年10月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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