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临床试验/NCT00284453
NCT00284453已完成不适用

Gene Expression in ICD Patients With Electrical Storm

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2008年8月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
2
主要终点
Genetic Testing

研究概览

简要总结

The purpose of the proposed pilot study is to identify factors which are associated with periods of high ventricular arrhythmia burden. This will be performed by analysis of gene expression from peripheral blood samples.

详细描述

This is a study of patients with ICD implants who present with multiple(>2), low-level(1-2) or inappropriate therapies to their defibrillator. The purpose of this pilot study is to identify factors which are associated with periods of high ventricular arrhythmia burden by looking at gene expression from peripheral blood, in addition to levels of known markers of CHF, including catecholamine levels, B-type natriuretic peptide, and troponin. This study hypothesizes that extrinsic or systemic factors play a role in triggering these events, and if true should yield candidate proteins which would spawn functional studies to prove a role in causation. Additionally, identification of a marker of increased recurrence of events may aid in guiding therapy (starting an anti-arrhythmic versus awaiting the next event).

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

入选标准

  • ICD patients at least 18 years of age that present within a 72 hour period: 1) > 2 therapies for ventricular arrhythmias; 2) 1-2 therapies for ventricular arrhythmias; 3) inappropriate therapies for ventricular arrhythmias
  • Able to give informed consent

排除标准

  • Inability to give informed consent

结局指标

主要结局

Genetic Testing

时间窗: Day 90 +/- 30 days

Identification of factors which are associated with periods of high ventricular arrhythmia burden (Day 1) by looking at gene expression from peripheral blood, in addition to levels of known markers of congestive heart failure (catecholamine levels, B-type natriuretic peptide, and troponin)in comparison to subject's return to own normal state (3 month +/- 30 days)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sandeep Jain

MD, Assistant Professor, UPMC Heart and Vascular Institute, Cardiac Electrophysiology

University of Pittsburgh

研究点 (2)

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