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A Clinical Evaluation of ST Changes in a Group of Patients Having Ventricular Arrhythmias (inSighT)

2019年7月24日 更新者:Abbott Medical Devices
The purpose of this investigation is to determine the prevalence of device-recorded ST segment changes occurring before appropriate Implantable Cardiac Defibrillator (ICD) therapies (ATP or Shock) and to define their temporal relationship to ventricular arrhythmias.

研究概览

地位

完全的

详细说明

Sudden cardiac death due to cardiac arrhythmia is a devastating and unpredictable complication of coronary artery disease.

Implantation of automatic implantable cardioverter defibrillators (ICD) is a well established therapy for the treatment and prevention of sudden cardiac death. Evidence for the use of these devices has been provided by a number of landmark clinical trials over the last 16 years.

Reduction in ischemia can be achieved by coronary artery revascularization but in many patients may occur a gradual progression to recurrence of ischemia resulting in further life threatening arrhythmias. It is reasonable to assume that unchecked progression of ischemic heart disease may result in increased mortality in ICD patients. It has been shown that the long term mortality risk for ICD patients can be linked to the time since the last coronary revascularization procedure. Both MADIT-II and Sudden Cardiac Death in Heart Failure trial (SCD-HeFT) showed that patients receiving inappropriate ICD therapy have an increased risk of death. It has been speculated that this may be due to progression of the disease and recurrent ischemia.

A feature available in some ICDs manufactured by St Jude medical enables the constant beat to beat monitoring of the intra-cardiac ST segment using the implanted ICD leads. Similar systems have demonstrated this approach to be a reliable method of identifying ischemic events. However, the predictive value of the ST monitoring feature in identifying pending arrhythmic events has yet to be established. Prediction of worsening ischemia could play an important part in allowing physicians to identify ICD patients with greater mortality risk and allow them the time to personalize patient therapy in order to reduce that risk.

研究类型

观察性的

注册 (实际的)

481

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Bad Nauheim、德国、D-61231
        • Kerckhoff Klinik

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patient is implanted with SJM ICD and has or is at high risk of CAD

描述

Inclusion Criteria:

  • The patient is implanted with an St Jude Medical (SJM) ICD with ST Monitoring and ShockGuard™ features (and remote care feature in case Merlin.net will be used)
  • The patient, in the opinion of the investigator, will not require ventricular pacing for more than 20% of the time.
  • The patient, in the opinion of the investigator, has or is at high risk of Coronary Artery Disease (CAD).
  • The patient is ≥ 18 years of age.
  • The patient is able to provide written Informed Consent prior to any investigational related procedure.

Exclusion Criteria:

  • The patient has longstanding persistent Atrial Fibrillation (AF) /Atrial Flutter (AFl) or permanent AF/AFl
  • The patient has documented complete heart block.
  • The patient is known to have uncontrolled ventricular bigeminy or trigeminy (PVCs on regular basis).
  • The patient has severe Left Ventricular Hypertrophy resulting in interventricular conduction defect (IVCD).
  • The patient has intermittent bundle branch blocks (BBB).
  • The patient is unable to comply with the follow up schedule.
  • The patient is participating in another investigational device or drug investigation.
  • The patient is pregnant or is planning to become pregnant during the duration of the investigation.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Among Patients With an Appropriate ICD Therapy (Shock or ATP) for Ventricular Tachycardia or Fibrillation, the Number of Patients Who Have Characterized ST Segment Changes From Baseline Prior to the Therapy Was Calculated.
大体时间:Until the end of follow up period
Until the end of follow up period

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Johannes SPERZEL, MD、Kerckhoff Klinik, Bad Nauheim Germany

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年12月1日

初级完成 (实际的)

2016年1月1日

研究完成 (实际的)

2016年4月1日

研究注册日期

首次提交

2012年9月11日

首先提交符合 QC 标准的

2012年9月11日

首次发布 (估计)

2012年9月13日

研究记录更新

最后更新发布 (实际的)

2019年8月28日

上次提交的符合 QC 标准的更新

2019年7月24日

最后验证

2019年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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