ST Segment Detection Study (ST Detect)
2019年1月30日 更新者：Medtronic Cardiac Rhythm and Heart Failure
The purpose of ST Detect study is to evaluate whether naturally occurring spontaneous coronary events and exercise induced cardiac ischemia, give rise to detectable changes on intracardiac electrogram (EGM) signals in patients that are indicated for an Implantable Cardioverter Defibrillator (ICD) who have coronary artery disease.
研究概览
研究类型
观察性的
注册 (实际的)
175
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
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Copenhagen、丹麦
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Linz、奥地利
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Berlin、德国
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Heidelberg、德国
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Nuremberg、德国
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Kristiansand、挪威
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Liege、比利时
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Alaska
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Anchorage、Alaska、美国、99508
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Florida
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Brandon、Florida、美国、33511
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Orlando、Florida、美国、32806
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Iowa
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Davenport、Iowa、美国、52803
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Massachusetts
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Boston、Massachusetts、美国、02215
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Minnesota
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Minneapolis、Minnesota、美国、55407
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Missouri
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Kansas City、Missouri、美国、64111
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New York
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Mineola、New York、美国、11501
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Stony Brook、New York、美国、11794
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North Carolina
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Gastonia、North Carolina、美国、28054
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Raleigh、North Carolina、美国、27610
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Ohio
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Cincinnati、Ohio、美国、45219
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Tennessee
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Nashville、Tennessee、美国、37203
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Texas
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Austin、Texas、美国、78705
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Vermont
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Burlington、Vermont、美国、05401
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Virginia
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Richmond、Virginia、美国、23225
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West Virginia
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Morgantown、West Virginia、美国、26505
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Zwolle、荷兰
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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
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Subjects coming into the hospital or the emergency room needing a defibrillator device having had coronary artery disease as outlined in the inclusion criteria.
描述
Inclusion Criteria:
- Subject is indicated for an ICD implantation
AND subject must meet ONE of the following:
- Prior acute coronary event
- Previously underwent Percutaneous Coronary Intervention (PCI) or stent procedure
- Multivessel disease
- Positive stress test completed with evidence of ischemic heart disease, as determined by physician, and no subsequent successful revascularization
Exclusion Criteria:
- Subject is currently dependent on ventricular pacing
- Subject has Left Bundle Brunch Block (LBBB) and/or wide QRS
- Subject has chronic Atrial Fibrillation (AF)
- Subject has dementia
- Subject is indicated for a single chamber device
- Subject requires a right sided or abdominal ICD implant
- Subject is pregnant or in fertile age without secure birth control
- Subject has New York Heart Association (NYHA) class IV or refractory heart failure
- Subject is not expected to survive greater than 12 months
- Subject is participating in other confounding research studies
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 |
措施说明 |
大体时间 |
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Number of Participants With ST Segment Changes During Myocardial Infarction
大体时间：Implant to 2 years
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The primary objective of the study was to observe if there are any detectable ST segment changes on an electrogram (EGM) signal from an implanted cardiac defibrillator (ICD) during myocardial infarctions among study participants.
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Implant to 2 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Occurrence of Spontaneous Coronary Event
大体时间：Implant to 2 years
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During the study, spontaneous coronary ischemic events were categorized as STEMI, Non-ST elevated myocardial infarction (NSTEMI), or Unstable Angina.
This objective was to provide estimates of rates per patient year for the study population.
Rates are presented as: Average number of events per patient year (95% Confidence Interval)
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Implant to 2 years
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ST Segment Changes Measured by an ICD in Subjects Who Test Positive for Ischemia During an Exercise Stress Test
大体时间：One-month follow-up visit
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Patients underwent an exercise stress test at their one month study visit.
This objective was to summarize the magnitude of the hearts electrical activity signal measured by the implanted ICD during a positive exercise stress test for ischemia.
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One-month follow-up visit
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Number of Years of Stored Data in a Database of the Hearts Electrical Activity in This Specific Patient Population to be Used for Future Research.
大体时间：Implant to 2 years
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The device in this study included an additional capacity to collect and store information about the hearts electrical activity specific to ischemic heart disease.
This additional capacity of the device is not currently available in market release ICDs.
There is no measure to this objective, other than reporting the number of follow-up years of data accrued, which can be used by Medtronic for additional research.
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Implant to 2 years
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Participants That Consented to Wear a Holter Monitor for a Period of 24 Hours to Collect Heart Sounds Data.
大体时间：Six-month follow-up visit
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When study subjects completed their six-month follow-up visit, they were asked if they would consent to wear a Holter monitor for a period of 24 hours to collect Heart Sounds data.
The study subject would have to return to the center the following day to return the Holter monitor and have their ICD EGM vectors reprogrammed.
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Six-month follow-up visit
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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：George Crossley, MD、St. Thomas Research Institute and University of Tennessee College of Medicine Nashville, TN
- 首席研究员：Timothy Henry, MD、Minneapolis Heart Institute Foundation Minneapolis, MN
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
2008年4月1日
初级完成 (实际的)
2010年11月1日
研究完成 (实际的)
2011年3月1日
研究注册日期
首次提交
2009年6月29日
首先提交符合 QC 标准的
2009年6月30日
首次发布 (估计)
2009年7月2日
研究记录更新
最后更新发布 (实际的)
2019年2月18日
上次提交的符合 QC 标准的更新
2019年1月30日
最后验证
2019年1月1日
更多信息
与本研究相关的术语
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.