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ST Segment Detection Study (ST Detect)

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ClinicalTrials.gov Identifier: NCT00930969
Recruitment Status : Terminated (Low observed spontaneous coronary event rate among enrolled subjects)
First Posted : July 2, 2009
Results First Posted : April 20, 2012
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Tracking Information
First Submitted Date June 29, 2009
First Posted Date July 2, 2009
Results First Submitted Date October 27, 2011
Results First Posted Date April 20, 2012
Last Update Posted Date February 18, 2019
Study Start Date April 2008
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 27, 2012)
Number of Participants With ST Segment Changes During Myocardial Infarction [ Time Frame: Implant to 2 years ]
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.
Original Primary Outcome Measures
 (submitted: June 30, 2009)
ST segment changes [ Time Frame: Implant to 2 years ]
Change History Complete list of historical versions of study NCT00930969 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 27, 2012)
  • Occurrence of Spontaneous Coronary Event [ Time Frame: Implant to 2 years ]
    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)
  • ST Segment Changes Measured by an ICD in Subjects Who Test Positive for Ischemia During an Exercise Stress Test [ Time Frame: One-month follow-up visit ]
    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.
  • 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. [ Time Frame: Implant to 2 years ]
    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.
  • Participants That Consented to Wear a Holter Monitor for a Period of 24 Hours to Collect Heart Sounds Data. [ Time Frame: Six-month follow-up visit ]
    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.
Original Secondary Outcome Measures
 (submitted: June 30, 2009)
  • Occurrence of Spontaneous Coronary Event [ Time Frame: Implant to 2 years ]
  • EGM based ST Changes [ Time Frame: Implant to 2 years ]
  • EGM database of ambulatory signals [ Time Frame: Implant to 2 years ]
  • Heart Sounds [ Time Frame: Implant to 2 years ]
  • Adverse Events [ Time Frame: Baseline to 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ST Segment Detection Study
Official Title ST Segment Detection Study
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects coming into the hospital or the emergency room needing a defibrillator device having had coronary artery disease as outlined in the inclusion criteria.
Condition Coronary Artery Disease
Intervention Device: ICD
Subjects implanted with an ICD.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: March 27, 2012)
175
Original Estimated Enrollment
 (submitted: June 30, 2009)
230
Actual Study Completion Date March 2011
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   Belgium,   Denmark,   Germany,   Netherlands,   Norway,   United States
Removed Location Countries South Africa
 
Administrative Information
NCT Number NCT00930969
Other Study ID Numbers ST Detect
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Medtronic Cardiac Rhythm and Heart Failure
Study Sponsor Medtronic Cardiac Rhythm and Heart Failure
Collaborators Not Provided
Investigators
Principal Investigator: George Crossley, MD St. Thomas Research Institute and University of Tennessee College of Medicine Nashville, TN
Principal Investigator: Timothy Henry, MD Minneapolis Heart Institute Foundation Minneapolis, MN
PRS Account Medtronic Cardiac Rhythm and Heart Failure
Verification Date January 2019