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ST Segment Detection Study (ST Detect)

This study has been terminated.
(Low observed spontaneous coronary event rate among enrolled subjects)
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00930969
First received: June 29, 2009
Last updated: March 27, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Coronary Artery Disease
 Device: ICD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ST Segment Detection Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Number of Participants With ST Segment Changes During Myocardial Infarction [ Time Frame: Implant to 2 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Occurrence of Spontaneous Coronary Event [ Time Frame: Implant to 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 175
Study Start Date: April 2008
Study Completion Date: March 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: ICD
    Subjects implanted with an ICD.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930969

  Show 25 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
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
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00930969     History of Changes
Other Study ID Numbers: ST Detect
Study First Received: June 29, 2009
Results First Received: October 27, 2011
Last Updated: March 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Cardiac Ischemia
ST segment elevated Myocardial Infarction (STEMI)
Non-ST Segment elevated Myocardial Infarction (NSTEMI)
 Implantable Cardioverter Defibrillator (ICD)
Cardiac Electrogram (EGM)
Coronary Artery Disease (CAD)

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013