Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

ST Segment Detection Study (ST Detect)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment
Coronary Artery Disease Device: ICD

Layout table for study information
Study Type : Observational
Actual Enrollment : 175 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ST Segment Detection Study
Study Start Date : April 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: ICD
    Subjects implanted with an ICD.


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00930969


  Hide Study Locations
Locations
Layout table for location information
United States, Alaska
Anchorage, Alaska, United States, 99508
United States, Florida
Brandon, Florida, United States, 33511
Orlando, Florida, United States, 32806
United States, Iowa
Davenport, Iowa, United States, 52803
United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, Minnesota
Minneapolis, Minnesota, United States, 55407
United States, Missouri
Kansas City, Missouri, United States, 64111
United States, New York
Mineola, New York, United States, 11501
Stony Brook, New York, United States, 11794
United States, North Carolina
Gastonia, North Carolina, United States, 28054
Raleigh, North Carolina, United States, 27610
United States, Ohio
Cincinnati, Ohio, United States, 45219
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Austin, Texas, United States, 78705
United States, Vermont
Burlington, Vermont, United States, 05401
United States, Virginia
Richmond, Virginia, United States, 23225
United States, West Virginia
Morgantown, West Virginia, United States, 26505
Austria
Linz, Austria
Belgium
Liege, Belgium
Denmark
Copenhagen, Denmark
Germany
Berlin, Germany
Heidelberg, Germany
Nuremberg, Germany
Netherlands
Zwolle, Netherlands
Norway
Kristiansand, Norway
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT00930969     History of Changes
Other Study ID Numbers: ST Detect
First Posted: July 2, 2009    Key Record Dates
Results First Posted: April 20, 2012
Last Update Posted: February 18, 2019
Last Verified: January 2019
Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
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:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases