ST Segment Detection Study (ST Detect)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||ST Segment Detection Study|
- 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.
- 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.
|Study Start Date:||April 2008|
|Study Completion Date:||March 2011|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Show 25 Study Locations
|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|