Study Stopped
Low observed spontaneous coronary event rate among enrolled subjects
ST Segment Detection Study
ST Detect
1 other identifier
observational
175
7 countries
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2008
Typical duration for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 29, 2009
CompletedFirst Posted
Study publicly available on registry
July 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
April 20, 2012
CompletedFebruary 18, 2019
January 1, 2019
2.6 years
June 29, 2009
October 27, 2011
January 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With ST Segment Changes During Myocardial Infarction
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.
Implant to 2 years
Secondary Outcomes (4)
Occurrence of Spontaneous Coronary Event
Implant to 2 years
ST Segment Changes Measured by an ICD in Subjects Who Test Positive for Ischemia During an Exercise Stress Test
One-month follow-up visit
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.
Implant to 2 years
Participants That Consented to Wear a Holter Monitor for a Period of 24 Hours to Collect Heart Sounds Data.
Six-month follow-up visit
Interventions
Subjects implanted with an ICD.
Eligibility Criteria
Subjects coming into the hospital or the emergency room needing a defibrillator device having had coronary artery disease as outlined in the inclusion criteria.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Unknown Facility
Anchorage, Alaska, 99508, United States
Unknown Facility
Brandon, Florida, 33511, United States
Unknown Facility
Orlando, Florida, 32806, United States
Unknown Facility
Davenport, Iowa, 52803, United States
Unknown Facility
Boston, Massachusetts, 02215, United States
Unknown Facility
Minneapolis, Minnesota, 55407, United States
Unknown Facility
Kansas City, Missouri, 64111, United States
Unknown Facility
Mineola, New York, 11501, United States
Unknown Facility
Stony Brook, New York, 11794, United States
Unknown Facility
Gastonia, North Carolina, 28054, United States
Unknown Facility
Raleigh, North Carolina, 27610, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
Unknown Facility
Austin, Texas, 78705, United States
Unknown Facility
Burlington, Vermont, 05401, United States
Unknown Facility
Richmond, Virginia, 23225, United States
Unknown Facility
Morgantown, West Virginia, 26505, United States
Unknown Facility
Linz, Austria
Unknown Facility
Liège, Belgium
Unknown Facility
Copenhagen, Denmark
Unknown Facility
Berlin, Germany
Unknown Facility
Heidelberg, Germany
Unknown Facility
Nuremberg, Germany
Unknown Facility
Zwolle, Netherlands
Unknown Facility
Kristiansand, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- ST Detect Study Team
- Organization
- Medtronic Cardiac Rhythm Disease Management
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2009
First Posted
July 2, 2009
Study Start
April 1, 2008
Primary Completion
November 1, 2010
Study Completion
March 1, 2011
Last Updated
February 18, 2019
Results First Posted
April 20, 2012
Record last verified: 2019-01