ST Segment Detection Study

Medtronic Cardiac Rhythm and Heart Failure0 sites175 target enrollmentApril 2008

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Enrollment: 175
Primary Endpoint: Number of Participants With ST Segment Changes During Myocardial Infarction
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2008

End Date

March 2011

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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 Outcomes

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)