ST Segment Detection Study

Study Overview
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Brief Summary
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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.

Official Title
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ST Segment Detection Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: ICD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ICD|Subjects implanted with an ICD.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Spontaneous Coronary Event | 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) | Implant to 2 years | 
| ST Segment Changes Measured by an ICD in Subjects Who Test Positive for Ischemia During an Exercise Stress Test | 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. | 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. | 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. | Implant to 2 years | 
| Participants That Consented to Wear a Holter Monitor for a Period of 24 Hours to Collect Heart Sounds Data. | 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. | Six-month follow-up visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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)