Coronary Artery Disease
Conditions
Keywords
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)
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.
Interventions
DEVICEICD
Subjects implanted with an ICD.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With ST Segment Changes During Myocardial Infarction | 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
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Spontaneous Coronary Event | 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) |
| ST Segment Changes Measured by an ICD in Subjects Who Test Positive for Ischemia During an Exercise Stress Test | 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. |
| 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 | 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. | 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. |
Countries
Austria, Belgium, Denmark, Germany, Netherlands, Norway, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ICD Indicated Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction. | 175 |
| Total | 175 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 5 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 13 |
| Overall Study | Withdrawal by Subject | 19 |
Baseline characteristics
| Characteristic | ICD Indicated |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 57 Participants |
| Age, Categorical Between 18 and 65 years | 118 Participants |
| Age, Continuous | 60 years STANDARD_DEVIATION 10 |
| Region of Enrollment Austria | 10 participants |
| Region of Enrollment Belgium | 1 participants |
| Region of Enrollment Denmark | 13 participants |
| Region of Enrollment Germany | 3 participants |
| Region of Enrollment Netherlands | 11 participants |
| Region of Enrollment Norway | 3 participants |
| Region of Enrollment United States | 134 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 147 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 175 |
| serious Total, serious adverse events | 86 / 175 |
Outcome results
Primary
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.
Time frame: Implant to 2 years
Population: During the study, none of the subjects presented with a ST Elevation Myocardial Infarction (STEMI). Therefore, there was not the opportunity to measure the hearts electrical activity during one of these events.
Secondary
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.
Time frame: Implant to 2 years
Population: There were 175 subjects that consented to participate in the study, and two subjects were not implanted with an ICD by the time the study was terminated. Therefore the number of years of stored device data to utilize for future research as collected by the implanted ICD in the remaining 173 subjects was analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ICD Indicated | 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. | 164.1 Years |
Secondary
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)
Time frame: Implant to 2 years
Population: There were 175 subjects that consented to participate in the study, and two subjects were not implanted with an ICD by the time the study was terminated. Therefore data collected by the implanted ICD in the remaining 173 subjects was analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ICD Indicated | Occurrence of Spontaneous Coronary Event | STEMI | 0 Events per patient year |
| ICD Indicated | Occurrence of Spontaneous Coronary Event | NSTEMI | 2.9 Events per patient year |
| ICD Indicated | Occurrence of Spontaneous Coronary Event | Unstable Angina | 5.1 Events per patient year |
Secondary
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.
Time frame: Six-month follow-up visit
Population: A subset of participants opting to wear a Holter monitor for 24 hours to collect Heart Sounds data, and then returning the following day for device reprogramming.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ICD Indicated | Participants That Consented to Wear a Holter Monitor for a Period of 24 Hours to Collect Heart Sounds Data. | 11 Participants |
Secondary
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.
Time frame: One-month follow-up visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ICD Indicated | ST Segment Changes Measured by an ICD in Subjects Who Test Positive for Ischemia During an Exercise Stress Test | 1.23 millivolts | Standard Deviation 0.91 |