Trial Outcomes & Findings for ST Segment Detection Study (NCT NCT00930969)
NCT ID: NCT00930969
Last Updated: 2019-02-18
Results Overview
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.
Recruitment status
TERMINATED
Target enrollment
175 participants
Primary outcome timeframe
Implant to 2 years
Results posted on
2019-02-18
Participant Flow
Participant milestones
| Measure |
ICD Indicated
Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
|
|---|---|
|
Overall Study
STARTED
|
175
|
|
Overall Study
COMPLETED
|
137
|
|
Overall Study
NOT COMPLETED
|
38
|
Reasons for withdrawal
| Measure |
ICD Indicated
Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
|
|---|---|
|
Overall Study
Death
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Physician Decision
|
13
|
|
Overall Study
Withdrawal by Subject
|
19
|
Baseline Characteristics
ST Segment Detection Study
Baseline characteristics by cohort
| Measure |
ICD Indicated
n=175 Participants
Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
118 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
57 Participants
n=5 Participants
|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
147 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
134 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Implant to 2 yearsPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Implant to 2 yearsPopulation: 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.
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)
Outcome measures
| Measure |
ICD Indicated
n=173 Participants
Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
|
|---|---|
|
Occurrence of Spontaneous Coronary Event
STEMI
|
0 Events per patient year
Interval 0.0 to 2.1
|
|
Occurrence of Spontaneous Coronary Event
NSTEMI
|
2.9 Events per patient year
Interval 1.2 to 6.9
|
|
Occurrence of Spontaneous Coronary Event
Unstable Angina
|
5.1 Events per patient year
Interval 2.7 to 9.9
|
SECONDARY outcome
Timeframe: One-month follow-up visitPatients 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.
Outcome measures
| Measure |
ICD Indicated
n=18 Participants
Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
|
|---|---|
|
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
|
SECONDARY outcome
Timeframe: Implant to 2 yearsPopulation: 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.
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.
Outcome measures
| Measure |
ICD Indicated
n=173 Participants
Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
|
|---|---|
|
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 outcome
Timeframe: Six-month follow-up visitPopulation: 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.
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.
Outcome measures
| Measure |
ICD Indicated
n=11 Participants
Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
|
|---|---|
|
Participants That Consented to Wear a Holter Monitor for a Period of 24 Hours to Collect Heart Sounds Data.
|
11 Participants
|
Adverse Events
ICD Indicated
Serious events: 86 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ICD Indicated
n=175 participants at risk
Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
|
|---|---|
|
General disorders
Angina pectoris
|
6.3%
11/175 • Number of events 12 • Baseline through 2 years.
|
|
General disorders
Cardiac failure
|
2.3%
4/175 • Number of events 12 • Baseline through 2 years.
|
|
General disorders
Cardiac failure acute
|
2.9%
5/175 • Number of events 11 • Baseline through 2 years.
|
|
General disorders
Pneumonia
|
2.9%
5/175 • Number of events 7 • Baseline through 2 years.
|
|
General disorders
Unstable angina
|
5.1%
9/175 • Number of events 9 • Baseline through 2 years.
|
|
General disorders
Lead dislodgement
|
2.9%
5/175 • Number of events 5 • Baseline through 2 years.
|
|
General disorders
NSTEMI
|
2.3%
4/175 • Number of events 5 • Baseline through 2 years.
|
|
General disorders
Ventricular tachycardia
|
2.3%
4/175 • Number of events 5 • Baseline through 2 years.
|
|
General disorders
Anaemia
|
2.3%
4/175 • Number of events 4 • Baseline through 2 years.
|
|
General disorders
Chest pain
|
2.9%
5/175 • Number of events 5 • Baseline through 2 years.
|
|
General disorders
Dyspnoea
|
1.7%
3/175 • Number of events 4 • Baseline through 2 years.
|
|
General disorders
Chronic obstructive pulmonary disease
|
1.7%
3/175 • Number of events 3 • Baseline through 2 years.
|
|
General disorders
Gastrointestinal haemorrhage
|
1.7%
3/175 • Number of events 3 • Baseline through 2 years.
|
|
General disorders
Inappropriate device therapy
|
1.1%
2/175 • Number of events 3 • Baseline through 2 years.
|
|
General disorders
Urinary tract infection
|
1.7%
3/175 • Number of events 3 • Baseline through 2 years.
|
|
General disorders
Atrial fibrillation
|
1.7%
3/175 • Number of events 3 • Baseline through 2 years.
|
|
General disorders
Atrial flutter
|
1.1%
2/175 • Number of events 2 • Baseline through 2 years.
|
|
General disorders
Bleeding
|
1.1%
2/175 • Number of events 2 • Baseline through 2 years.
|
|
General disorders
Cerebrovascular accident
|
1.1%
2/175 • Number of events 2 • Baseline through 2 years.
|
|
General disorders
Cholecystitis acute
|
1.1%
2/175 • Number of events 2 • Baseline through 2 years.
|
|
General disorders
Deep vein thrombosis
|
2.3%
4/175 • Number of events 4 • Baseline through 2 years.
|
|
General disorders
Gastroenteritis
|
1.1%
2/175 • Number of events 2 • Baseline through 2 years.
|
|
General disorders
Hypotension
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Implant site infection
|
1.1%
2/175 • Number of events 2 • Baseline through 2 years.
|
|
General disorders
Intermittent claudication
|
1.1%
2/175 • Number of events 2 • Baseline through 2 years.
|
|
General disorders
Ischaemic cardiomyopathy
|
1.1%
2/175 • Number of events 2 • Baseline through 2 years.
|
|
General disorders
Non-cardiac chest pain
|
1.1%
2/175 • Number of events 2 • Baseline through 2 years.
|
|
General disorders
Pulmonary embolus
|
1.1%
2/175 • Number of events 2 • Baseline through 2 years.
|
|
General disorders
Seizure
|
0.57%
1/175 • Number of events 2 • Baseline through 2 years.
|
|
General disorders
Syncope
|
1.1%
2/175 • Number of events 2 • Baseline through 2 years.
|
|
General disorders
Acute renal insufficiency
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Atelectasis
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Abdominal hernia
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Abscess
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Acute coronary syndrome
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Adenocarcinoma
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Adverse drug reaction
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Ankle fracture
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Atrial tachycardia
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Bronchitis bacterial
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
COPD Exacerbation
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Cardio-respiratory arrest
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Carotid artery stenosis
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Cellulitis
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Clostridium difficile sepsis
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Colitis ischaemic
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Colon cancer
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Dehydration
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Diverticular perforation
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Diverticulum
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Dressler's syndrome
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Endocarditis
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Faecaloma
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Fall
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Fatigue
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Gastritis
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Gout
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Haematuria
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Haemoptysis
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Hepatitis C
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Hypersensitivity
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Hypertension
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Implant site hematoma
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Incision site hematoma
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Incisional hernia
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Infected hydrocele
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Infected sebaceous cyst
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Lower extremity edema
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Lymph node abscess
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Mental status changes
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Musculoskeletal pain
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Nasal septum deviation
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Neuralgia
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Obesity
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Oedema
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Oedema peripheral
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Oesophageal carcinoma
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Orthostatic hypotension
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Pneumothorax
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Pain
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Pain in extremity
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Pancreatitis
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Phimosis
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Post-traumatic headache
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Presyncope
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Radiculopathy
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Rectal cancer
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Renal artery stenosis
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Renal failure acute
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Renal mass
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Respiratory failure
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Respiratory tract infection
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Sepsis
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Sepsis MRSA
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Septic shock
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Skin laceration
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Spinal osteoarthritis
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Staphylococcal bacteraemia
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Stomach mass
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Thyroglossal cyst
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Traumatic fracture
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Urosepsis
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Ventricular fibrillation
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Wound haemorrhage
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
|
General disorders
Angina Unstable
|
0.57%
1/175 • Number of events 1 • Baseline through 2 years.
|
Other adverse events
| Measure |
ICD Indicated
n=175 participants at risk
Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
|
|---|---|
|
General disorders
Atrial fibrillation
|
4.6%
8/175 • Number of events 8 • Baseline through 2 years.
|
|
General disorders
Angina pectoris
|
3.4%
6/175 • Number of events 7 • Baseline through 2 years.
|
|
General disorders
Dyspnea
|
3.4%
6/175 • Number of events 6 • Baseline through 2 years.
|
Additional Information
ST Detect Study Team
Medtronic Cardiac Rhythm Disease Management
Phone: 1-800-328-2518
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee In most cases, contracts allow investigators ("PI") to publish per the publication strategy/Clinical Investigational Plan following Medtronic's review for (a) disclosure of confidential information ("CI"), and (b) selection and order of publications by the publications committee. Any such CI is deleted prior to publication/presentation. Medtronic may not otherwise censor/interfere with the publication.
- Publication restrictions are in place
Restriction type: OTHER