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ST Segment Detection Study (ST Detect)

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ClinicalTrials.gov Identifier: NCT00930969
Recruitment Status : Terminated (Low observed spontaneous coronary event rate among enrolled subjects)
First Posted : July 2, 2009
Results First Posted : April 20, 2012
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Coronary Artery Disease
Intervention Device: ICD
Enrollment 175
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ICD Indicated
Hide Arm/Group Description Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
Period Title: Overall Study
Started 175
Completed 137
Not Completed 38
Reason Not Completed
Death             5
Lost to Follow-up             1
Physician Decision             13
Withdrawal by Subject             19
Arm/Group Title ICD Indicated
Hide Arm/Group Description Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
Overall Number of Baseline Participants 175
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants
<=18 years
0
   0.0%
Between 18 and 65 years
118
  67.4%
>=65 years
57
  32.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 175 participants
60  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants
Female
28
  16.0%
Male
147
  84.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 175 participants
United States 134
Denmark 13
Austria 10
Norway 3
Netherlands 11
Germany 3
Belgium 1
1.Primary Outcome
Title Number of Participants With ST Segment Changes During Myocardial Infarction
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ICD Indicated
Hide Arm/Group Description:
Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Occurrence of Spontaneous Coronary Event
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title ICD Indicated
Hide Arm/Group Description:
Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
Overall Number of Participants Analyzed 173
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Events per patient year
STEMI
0
(0 to 2.1)
NSTEMI
2.9
(1.2 to 6.9)
Unstable Angina
5.1
(2.7 to 9.9)
3.Secondary Outcome
Title ST Segment Changes Measured by an ICD in Subjects Who Test Positive for Ischemia During an Exercise Stress Test
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ICD Indicated
Hide Arm/Group Description:
Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: millivolts
1.23  (0.91)
4.Secondary Outcome
Title 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.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title ICD Indicated
Hide Arm/Group Description:
Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
Overall Number of Participants Analyzed 173
Measure Type: Number
Unit of Measure: Years
164.1
5.Secondary Outcome
Title Participants That Consented to Wear a Holter Monitor for a Period of 24 Hours to Collect Heart Sounds Data.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title ICD Indicated
Hide Arm/Group Description:
Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: Participants
11
Time Frame Baseline through 2 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ICD Indicated
Hide Arm/Group Description Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
All-Cause Mortality
ICD Indicated
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ICD Indicated
Affected / at Risk (%) # Events
Total   86/175 (49.14%)    
General disorders   
Angina pectoris  11/175 (6.29%)  12
Cardiac failure  4/175 (2.29%)  12
Cardiac failure acute  5/175 (2.86%)  11
Pneumonia  5/175 (2.86%)  7
Unstable angina  9/175 (5.14%)  9
Lead dislodgement  5/175 (2.86%)  5
NSTEMI  4/175 (2.29%)  5
Ventricular tachycardia  4/175 (2.29%)  5
Anaemia  4/175 (2.29%)  4
Chest pain  5/175 (2.86%)  5
Dyspnoea  3/175 (1.71%)  4
Chronic obstructive pulmonary disease  3/175 (1.71%)  3
Gastrointestinal haemorrhage  3/175 (1.71%)  3
Inappropriate device therapy  2/175 (1.14%)  3
Urinary tract infection  3/175 (1.71%)  3
Atrial fibrillation  3/175 (1.71%)  3
Atrial flutter  2/175 (1.14%)  2
Bleeding  2/175 (1.14%)  2
Cerebrovascular accident  2/175 (1.14%)  2
Cholecystitis acute  2/175 (1.14%)  2
Deep vein thrombosis  4/175 (2.29%)  4
Gastroenteritis  2/175 (1.14%)  2
Hypotension  2/175 (1.14%)  3
Implant site infection  2/175 (1.14%)  2
Intermittent claudication  2/175 (1.14%)  2
Ischaemic cardiomyopathy  2/175 (1.14%)  2
Non-cardiac chest pain  2/175 (1.14%)  2
Pulmonary embolus  2/175 (1.14%)  2
Seizure  1/175 (0.57%)  2
Syncope  2/175 (1.14%)  2
Acute renal insufficiency  1/175 (0.57%)  1
Atelectasis  1/175 (0.57%)  1
Abdominal hernia  1/175 (0.57%)  1
Abscess  1/175 (0.57%)  1
Acute coronary syndrome  1/175 (0.57%)  1
Adenocarcinoma  1/175 (0.57%)  1
Adverse drug reaction  1/175 (0.57%)  1
Ankle fracture  1/175 (0.57%)  1
Atrial tachycardia  1/175 (0.57%)  1
Bronchitis bacterial  1/175 (0.57%)  1
COPD Exacerbation  1/175 (0.57%)  1
Cardio-respiratory arrest  1/175 (0.57%)  1
Carotid artery stenosis  1/175 (0.57%)  1
Cellulitis  1/175 (0.57%)  1
Clostridium difficile sepsis  1/175 (0.57%)  1
Colitis ischaemic  1/175 (0.57%)  1
Colon cancer  1/175 (0.57%)  1
Dehydration  1/175 (0.57%)  1
Diverticular perforation  1/175 (0.57%)  1
Diverticulum  1/175 (0.57%)  1
Dressler's syndrome  1/175 (0.57%)  1
Endocarditis  1/175 (0.57%)  1
Faecaloma  1/175 (0.57%)  1
Fall  1/175 (0.57%)  1
Fatigue  1/175 (0.57%)  1
Gastritis  1/175 (0.57%)  1
Gout  1/175 (0.57%)  1
Hypotension  1/175 (0.57%)  1
Haematuria  1/175 (0.57%)  1
Haemoptysis  1/175 (0.57%)  1
Hepatitis C  1/175 (0.57%)  1
Hypersensitivity  1/175 (0.57%)  1
Hypertension  1/175 (0.57%)  1
Implant site hematoma  1/175 (0.57%)  1
Incision site hematoma  1/175 (0.57%)  1
Incisional hernia  1/175 (0.57%)  1
Infected hydrocele  1/175 (0.57%)  1
Infected sebaceous cyst  1/175 (0.57%)  1
Lower extremity edema  1/175 (0.57%)  1
Lymph node abscess  1/175 (0.57%)  1
Mental status changes  1/175 (0.57%)  1
Musculoskeletal pain  1/175 (0.57%)  1
Nasal septum deviation  1/175 (0.57%)  1
Neuralgia  1/175 (0.57%)  1
Obesity  1/175 (0.57%)  1
Oedema  1/175 (0.57%)  1
Oedema peripheral  1/175 (0.57%)  1
Oesophageal carcinoma  1/175 (0.57%)  1
Orthostatic hypotension  1/175 (0.57%)  1
Pneumothorax  1/175 (0.57%)  1
Pain  1/175 (0.57%)  1
Pain in extremity  1/175 (0.57%)  1
Pancreatitis  1/175 (0.57%)  1
Phimosis  1/175 (0.57%)  1
Post-traumatic headache  1/175 (0.57%)  1
Presyncope  1/175 (0.57%)  1
Radiculopathy  1/175 (0.57%)  1
Rectal cancer  1/175 (0.57%)  1
Renal artery stenosis  1/175 (0.57%)  1
Renal failure acute  1/175 (0.57%)  1
Renal mass  1/175 (0.57%)  1
Respiratory failure  1/175 (0.57%)  1
Respiratory tract infection  1/175 (0.57%)  1
Sepsis  1/175 (0.57%)  1
Sepsis MRSA  1/175 (0.57%)  1
Septic shock  1/175 (0.57%)  1
Skin laceration  1/175 (0.57%)  1
Spinal osteoarthritis  1/175 (0.57%)  1
Staphylococcal bacteraemia  1/175 (0.57%)  1
Stomach mass  1/175 (0.57%)  1
Thyroglossal cyst  1/175 (0.57%)  1
Traumatic fracture  1/175 (0.57%)  1
Urosepsis  1/175 (0.57%)  1
Ventricular fibrillation  1/175 (0.57%)  1
Wound haemorrhage  1/175 (0.57%)  1
Angina Unstable  1/175 (0.57%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
ICD Indicated
Affected / at Risk (%) # Events
Total   20/175 (11.43%)    
General disorders   
Atrial fibrillation  8/175 (4.57%)  8
Angina pectoris  6/175 (3.43%)  7
Dyspnea  6/175 (3.43%)  6
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: ST Detect Study Team
Organization: Medtronic Cardiac Rhythm Disease Management
Phone: 1-800-328-2518
EMail: medtronicCRMtrials@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT00930969     History of Changes
Other Study ID Numbers: ST Detect
First Submitted: June 29, 2009
First Posted: July 2, 2009
Results First Submitted: October 27, 2011
Results First Posted: April 20, 2012
Last Update Posted: February 18, 2019