ST Detect: ST Segment Detection Study

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00930969
• Collaborator: (none)
• Enrollment: 175
• Locations: 25
• Duration (Months): 35
• Patients Per Site: 7
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: ICD

Study Design

• Study Type: Observational
• Actual Enrollment: 175 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: ST Segment Detection Study
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Mar 1, 2011

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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)

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Anchorage	Alaska	United States	99508
2		Brandon	Florida	United States	33511
3		Orlando	Florida	United States	32806
4		Davenport	Iowa	United States	52803
5		Boston	Massachusetts	United States	02215
6		Minneapolis	Minnesota	United States	55407
7		Kansas City	Missouri	United States	64111
8		Mineola	New York	United States	11501
9		Stony Brook	New York	United States	11794
10		Gastonia	North Carolina	United States	28054
11		Raleigh	North Carolina	United States	27610
12		Cincinnati	Ohio	United States	45219
13		Nashville	Tennessee	United States	37203
14		Austin	Texas	United States	78705
15		Burlington	Vermont	United States	05401
16		Richmond	Virginia	United States	23225
17		Morgantown	West Virginia	United States	26505
18		Linz		Austria
19		Liege		Belgium
20		Copenhagen		Denmark
21		Berlin		Germany
22		Heidelberg		Germany
23		Nuremberg		Germany
24		Zwolle		Netherlands
25		Kristiansand		Norway

Sponsors and Collaborators

• Medtronic Cardiac Rhythm and Heart Failure

Investigators

• Principal Investigator: George Crossley, MD, St. Thomas Research Institute and University of Tennessee College of Medicine Nashville, TN
• Principal Investigator: Timothy Henry, MD, Minneapolis Heart Institute Foundation Minneapolis, MN

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT00930969
• Other Study ID Numbers: ST Detect
• First Posted: Jul 2, 2009
• Last Update Posted: Feb 18, 2019
• Last Verified: Jan 1, 2019

• Keywords provided by Medtronic Cardiac Rhythm and Heart Failure: 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)
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease

Study Results

Participant Flow

Arm/Group Title	ICD Indicated
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

Baseline Characteristics

Arm/Group Title	ICD Indicated
Arm/Group Description	Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
Overall Participants	175
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	118 67.4%
>=65 years	57 32.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60 (10)
Sex: Female, Male (Count of Participants)
Female	28 16%
Male	147 84%
Region of Enrollment (participants) [Number]
United States	134 76.6%
Denmark	13 7.4%
Austria	10 5.7%
Norway	3 1.7%
Netherlands	11 6.3%
Germany	3 1.7%
Belgium	1 0.6%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With ST Segment Changes During Myocardial Infarction
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

Outcome Measure Data

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
Arm/Group Description	Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
Measure Participants	0

2. Secondary Outcome

Title	Occurrence of Spontaneous Coronary Event
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

Outcome Measure Data

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
Arm/Group Description	Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
Measure Participants	173
STEMI	0
NSTEMI	2.9
Unstable Angina	5.1

3. Secondary Outcome

Title	ST Segment Changes Measured by an ICD in Subjects Who Test Positive for Ischemia During an Exercise Stress Test
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ICD Indicated
Arm/Group Description	Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
Measure Participants	18
Mean (Standard Deviation) [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.
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

Outcome Measure Data

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
Arm/Group Description	Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
Measure Participants	173
Number [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.
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

Outcome Measure Data

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
Arm/Group Description	Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
Measure Participants	11
Number [Participants]	11 6.3%

Adverse Events

Time Frame	Baseline through 2 years.
Arm/Group Title	ICD Indicated
Arm/Group Description	Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
All Cause Mortality
	ICD Indicated
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	ICD Indicated
	Affected / at Risk (%)	# Events
Total	86/175 (49.1%)
General disorders
Angina pectoris	11/175 (6.3%)	12
Cardiac failure	4/175 (2.3%)	12
Cardiac failure acute	5/175 (2.9%)	11
Pneumonia	5/175 (2.9%)	7
Unstable angina	9/175 (5.1%)	9
Lead dislodgement	5/175 (2.9%)	5
NSTEMI	4/175 (2.3%)	5
Ventricular tachycardia	4/175 (2.3%)	5
Anaemia	4/175 (2.3%)	4
Chest pain	5/175 (2.9%)	5
Dyspnoea	3/175 (1.7%)	4
Chronic obstructive pulmonary disease	3/175 (1.7%)	3
Gastrointestinal haemorrhage	3/175 (1.7%)	3
Inappropriate device therapy	2/175 (1.1%)	3
Urinary tract infection	3/175 (1.7%)	3
Atrial fibrillation	3/175 (1.7%)	3
Atrial flutter	2/175 (1.1%)	2
Bleeding	2/175 (1.1%)	2
Cerebrovascular accident	2/175 (1.1%)	2
Cholecystitis acute	2/175 (1.1%)	2
Deep vein thrombosis	4/175 (2.3%)	4
Gastroenteritis	2/175 (1.1%)	2
Hypotension	2/175 (1.1%)	3
Implant site infection	2/175 (1.1%)	2
Intermittent claudication	2/175 (1.1%)	2
Ischaemic cardiomyopathy	2/175 (1.1%)	2
Non-cardiac chest pain	2/175 (1.1%)	2
Pulmonary embolus	2/175 (1.1%)	2
Seizure	1/175 (0.6%)	2
Syncope	2/175 (1.1%)	2
Acute renal insufficiency	1/175 (0.6%)	1
Atelectasis	1/175 (0.6%)	1
Abdominal hernia	1/175 (0.6%)	1
Abscess	1/175 (0.6%)	1
Acute coronary syndrome	1/175 (0.6%)	1
Adenocarcinoma	1/175 (0.6%)	1
Adverse drug reaction	1/175 (0.6%)	1
Ankle fracture	1/175 (0.6%)	1
Atrial tachycardia	1/175 (0.6%)	1
Bronchitis bacterial	1/175 (0.6%)	1
COPD Exacerbation	1/175 (0.6%)	1
Cardio-respiratory arrest	1/175 (0.6%)	1
Carotid artery stenosis	1/175 (0.6%)	1
Cellulitis	1/175 (0.6%)	1
Clostridium difficile sepsis	1/175 (0.6%)	1
Colitis ischaemic	1/175 (0.6%)	1
Colon cancer	1/175 (0.6%)	1
Dehydration	1/175 (0.6%)	1
Diverticular perforation	1/175 (0.6%)	1
Diverticulum	1/175 (0.6%)	1
Dressler's syndrome	1/175 (0.6%)	1
Endocarditis	1/175 (0.6%)	1
Faecaloma	1/175 (0.6%)	1
Fall	1/175 (0.6%)	1
Fatigue	1/175 (0.6%)	1
Gastritis	1/175 (0.6%)	1
Gout	1/175 (0.6%)	1
Hypotension	1/175 (0.6%)	1
Haematuria	1/175 (0.6%)	1
Haemoptysis	1/175 (0.6%)	1
Hepatitis C	1/175 (0.6%)	1
Hypersensitivity	1/175 (0.6%)	1
Hypertension	1/175 (0.6%)	1
Implant site hematoma	1/175 (0.6%)	1
Incision site hematoma	1/175 (0.6%)	1
Incisional hernia	1/175 (0.6%)	1
Infected hydrocele	1/175 (0.6%)	1
Infected sebaceous cyst	1/175 (0.6%)	1
Lower extremity edema	1/175 (0.6%)	1
Lymph node abscess	1/175 (0.6%)	1
Mental status changes	1/175 (0.6%)	1
Musculoskeletal pain	1/175 (0.6%)	1
Nasal septum deviation	1/175 (0.6%)	1
Neuralgia	1/175 (0.6%)	1
Obesity	1/175 (0.6%)	1
Oedema	1/175 (0.6%)	1
Oedema peripheral	1/175 (0.6%)	1
Oesophageal carcinoma	1/175 (0.6%)	1
Orthostatic hypotension	1/175 (0.6%)	1
Pneumothorax	1/175 (0.6%)	1
Pain	1/175 (0.6%)	1
Pain in extremity	1/175 (0.6%)	1
Pancreatitis	1/175 (0.6%)	1
Phimosis	1/175 (0.6%)	1
Post-traumatic headache	1/175 (0.6%)	1
Presyncope	1/175 (0.6%)	1
Radiculopathy	1/175 (0.6%)	1
Rectal cancer	1/175 (0.6%)	1
Renal artery stenosis	1/175 (0.6%)	1
Renal failure acute	1/175 (0.6%)	1
Renal mass	1/175 (0.6%)	1
Respiratory failure	1/175 (0.6%)	1
Respiratory tract infection	1/175 (0.6%)	1
Sepsis	1/175 (0.6%)	1
Sepsis MRSA	1/175 (0.6%)	1
Septic shock	1/175 (0.6%)	1
Skin laceration	1/175 (0.6%)	1
Spinal osteoarthritis	1/175 (0.6%)	1
Staphylococcal bacteraemia	1/175 (0.6%)	1
Stomach mass	1/175 (0.6%)	1
Thyroglossal cyst	1/175 (0.6%)	1
Traumatic fracture	1/175 (0.6%)	1
Urosepsis	1/175 (0.6%)	1
Ventricular fibrillation	1/175 (0.6%)	1
Wound haemorrhage	1/175 (0.6%)	1
Angina Unstable	1/175 (0.6%)	1
Other (Not Including Serious) Adverse Events
	ICD Indicated
	Affected / at Risk (%)	# Events
Total	20/175 (11.4%)
General disorders
Atrial fibrillation	8/175 (4.6%)	8
Angina pectoris	6/175 (3.4%)	7
Dyspnea	6/175 (3.4%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.