Coronary Artery DiseaseST DetectNCT00930969

ST Segment Detection Study

An observational study of Coronary Artery Disease, run by Medtronic Cardiac Rhythm and Heart Failure at 25 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease
What is being tested?: ICD
Type of treatment: Medical device
How many people: 175 participants
Where: 25 sitesin 7 countries
Study dates: Apr 2008to Mar 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Subjects coming into the hospital or the emergency room needing a defibrillator device having had coronary artery disease as outlined in the inclusion criteria.

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

25 sites in 7 countries.

Country

City, postcode or hospital

25 sites in 7 countries

United States17 sites

Study site
Anchorage, Alaska, 99508
Study site
Austin, Texas, 78705
Study site
Boston, Massachusetts, 02215
Study site
Brandon, Florida, 33511
Study site
Burlington, Vermont, 05401
Study site
Cincinnati, Ohio, 45219
Study site
Davenport, Iowa, 52803
Study site
Gastonia, North Carolina, 28054
Study site
Kansas City, Missouri, 64111
Study site
Mineola, New York, 11501
Study site
Minneapolis, Minnesota, 55407
Study site
Morgantown, West Virginia, 26505
Study site
Nashville, Tennessee, 37203
Study site
Orlando, Florida, 32806
Study site
Raleigh, North Carolina, 27610
Study site
Richmond, Virginia, 23225
Study site
Stony Brook, New York, 11794

Other trials in United States

Germany3 sites

Study site
Berlin
Study site
Heidelberg
Study site
Nuremberg

Other trials in Germany

Austria1 site

Study site
Linz

Other trials in Austria

Belgium1 site

Study site
Liège

Other trials in Belgium

Denmark1 site

Study site
Copenhagen

Other trials in Denmark

Netherlands1 site

Study site
Zwolle

Other trials in Netherlands

Norway1 site

Study site
Kristiansand

Other trials in Norway

About this study

Conditions: Coronary Artery Disease
Being tested: ICD
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)
Medical subject headings: Coronary Artery Disease, Non-ST Elevated Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ICDDevice
Subjects implanted with an ICD.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Implant to 2 years

Secondary outcomes (4)

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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Six-month follow-up visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Mar 2011

First posted2 Jul 2009 (estimated)
Study startApr 2008
Primary completionNov 2010
Study completionMar 2011

Why it stopped: Low observed spontaneous coronary event rate among enrolled subjects

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 175 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00930969
Sponsor's protocol ID: ST Detect
Acronym: ST Detect
Status last verified: Jan 2019
First submitted: 29 Jun 2009
Last updated: 18 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ST Segment Detection Study
ClinicalTrials.gov ID: NCT00930969
Acronym / sponsor ID: ST Detect / ST Detect
Conditions: Coronary Artery Disease
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)
Study type: Observational
Recruitment status: TerminatedReason stopped: Low observed spontaneous coronary event rate among enrolled subjects
Enrolment: 175 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: Nov 2010 (actual)
Study completion: Mar 2011 (actual)
First posted: 2 Jul 2009 (estimated)
Results: Posted 20 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects coming into the hospital or the emergency room needing a defibrillator device having had coronary artery disease as outlined in the inclusion criteria.

Key inclusion criteria (6 listed)

Subject is indicated for an ICD implantation
AND subject must meet ONE of the following:

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ICDSubjects implanted with an ICD.	Device	–

Primary outcome

Number of Participants With ST Segment Changes During Myocardial Infarction
Time frame: 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.

4 secondary outcomes

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

Results and safety

Results posted to the registry on 20 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ICD Indicated	175	137

Primary outcome: Number of Participants With ST Segment Changes During Myocardial Infarction

Time frame: Implant to 2 years

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline through 2 years.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ICD Indicated	86 of 175 (49.1%)	20 of 175 (11.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Coronary Artery Disease

Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
Active, not recruitingPhase 3
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
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RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

George Crossley, MD principal investigator

St. Thomas Research Institute and University of Tennessee College of Medicine Nashville, TN

Timothy Henry, MD principal investigator

Minneapolis Heart Institute Foundation Minneapolis, MN

25 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Medtronic Cardiac Rhythm and Heart Failure at 25 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Germany, Austria, Belgium, Denmark and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With ST Segment Changes During Myocardial Infarction (time frame: Implant to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00930969.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2019.