ST Segment Detection Study (ST Detect)

January 30, 2019 updated by: Medtronic Cardiac Rhythm and Heart Failure
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

175

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria
  • Belgium
      • Liege, Belgium
  • Denmark
      • Copenhagen, Denmark
  • Germany
      • Berlin, Germany
      • Heidelberg, Germany
      • Nuremberg, Germany
  • Netherlands
      • Zwolle, Netherlands
  • Norway
      • Kristiansand, Norway
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
    • Florida
      • Brandon, Florida, United States, 33511
      • Orlando, Florida, United States, 32806
    • Iowa
      • Davenport, Iowa, United States, 52803
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
    • Missouri
      • Kansas City, Missouri, United States, 64111
    • New York
      • Mineola, New York, United States, 11501
      • Stony Brook, New York, United States, 11794
    • North Carolina
      • Gastonia, North Carolina, United States, 28054
      • Raleigh, North Carolina, United States, 27610
    • Ohio
      • Cincinnati, Ohio, United States, 45219
    • Tennessee
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Austin, Texas, United States, 78705
    • Vermont
      • Burlington, Vermont, United States, 05401
    • Virginia
      • Richmond, Virginia, United States, 23225
    • West Virginia
      • Morgantown, West Virginia, United States, 26505

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Implant to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of Spontaneous Coronary Event
Time Frame: 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)
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
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.
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
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.
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
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.
Six-month follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

June 29, 2009

First Submitted That Met QC Criteria

June 30, 2009

First Posted (Estimate)

July 2, 2009

Study Record Updates

Last Update Posted (Actual)

February 18, 2019

Last Update Submitted That Met QC Criteria

January 30, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST Detect

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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