Clinical trial NCT00930969: ST Segment Detection Study
Official title: ST Segment Detection Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
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)
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2009-07-02
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With ST Segment Changes During Myocardial Infarction
timeFrame: Implant to 2 years
Secondary outcomes:
measure: Occurrence of Spontaneous Coronary Event
timeFrame: Implant to 2 years
measure: ST Segment Changes Measured by an ICD in Subjects Who Test Positive for Ischemia During an Exercise Stress Test
timeFrame: One-month follow-up visit
measure: 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.
timeFrame: Implant to 2 years
measure: Participants That Consented to Wear a Holter Monitor for a Period of 24 Hours to Collect Heart Sounds Data.
timeFrame: Six-month follow-up visit
Other outcomes:
Locations:
city: Anchorage
country: United States
state: Alaska
city: Brandon
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Davenport
country: United States
state: Iowa
city: Boston
country: United States
state: Massachusetts
city: Minneapolis
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Mineola
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Gastonia
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Richmond
country: United States
state: Virginia
city: Morgantown
country: United States
state: West Virginia
city: Linz
country: Austria
city: Liege
country: Belgium
city: Copenhagen
country: Denmark
city: Berlin
country: Germany
city: Heidelberg
country: Germany
city: Nuremberg
country: Germany
city: Zwolle
country: Netherlands
city: Kristiansand
country: Norway
Study officials:
affiliation: St. Thomas Research Institute and University of Tennessee College of Medicine Nashville, TN
name: George Crossley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Minneapolis Heart Institute Foundation Minneapolis, MN
name: Timothy Henry, MD
role: PRINCIPAL_INVESTIGATOR
References: