ST Segment Detection Study

Coronary Artery Disease Clinical Trial

— ST Detect  

Official title:

ST Segment Detection Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00930969
• Other study ID #: ST Detect
• Status: Terminated
• Start date: April 2008
• Est. completion date: March 2011

Study information

• Verified date: January 2019
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 artery disease.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 175
• Est. completion date: March 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• ICD
Subjects implanted with an ICD.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Denmark,  Germany,  Netherlands,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Implant to 2 years
Secondary	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)	Implant to 2 years
Secondary	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.	One-month follow-up visit
Secondary	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.	Implant to 2 years
Secondary	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.	Six-month follow-up visit