ST Monitoring to Detect Acute Coronary Syndrome Events in Implantable Cardioverter Defibrillator Patients (AnalyzeST)
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ClinicalTrials.gov Identifier: NCT01424722 |
Recruitment Status
:
Terminated
First Posted
: August 29, 2011
Last Update Posted
: August 4, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Artery Disease | Device: Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2258 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | ST Monitoring to Detect ACS Events in ICD Patients |
Actual Study Start Date : | August 2011 |
Actual Primary Completion Date : | June 2017 |
Actual Study Completion Date : | June 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: ST Monitoring Feature |
Device: Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices
Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.
Other Name: ST Monitoring Feature
|
- Percent of patients who experience a false positive ST detection in 12 months FU [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
Eligible patients will meet all of the following:
- Have an indication for an ICD implantation or pulse generator change
- Have documented coronary artery disease. Documented coronary artery disease is defined as having at least one of the following present a) evidence of a prior MI on ECG and/or cardiac enzymes, b) prior revascularization (by coronary artery bypass grafting or percutaneous coronary intervention) c) angina and/or ST-T wave abnormalities indicative of ischemia on exercise stress test, nuclear stress test, or echo stress test, or d) coronary artery disease diagnosed by coronary angiography.
- Willing and able to comply with protocol requirements, including keeping all required visits
- Willing to participate in the study and able to sign an IRB approved informed consent form
- Be at least 18 years of age when enrolled in the study
Exclusion Criteria:
-
Patients will be excluded if they meet any of the following:
- Are pacemaker dependent (defined as a need for ventricular pacing ≥ 20% of the time)
- Have NYHA Class IV Heart Failure
- Have persistent or permanent atrial fibrillation
- Have a known history of intermittent Bundle Branch Block
- Pregnant or planning a pregnancy during the study participation
- Have a life expectancy of < 1 year due to any condition
- Are currently participating in a clinical investigation that includes an active treatment arm.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01424722

Principal Investigator: | Michael Gibson, MD | Boston Clinical Research Institute |
Responsible Party: | St. Jude Medical |
ClinicalTrials.gov Identifier: | NCT01424722 History of Changes |
Other Study ID Numbers: |
CRD_420 |
First Posted: | August 29, 2011 Key Record Dates |
Last Update Posted: | August 4, 2017 |
Last Verified: | August 2017 |
Keywords provided by St. Jude Medical:
ICD Indicated patients documented CAD |
Additional relevant MeSH terms:
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |