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LIFEMARKER: Circulating Biomarkers and Ventricular Tachyarrhythmia

Sponsor
Ochsner Health System (Other)
Overall Status
Completed
CT.gov ID
NCT01892462
Collaborator
Boston Scientific Corporation (Industry)
220
Enrollment
1
Location
52
Actual Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether levels of inflammatory markers in circulating blood can correlate with risk for dangerous heart rhythms. Patients with systolic heart failure, which has been shown to increase risk for dangerous heart rhythms, will be enrolled. All subjects will have an implantable cardioverter-defibrillator (ICD) in place, which allows regular evaluation of heart rhythm.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    If you agree to be in this study, you will be asked to the following things:

    • you will come into the EP device clinic every three months for one year to have your device interrogated and will complete an EKG

    • you will have labs drawn to measure levels of certain markers of inflammation in the body. This information will be used to identify new ways to test for risk of abnormal heart rhythms and other heart disease

    • you will review your medications with the study coordinator and along with any recent illnesses or hospitalizations

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    220 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Circulating Biomarkers and Ventricular Tachyarrhythmia
    Actual Study Start Date :
    Jun 1, 2012
    Actual Primary Completion Date :
    Oct 1, 2016
    Actual Study Completion Date :
    Oct 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. to evaluate a large population of heart failure patients with regard to circulating biomarkers and rates of subsequent ventricular arrhythmias. [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • left ventricular ejection fraction [LVEF] <=35%

    • ICD implant

    Exclusion Criteria:

    • Recent myocardial infarction (12 weeks)

    • Recent revascularization (12 weeks)

    • Recent hospitalization for any cause (6 weeks)

    • History of rheumatologic disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ochsner Health System New Orleans Louisiana United States 70121

    Sponsors and Collaborators

    • Ochsner Health System
    • Boston Scientific Corporation

    Investigators

    • Principal Investigator: Daniel P Morin, MD MPH, Ochsner Medical Foundation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Daniel P Morin, MD MPH FHRS, Cardiac Electrophysiologist, Director of Cardiovascular Research, Ochsner Health System
    ClinicalTrials.gov Identifier:
    NCT01892462
    Other Study ID Numbers:
    • ISRCRM400003
    First Posted:
    Jul 4, 2013
    Last Update Posted:
    Apr 7, 2017
    Last Verified:
    Apr 1, 2017
    Additional relevant MeSH terms:
    Cardiomyopathies
    Tachycardia
    Tachycardia, Ventricular
    Ventricular Fibrillation

    Study Results

    No Results Posted as of Apr 7, 2017