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NSE-LVAD: Neuron Specific Enolase in Ventricular Assist Device Recipients

Sponsor
University of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT01643551
Collaborator
(none)
15
Enrollment
1
Location
13
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

An observational study of neuron specific enolase, as a marker of reperfusion injury, in LVAD recipients before and following VAD implantation.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Patients eligible for left ventricular assist device (LVAD) typically have severe heart failure, which is characterized by poor cardiac output. The relatively abrupt increase in cardiac output that follows implant of a LVAD may cause reperfusion injury. Furthermore, selected patients may have particularly severe consequences of such injury, including refractory acidosis and vasoplegia. Neuron specific enolase (NSE) has been established as a biomarker of reperfusion injury. We hypothesize that changes in NSE following LVAD will be greater than the changes in NSE noted in a control population of patients undergoing non-VAD cardiac surgery.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    15 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Neuron Specific Enolase in Ventricular Assist Device Recipients
    Study Start Date :
    Jun 1, 2012
    Actual Primary Completion Date :
    Jan 1, 2013
    Actual Study Completion Date :
    Jul 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    LVAD Group

    18 years and older Planning to undergo VAD implantation
    Cardiac Surgery Group

    18 years or older Planning to undergo valve or coronary bypass surgery

    Outcome Measures

    Primary Outcome Measures

    1. Neuron-Specific Enolase [Pre and post-surgery]

    Eligibility Criteria

    Criteria

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

    Group 1 - Pre-VAD implantation patients

    • 18 years and older

    • lanning to undergo VAD implantation Group 2 Cardiac Surgery Comparison Group

    • 18 years or older

    • Planning to undergo valve or coronary bypass surgery

    Exclusion Criteria:
    • Acute cerebrovascular infarction

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Minnesota Medical Center-Fairview Minneapolis Minnesota United States 55455

    Sponsors and Collaborators

    • University of Minnesota

    Investigators

    • Principal Investigator: Peter M Eckman, MD, University of Minnesota
    • Principal Investigator: Demitri Yannopoulos, MD, University of Minnesota

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT01643551
    Other Study ID Numbers:
    • 1204M12861
    First Posted:
    Jul 18, 2012
    Last Update Posted:
    Dec 18, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by University of Minnesota
    Heart Failure
    Left Ventricular Assist Device
    Reperfusion Injury
    Neuron Specific Enolase
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Dec 18, 2014