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TRANSCRIBE (Transcriptomic Analysis of Left Ventricular Gene Expression)

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT00985049
Collaborator
American Heart Association (Other), Harvard Medical School (HMS and HSDM) (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
350
Enrollment
1
Location
189
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Hypothesis: The investigators hypothesize that genetic variants will alter gene expression in response to ischemia during cardiopulmonary bypass. To test this, the investigators will be taking small pieces of heart tissue from patients undergoing heart surgery before and after this period of ischemia. This will be compared to blood gene expression in blood cells and analyzed with the patients' genetic profile. This might allow us to assess the amount of inflammation that occurs when patients are on the heart-lung machine as well as examine the effects genes have on this critical time period.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    350 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Whole Genome Expression of Left Ventricular Myocardium During Cardiac Surgery
    Study Start Date :
    Mar 1, 2009
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Differential gene expression [Immediate]

    Eligibility Criteria

    Criteria

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

    • Aged greater than 20 years

    • Undergoing aortic valve surgery with or without CABG surgery

    • Receive and apical vent as part of the surgery

    Exclusion Criteria:
    • Will not receive an apical left ventricular vent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brigham and Women's Hospital Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Brigham and Women's Hospital
    • American Heart Association
    • Harvard Medical School (HMS and HSDM)
    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

    • Principal Investigator: Jochen D. Muehlschlegel, MD, Brigham and Women's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jochen Daniel Muehlschlegel, MD, Associate Professor of Anesthesia, Brigham and Women's Hospital
    ClinicalTrials.gov Identifier:
    NCT00985049
    Other Study ID Numbers:
    • 2007p002323
    • R01HL118266
    First Posted:
    Sep 28, 2009
    Last Update Posted:
    May 11, 2021
    Last Verified:
    May 1, 2021
    Additional relevant MeSH terms:
    Cardiovascular Diseases

    Study Results

    No Results Posted as of May 11, 2021