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TRANSCRIBE (Transcriptomic Analysis of Left Ventricular Gene Expression)

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ClinicalTrials.gov Identifier: NCT00985049
Recruitment Status : Recruiting
First Posted : September 28, 2009
Last Update Posted : May 11, 2021
Sponsor:
Collaborators:
American Heart Association
Harvard Medical School (HMS and HSDM)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jochen Daniel Muehlschlegel, MD, Brigham and Women's Hospital

Study Description
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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
Cardiovascular Diseases

Study Design
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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Whole Genome Expression of Left Ventricular Myocardium During Cardiac Surgery
Study Start Date : March 2009
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Differential gene expression [ Time Frame: Immediate ]

Biospecimen Retention:   Samples With DNA
DNA, EDTA , peripheral blood leucocytes, and left ventricle myocardium are all stored in -80C frreezer at BWH.

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients undergoing cardiac surgery
Criteria

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
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Information from the National Library of Medicine

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): NCT00985049


Contacts
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Contact: Jochen D Muehlschlegel, MD, MMSc 617-732-7330 jmuehlschlegel@partners.org

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Jochen D Muehlschlegel, MD         
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
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Principal Investigator: Jochen D. Muehlschlegel, MD Brigham and Women's Hospital
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2009    Key Record Dates
Last Update Posted: May 11, 2021
Last Verified: May 2021
Additional relevant MeSH terms:
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Cardiovascular Diseases