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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

Tracking Information
First Submitted Date September 24, 2009
First Posted Date September 28, 2009
Last Update Posted Date May 11, 2021
Study Start Date March 2009
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 7, 2013)
Differential gene expression [ Time Frame: Immediate ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title TRANSCRIBE (Transcriptomic Analysis of Left Ventricular Gene Expression)
Official Title Whole Genome Expression of Left Ventricular Myocardium During Cardiac Surgery
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
DNA, EDTA , peripheral blood leucocytes, and left ventricle myocardium are all stored in -80C frreezer at BWH.
Sampling Method Non-Probability Sample
Study Population Adult patients undergoing cardiac surgery
Condition Cardiovascular Diseases
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 8, 2018)
350
Original Estimated Enrollment
 (submitted: September 25, 2009)
60
Estimated Study Completion Date December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jochen D Muehlschlegel, MD, MMSc 617-732-7330 jmuehlschlegel@partners.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00985049
Other Study ID Numbers 2007p002323
R01HL118266 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Jochen Daniel Muehlschlegel, MD, Brigham and Women's Hospital
Original Responsible Party Jochen Muehlschlegel, MD, Brigham and Women's Hospital
Current Study Sponsor Brigham and Women's Hospital
Original Study Sponsor Same as current
Collaborators
  • 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
PRS Account Brigham and Women's Hospital
Verification Date May 2021