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TRANSCRIBE (Transcriptomic Analysis of Left Ventricular Gene Expression)

This study is currently recruiting participants.
Verified July 2017 by Jochen Daniel Muehlschlegel, MD, Brigham and Women's Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT00985049
First Posted: September 28, 2009
Last Update Posted: July 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
American Heart Association
Harvard Medical School
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jochen Daniel Muehlschlegel, MD, Brigham and Women's Hospital
September 24, 2009
September 28, 2009
July 19, 2017
March 2009
June 2020   (Final data collection date for primary outcome measure)
Differential gene expression [ Time Frame: Immediate ]
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Complete list of historical versions of study NCT00985049 on ClinicalTrials.gov Archive Site
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TRANSCRIBE (Transcriptomic Analysis of Left Ventricular Gene Expression)
Whole Genome Expression of Left Ventricular Myocardium During Cardiac Surgery
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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:
DNA, EDTA , peripheral blood leucocytes, and left ventricle myocardium are all stored in -80C frreezer at BWH.
Non-Probability Sample
Adult patients undergoing cardiac surgery
Cardiovascular Diseases
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2020
June 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact: Jochen D Muehlschlegel, MD, MMSc 617-732-7330 jmuehlschlegel@partners.org
Contact: Simon C Body, MBChB MPH 617-732-7330 sbody@partners.org
United States
 
 
NCT00985049
2007p002323
R01HL118266 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Jochen Daniel Muehlschlegel, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
  • American Heart Association
  • Harvard Medical School
  • National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Jochen D. Muehlschlegel, MD Brigham and Women's Hospital
Brigham and Women's Hospital
July 2017