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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
  Purpose
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
Cardiovascular Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Whole Genome Expression of Left Ventricular Myocardium During Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Jochen Daniel Muehlschlegel, MD, Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 200
Study Start Date: March 2009
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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
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
Contact: Jochen D Muehlschlegel, MD, MMSc 617-732-7330 jmuehlschlegel@partners.org
Contact: Simon C Body, MBChB MPH 617-732-7330 sbody@partners.org

Locations
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
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Jochen D. Muehlschlegel, MD Brigham and Women's Hospital