TRANSCRIBE (Transcriptomic Analysis of Left Ventricular Gene Expression)

This study is currently recruiting participants.
Verified April 2014 by Brigham and Women's Hospital
Sponsor:
Collaborators:
American Heart Association
Harvard Medical School
Information provided by (Responsible Party):
Jochen Daniel Muehlschlegel, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00985049
First received: September 24, 2009
Last updated: April 15, 2014
Last verified: April 2014
  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 Brigham and Women's Hospital:

Primary Outcome Measures:
  • Differential gene expression [ Time Frame: Immediate ] [ Designated as safety issue: No ]

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 2018
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Jochen D. Muehlschlegel, MD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Jochen Daniel Muehlschlegel, MD, Assistant Professor of Anesthesia, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00985049     History of Changes
Other Study ID Numbers: 2007p002323
Study First Received: September 24, 2009
Last Updated: April 15, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014