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TRANSCRIBE (Transcriptomic Analysis of Left Ventricular Gene Expression)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Brigham and Women's Hospital
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00985049
First received: September 24, 2009
Last updated: July 27, 2016
Last verified: July 2016
History of Changes
  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:

U.S. FDA Resources

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 2017 (Final data collection date for primary outcome measure)
  Eligibility
Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Responsible Party: Jochen Daniel Muehlschlegel, MD, Associate Professor of Anesthesia, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00985049     History of Changes
Other Study ID Numbers: 2007p002323  R01HL118266 
Study First Received: September 24, 2009
Last Updated: July 27, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 28, 2016