TRANSCRIBE (Transcriptomic Analysis of Left Ventricular Gene Expression)

This study is currently recruiting participants. (see Contacts and Locations)

Verified January 2015 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: January 26, 2015

Last verified: January 2015

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:

MedlinePlus related topics: Genes and Gene Therapy

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 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

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

No publications provided


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:	January 26, 2015
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on March 03, 2015

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