TRANSCRIBE (Transcriptomic Analysis of Left Ventricular Gene Expression)

Tracking Information
First Submitted Date	September 24, 2009
First Posted Date	September 28, 2009
Last Update Posted Date	May 10, 2018
Study Start Date	March 2009
Estimated Primary Completion Date	June 2020 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: August 7, 2013)	Differential gene expression [ Time Frame: Immediate ]
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00985049 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	TRANSCRIBE (Transcriptomic Analysis of Left Ventricular Gene Expression)
Official Title	Whole Genome Expression of Left Ventricular Myocardium During Cardiac Surgery
Brief Summary	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.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA; Description: DNA, EDTA , peripheral blood leucocytes, and left ventricle myocardium are all stored in -80C frreezer at BWH.
Sampling Method	Non-Probability Sample
Study Population	Adult patients undergoing cardiac surgery
Condition	Cardiovascular Diseases
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Saddic LA, Nicoloro SM, Gupta OT, Czech MP, Gorham J, Shernan SK, Seidman CE, Seidman JG, Aranki SF, Body SC, Fitzgibbons TP, Muehlschlegel JD. Joint analysis of left ventricular expression and circulating plasma levels of Omentin after myocardial ischemia. Cardiovasc Diabetol. 2017 Jul 7;16(1):87. doi: 10.1186/s12933-017-0567-x.; Saddic LA, Sigurdsson MI, Chang TW, Mazaika E, Heydarpour M, Shernan SK, Seidman CE, Seidman JG, Aranki SF, Body SC, Muehlschlegel JD. The Long Noncoding RNA Landscape of the Ischemic Human Left Ventricle. Circ Cardiovasc Genet. 2017 Jan;10(1). pii: e001534. doi: 10.1161/CIRCGENETICS.116.001534.; Saddic LA, Chang TW, Sigurdsson MI, Heydarpour M, Raby BA, Shernan SK, Aranki SF, Body SC, Muehlschlegel JD. Integrated microRNA and mRNA responses to acute human left ventricular ischemia. Physiol Genomics. 2015 Oct;47(10):455-62. doi: 10.1152/physiolgenomics.00049.2015. Epub 2015 Jul 14.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Recruiting
Estimated Enrollment; (submitted: May 8, 2018)	350
Original Estimated Enrollment; (submitted: September 25, 2009)	60
Estimated Study Completion Date	December 2020
Estimated Primary Completion Date	June 2020 (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender	Sexes Eligible for Study: All
Ages	20 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact: Jochen D Muehlschlegel, MD, MMSc 617-732-7330 jmuehlschlegel@partners.org
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT00985049
Other Study ID Numbers	2007p002323; R01HL118266 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Jochen Daniel Muehlschlegel, MD, Brigham and Women's Hospital
Study Sponsor	Brigham and Women's Hospital
Collaborators	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
PRS Account	Brigham and Women's Hospital
Verification Date	May 2018