TRANSCRIBE (Transcriptomic Analysis of Left Ventricular Gene Expression)

• ClinicalTrials.gov Identifier: NCT00985049
• Recruitment Status: Recruiting
• First Posted: September 28, 2009
• Last Update Posted: May 11, 2021
• Sponsor: Brigham and Women's Hospital
• Collaborators: American Heart Association; Harvard Medical School (HMS and HSDM); National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Jochen Daniel Muehlschlegel, MD, Brigham and Women's Hospital

Tracking Information

• First Submitted Date: September 24, 2009
• First Posted Date: September 28, 2009
• Last Update Posted Date: May 11, 2021
• Study Start Date: March 2009
• Estimated Primary Completion Date: December 2024 (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
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified 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 *

• Heydarpour M, Ejiofor J, Gilfeather M, Stone G, Gorham J, Seidman CE, Seidman JG, Yammine M, Body SC, Aranki SF, Muehlschlegel JD. Molecular Genetics of Lidocaine-Containing Cardioplegia in the Human Heart During Cardiac Surgery. Ann Thorac Surg. 2018 Nov;106(5):1379-1387. doi: 10.1016/j.athoracsur.2018.06.016. Epub 2018 Jul 17.
• 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):e001534. doi: 10.1161/CIRCGENETICS.116.001534.
• Sigurdsson MI, Saddic L, Heydarpour M, Chang TW, Shekar P, Aranki S, Couper GS, Shernan SK, Seidman JG, Body SC, Muehlschlegel JD. Allele-specific expression in the human heart and its application to postoperative atrial fibrillation and myocardial ischemia. Genome Med. 2016 Dec 6;8(1):127. doi: 10.1186/s13073-016-0381-1.
• 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.

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 2024
• Estimated Primary Completion Date: December 2024 (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, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Jochen D Muehlschlegel, MD, MMSc; 617-732-7330; jmuehlschlegel@partners.org

• Listed Location Countries: United States

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
• Current Responsible Party: Jochen Daniel Muehlschlegel, MD, Brigham and Women's Hospital
• Original Responsible Party: Jochen Muehlschlegel, MD, Brigham and Women's Hospital
• Current Study Sponsor: Brigham and Women's Hospital
• Original Study Sponsor: Same as current

Collaborators

• American Heart Association
• Harvard Medical School (HMS and HSDM)
• 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 2021