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NCT00985049 Clinical Trial

TRANSCRIBE (Transcriptomic Analysis of Left Ventricular Gene Expression)

Cardiovascular Diseases Clinical Trial

Official title:
Whole Genome Expression of Left Ventricular Myocardium During Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00985049
Other study ID # 2007p002323
Secondary ID R01HL118266
Status Recruiting
Phase
First received
Last updated
Start date March 2009
Est. completion date December 2024

Study information
Verified date February 2023
Source Brigham and Women's Hospital
Contact Jochen D Muehlschlegel, MD, MMSc
Phone 617-732-7330
Email jmuehlschlegel@partners.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 350
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (4)
Lead Sponsor Collaborator
Brigham and Women's Hospital American Heart Association, Harvard Medical School (HMS and HSDM), National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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 — View Citation

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 ischemi — View Citation

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. do — View Citation

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 ischem — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Differential gene expression Immediate
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