Clinical trial NCT00985049: TRANSCRIBE (Transcriptomic Analysis of Left Ventricular Gene Expression)
Official title: Whole Genome Expression of Left Ventricular Myocardium During Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: Harvard Medical School (HMS and HSDM)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2009-09-28
Enrollment: 350
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing 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.


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

Primary outcomes:
measure: Differential gene expression
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Johns Hopkins University
name: Jochen D. Muehlschlegel, MD, MMSc, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Sergey Karamnov, MD
role: STUDY_DIRECTOR
References:
citation: 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.
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 ischemia. Cardiovasc Diabetol. 2017 Jul 7;16(1):87. doi: 10.1186/s12933-017-0567-x.
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. doi: 10.1161/CIRCGENETICS.116.001534.
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 ischemia. Genome Med. 2016 Dec 6;8(1):127. doi: 10.1186/s13073-016-0381-1.
citation: 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.