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TRANSCRIBE (Transcriptomic Analysis of Left Ventricular Gene Expression)
This study is currently recruiting participants.
Verified July 2016 by Jochen Daniel Muehlschlegel, MD, Brigham and Women's Hospital
Sponsor:
Brigham and Women's Hospital
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: July 27, 2016
Last verified: July 2016
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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:
Further study details as provided by Jochen Daniel Muehlschlegel, MD, Brigham and Women's Hospital:
Primary Outcome Measures:
- Differential gene expression [ Time Frame: Immediate ]
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 2017 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00985049
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | September 24, 2009 |
| Last Updated: | July 27, 2016 |
Additional relevant MeSH terms:
|
Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 22, 2017