TRANSCRIBE (Transcriptomic Analysis of Left Ventricular Gene Expression)
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ClinicalTrials.gov Identifier: NCT00985049 |
Recruitment Status :
Recruiting
First Posted : September 28, 2009
Last Update Posted : May 11, 2021
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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 | |||||
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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 |
Differential gene expression [ Time Frame: Immediate ] | ||||
Original Primary Outcome Measures | Not Provided | ||||
Change History | |||||
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 |
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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.
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Sampling Method | Non-Probability Sample | ||||
Study Population | Adult patients undergoing cardiac surgery | ||||
Condition | Cardiovascular Diseases | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
350 | ||||
Original Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 20 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT00985049 | ||||
Other Study ID Numbers | 2007p002323 R01HL118266 ( U.S. NIH Grant/Contract ) |
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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 |
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Investigators |
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PRS Account | Brigham and Women's Hospital | ||||
Verification Date | May 2021 |