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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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| First Received Date ICMJE | September 24, 2009 | ||||||||
| Last Updated Date | July 27, 2016 | ||||||||
| Start Date ICMJE | March 2009 | ||||||||
| Estimated Primary Completion Date | June 2017 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Differential gene expression [ Time Frame: Immediate ] | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00985049 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | TRANSCRIBE (Transcriptomic Analysis of Left Ventricular Gene Expression) | ||||||||
| Official Title ICMJE | 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 ICMJE | Observational | ||||||||
| Study Design ICMJE | 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 ICMJE | Cardiovascular Diseases | ||||||||
| Intervention ICMJE | 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 ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Estimated Completion Date | December 2018 | ||||||||
| Estimated Primary Completion Date | June 2017 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 20 Years and older (Adult, Senior) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
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| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00985049 | ||||||||
| Other Study ID Numbers ICMJE | 2007p002323 R01HL118266 ( US NIH Grant/Contract Award Number ) |
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| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product | Not Provided | ||||||||
| Plan to Share Data | Not Provided | ||||||||
| IPD Description | Not Provided | ||||||||
| Responsible Party | Jochen Daniel Muehlschlegel, MD, Brigham and Women's Hospital | ||||||||
| Study Sponsor ICMJE | Brigham and Women's Hospital | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Brigham and Women's Hospital | ||||||||
| Verification Date | July 2016 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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