Echocardiographic Assessment of Cardiovascular Changes in Long Term Space Flight (NSBRI#3)
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 27, 2007 | ||||||||
| Last Updated Date | January 21, 2008 | ||||||||
| Start Date ICMJE | October 2003 | ||||||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Diagnostic 2D and 3D echocardiography [ Time Frame: 6-12 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00598598 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Endogenous gene expression [ Time Frame: 1 week ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Echocardiographic Assessment of Cardiovascular Changes in Long Term Space Flight | ||||||||
| Official Title ICMJE | Echocardiographic Assessment of Cardiovascular Adaptation and Counter Measures n Microgravity | ||||||||
| Brief Summary | The National Space Biomedical Research Institute is interested in learning more about heart function in space. One potential problem with long duration, manned space flight is muscle loss- including loss of heart muscle. One goal of our research is to help identify why this muscle loss occurs. We are interested in patients undergoing aortic valve surgery because this procedure is performed to correct a problem with the valve that may also change heart function. This change in heart function may provide information that is useful in understanding and potentially preventing the loss of cardiac muscle in space. Three patient groups will be studied, patients having surgery for aortic regurgitation, aortic stenosis, and coronary bypass. We are planing to perform this study on 30 patients, 10 in each group. The aim of this study is to continue our ongoing study of the magnitude and predictors of the changes in size of the left ventricle following acute volume and pressure unloading as a ground-based analog for manned space flight. |
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| Detailed Description | Among the most serious of the risks identified by NASA in the area of cardiovascular alterations are serious dysrhythmias and the development of orthostatic intolerance. Prolonged exposure to microgravity may lead to a reduction in cardiac performance, particularly during times of stress and that undiagnosed cardiovascular disease may manifest during long missions. The PI and colleagues have worked closely with NASA and NSBRI over the last six years to optimize use of ultrasound in the space program as an investigative modality, addressing fundamental cardiovascular problems in need of countermeasures development. We propose the following specific aim: To continue our ongoing study of the magnitude and predictors of LV mass regression following acute volume and pressure unloading as a ground-based analog for manned spaceflight. This work will continue to focus on patients undergoing aortic valve surgery, but exploit recent knowledge of the roles of cytokines and integrins involved in cardiac hypertrophy and regression as well as emerging technologies such as gene chip analysis. This work will be closely focused on risks and critical questions identified by the Cardiovascular Alterations Team as described in the Bioastronautics Critical Path Road Map Baseline Document. If successful, this project will enhance assessment of cardiac function during long duration missions and potentially suggest cytokine promoters or signal transduction pathways that could be targeted for cardiac atrophy countermeasures. In addition, we will continue to provide the facilities of our Core laboratory for access by investigators throughout the NASA and NSBRI programs in need of assistance in acquiring or analyzing ultrasonic data. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients coming to the Cleveland Clinic with aortic valve insufficiency or aortic valve stenosis, undering going repair or replacement, or patient undergoing coronary bypass surgery. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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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 | 30 | ||||||||
| Estimated Completion Date | December 2009 | ||||||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00598598 | ||||||||
| Other Study ID Numbers ICMJE | NSBRI NCC9-59-172 #3, IRB 6414, NSBRI SMS00404 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Jim Thomas, MD, Cleveland Clinic | ||||||||
| Study Sponsor ICMJE | The Cleveland Clinic | ||||||||
| Collaborators ICMJE | National Space Biomedical Research Institute | ||||||||
| Investigators ICMJE |
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| Information Provided By | The Cleveland Clinic | ||||||||
| Verification Date | January 2008 | ||||||||
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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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