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The purpose of this study is to develop new approaches for screening astronauts for cardiovascular risk during deep space missions.
The purpose of this study is to develop new approaches for screening astronauts for cardiovascular risk during deep space missions. In this protocol, two different forms of imaging will be used to evaluate coronary plaque development (CT coronary angiography) and microvascular function (myocardial contrast echocardiography) to stratify CV risk. Based on this stratification, "omic" patterns (targeted metabolomics, lipidomic, and whole genome sequencing) will be assessed to determine whether there are any patterns that can add to existing predictive models. Outcomes measures will involve correlation of "omic" patterns to incremental risk scaling from lowest (no plaque and normal endothelial function) to highest (+ plaque and endothelial dysfunction).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No atherosclerosis cohort | This group will have patients who have undergone clinically-indicated CT coronary angiography (CT-A) and who have no plaque and an Agatston score of "0". They will then undergo a myocardial contrast echocardiography study during vasodilator stress to subdivide risk further into "No atherosclerosis/endothelial function normal" and "No atherosclerosis/endothelial function abnormal". Blood will then be collected for metabolomics, lipidomic and whole genome sequencing. |
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| Atherosclerosis cohort | This group will have patients who have undergone clinically-indicated CT coronary angiography (CT-A) and who have non-critical plaque (<50% diameter) and at least 1 high risk feature according to the ROMICAT indices. They will then undergo a myocardial contrast echocardiography study during vasodilator stress to subdivide risk further into "atherosclerosis/endothelial function normal" and "atherosclerosis/endothelial function abnormal". Blood will then be collected for metabolomics, lipidomic and whole genome sequencing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myocardial contrast echocardiography | Procedure | Myocardial contrast echocardiography will be performed to further stratify risk as described in the cohort section. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Omic patterns of atherosclerosis | In this study, "outcomes" are essentially pre-determined by the patient population according to imaging stratification. Omic patterns of will be assessed by advanced informatics modeling (Random Forest analysis) to determine metabolomic, genomic, and lipidomic patterns that vary according to incremental risk scaling from lowest (no plaque and normal endothelial function) to highest (+ plaque and endothelial dysfunction). | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patients referred for clinically-indicated CT coronary angiography.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 5, 2019 | |
| Reset | Aug 9, 2019 | |
| Release | Jun 2, 2020 | |
| Reset | Jun 15, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 5, 2019 | Aug 9, 2019 | |||
| Jun 2, 2020 |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Jun 15, 2020 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |