Imaging and Omics for Cardiovascular Risk During NASA Deep Space Missions
January 10, 2018 updated by: Jonathan R. Lindner, MD, Oregon Health and Science University
The purpose of this study is to develop new approaches for screening astronauts for cardiovascular risk during deep space missions.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oregon
-
Portland, Oregon, United States
- Oregon Health & Science University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients referred for clinically-indicated CT coronary angiography.
Description
Inclusion Criteria:
- Patients referred for clinically indicated CT coronary angiography within 6 months
- No obstructive coronary plaque and an Agatston score of 0 or At least one obstructive coronary plaque <50% diameter and one other high risk feature on CT-A (positive remodeling, scattered calcification, low Hounsfield units, or "napkin ring" sign.
Exclusion Criteria:
- Known CAD or other atherosclerotic disease
- Valvular heart disease (moderate or more) and congenital heart disease
- Heart failure
- Pregnancy
- Allergy to ultrasound contrast agent.
- Right to left shunt
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
Myocardial contrast echocardiography will be performed to further stratify risk as described in the cohort section.
|
|
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.
|
Myocardial contrast echocardiography will be performed to further stratify risk as described in the cohort section.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Omic patterns of atherosclerosis
Time Frame: 2 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Actual)
December 31, 2017
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
June 3, 2015
First Submitted That Met QC Criteria
June 5, 2015
First Posted (Estimate)
June 8, 2015
Study Record Updates
Last Update Posted (Actual)
January 12, 2018
Last Update Submitted That Met QC Criteria
January 10, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00011874
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.