Imaging and Omics for Cardiovascular Risk During NASA Deep Space Missions

NCT ID: NCT02465554

Last Updated: 2018-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-12-31

Brief Summary

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The purpose of this study is to develop new approaches for screening astronauts for cardiovascular risk during deep space missions.

Detailed Description

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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).

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Myocardial contrast echocardiography will be performed to further stratify risk as described in the cohort section.

Interventions

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Myocardial contrast echocardiography

Myocardial contrast echocardiography will be performed to further stratify risk as described in the cohort section.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Jonathan R. Lindner, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00011874

Identifier Type: -

Identifier Source: org_study_id

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