Imaging and Omics for Cardiovascular Risk During NASA Deep Space Missions

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Myocardial contrast echocardiography

• Registration Number: NCT02465554
• Lead Sponsor: Oregon Health and Science University

Brief Summary

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

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-05
• Study First Posted: 2015-06-08
• Study Start: 2015-09
• Primary Completion: 2017-12-31
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-10
• Last Update Posted: 2018-01-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Atherosclerosis cohort	Myocardial contrast echocardiography	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.
No atherosclerosis cohort	Myocardial contrast echocardiography	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.

Primary Outcome Measures

Name	Time	Method
Omic patterns of atherosclerosis	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).

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States