Imaging and Omics for Cardiovascular Risk During NASA Deep Space Missions

Oregon Health & Science University (OHSU)

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Procedure: Myocardial contrast echocardiography

Study type: Observational

Funder types: Other

Identifiers

NCT02465554

IRB00011874

Details and patient eligibility

About

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

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 35 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

No atherosclerosis cohort

Description:

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.

Treatment:

Procedure: Myocardial contrast echocardiography

Atherosclerosis cohort

Description:

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.

Treatment:

Procedure: Myocardial contrast echocardiography