Imaging and Omics for Cardiovascular Risk During NASA Deep Space Missions

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02465554
• Other study ID #: IRB00011874
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 3, 2015
• Last updated: January 10, 2018
• Start date: September 2015
• Est. completion date: December 2018

Study information

• Verified date: January 2018
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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