Imaging and Omics for Cardiovascular Risk During NASA Deep Space Missions

NCT02465554 | Unknown DMC

• 1 other identifier: IRB00011874
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Procedure: Myocardial contrast echocardiography

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.

Procedure: Myocardial contrast echocardiography

Interventions

Myocardial contrast echocardiography PROCEDURE

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

Atherosclerosis cohort; No atherosclerosis cohort

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred for clinically-indicated CT coronary angiography.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 8, 2015
• Study Start: September 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 1, 2018
• Last Updated: January 12, 2018

Record last verified: 2018-01

Locations

US (1)