Imaging and Omics for Cardiovascular Risk During NASA Deep Space Missions

January 10, 2018 updated by: Jonathan R. Lindner, MD, Oregon Health and Science University
The purpose of this study is to develop new approaches for screening astronauts for cardiovascular risk during deep space missions.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients referred for clinically-indicated CT coronary angiography.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Procedure: Myocardial contrast echocardiography
Myocardial contrast echocardiography will be performed to further stratify risk as described in the cohort section.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Omic patterns of atherosclerosis
Time Frame: 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).
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

December 31, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

June 3, 2015

First Submitted That Met QC Criteria

June 5, 2015

First Posted (Estimate)

June 8, 2015

Study Record Updates

Last Update Posted (Actual)

January 12, 2018

Last Update Submitted That Met QC Criteria

January 10, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00011874

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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