Quantification of Myocardial Blood Flow by Positron Emission Tomography in Healthy Volunteers (PET Normals)

March 27, 2019 updated by: Robert Bober, M.D., Ochsner Health System
To establish quantitative values of myocardial blood flow (MBF) in normal, healthy volunteers .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

We seek to establish quantitative values of myocardial blood flow in 20 normal, healthy volunteers using our existing 2D PET camera (Positron Attrius) and invasively validated software package (HeartSee) in order to 1) establish institutional values for which clinical patients can be compared to and 2) add to the collective data of the scientific community. Values to be measured will be resting myocardial blood flow (MBF), stress MBF and coronary flow reserve.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70120
        • Ochsner
        • Contact:
        • Contact:
        • Principal Investigator:
          • Robert Bober, MD
        • Sub-Investigator:
          • Nichole Polin, MD
        • Sub-Investigator:
          • Merrill Stewart, MD
        • Sub-Investigator:
          • Joseph Englert, MD

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Volunteers will be selected from the local community.

Description

Inclusion Criteria:

  • Adults ≥18 and <40 years old
  • Participants must be able to give informed consent.
  • Ability to abstain from caffeine for 48 hours

Exclusion Criteria:

  • Any chronic cardiac disease or condition (e.g. hypertension, hyperlipidemia)
  • Any chronic systemic disease or condition (e.g. diabetes, systemic lupus, rheumatoid arthritis)
  • Tobacco use
  • Family history in a first degree relative with clinical coronary artery disease (history of myocardial infarctio, percutaneous intervention or coronary artery bypass grafting) in men <55 years old or women <65 years old
  • Severe claustrophobia
  • Positive urine pregnancy test
  • Inability to give informed consent

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
Normal volunteers
Normal, healthy volunteers with undergo cardiac PET stress testing.
Procedure: cardiac PET stress test
Volunteers will undergo cardiac PET stress testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute myocardial blood flow at rest and stress in cc/min/g
Time Frame: measured at the time of the cardiac PET stress scan
resting and stress MBF are in units of cc/min/g
measured at the time of the cardiac PET stress scan

Collaborators and Investigators

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

Sponsor

Ochsner Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

April 1, 2019

Primary Completion (Anticipated)

September 30, 2019

Study Completion (Anticipated)

September 30, 2019

Study Registration Dates

First Submitted

March 27, 2019

First Submitted That Met QC Criteria

March 27, 2019

First Posted (Actual)

March 29, 2019

Study Record Updates

Last Update Posted (Actual)

March 29, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00000188

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Intention to publish the data in peer reviewed journal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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