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

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ClinicalTrials.gov Identifier: NCT03895554
Recruitment Status : Not yet recruiting
First Posted : March 29, 2019
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Robert Bober, M.D., Ochsner Health System

Brief Summary:
To establish quantitative values of myocardial blood flow (MBF) in normal, healthy volunteers .

Condition or disease Intervention/treatment
Normal Healthy Volunteers Without Chronic Medical Conditions Procedure: cardiac PET stress test

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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Quantification of Myocardial Blood Flow by Positron Emission Tomography in Healthy Volunteers
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Volunteers will be selected from the local community.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03895554


Contacts
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Contact: Robert M Bober, MD 5048426821 rbober@ochsner.org
Contact: Hunter McDaniel 5047033272 hunter.mcdaniel@ochsner.org

Locations
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United States, Louisiana
Ochsner Not yet recruiting
New Orleans, Louisiana, United States, 70120
Contact: Robert Bober, MD    504-842-6821    rbober@ochsner.org   
Contact: Hunter McDaniel    504.703.3272    hunter.mcdaniel@ochsner.org   
Principal Investigator: Robert Bober, MD         
Sub-Investigator: Nichole Polin, MD         
Sub-Investigator: Merrill Stewart, MD         
Sub-Investigator: Joseph Englert, MD         
Sponsors and Collaborators
Ochsner Health System

Publications:

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Responsible Party: Robert Bober, M.D., Director of Cardiac Molecular Imaging, Ochsner Health System
ClinicalTrials.gov Identifier: NCT03895554     History of Changes
Other Study ID Numbers: STUDY00000188
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Intention to publish the data in peer reviewed journal.

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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