Quantification of Myocardial Blood Flow by Positron Emission Tomography in Healthy Volunteers

• Conditions: Normal Healthy Volunteers Without Chronic Medical Conditions
• Interventions: Procedure: cardiac PET stress test

• Registration Number: NCT03895554
• Lead Sponsor: Ochsner Health System

Brief Summary

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

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 Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-03-27
• Last Update Submitted: 2019-03-27
• Study First Posted: 2019-03-29
• Last Update Posted: 2019-03-29
• Study Start: 2019-04-01
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal volunteers	cardiac PET stress test	Normal, healthy volunteers with undergo cardiac PET stress testing.

Primary Outcome Measures

Name	Time	Method
Absolute myocardial blood flow at rest and stress in cc/min/g	measured at the time of the cardiac PET stress scan	resting and stress MBF are in units of cc/min/g

Trial Locations

Locations (1)

Ochsner; 🇺🇸 New Orleans, Louisiana, United States