Quantification of Myocardial Blood Flow by Positron Emiss... | NCT03895554

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

NCT03895554

Sponsor

Ochsner Health System

Status

Unknown status

Last Update Posted

Mar 29, 2019Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Normal Healthy Volunteers Without Chronic Medical Conditions

Interventions

cardiac PET stress test

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Estimated

Primary Completion Date

Sep 30, 2019Estimated

Completion Date

Sep 30, 2019Estimated

First Submitted Date

Mar 27, 2019

First Submission Date that Met QC Criteria

Mar 27, 2019

First Posted Date

Mar 29, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2019

Last Update Posted Date

Mar 29, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Robert Bober, M.D., Director of Cardiac Molecular Imaging, Ochsner Health SystemPrincipal Investigator

Lead Sponsor

Ochsner Health SystemOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal volunteers		Normal, healthy volunteers with undergo cardiac PET stress testing.	Procedure: cardiac PET stress test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cardiac PET stress test	Procedure	Volunteers will undergo cardiac PET stress testing	Normal volunteers

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Volunteers will be selected from the local community.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Robert M Bober, MD	Contact	5048426821		rbober@ochsner.org
Hunter McDaniel	Contact	5047033272		hunter.mcdaniel@ochsner.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ochsner		New Orleans	Louisiana	70120	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
1900224	Background	Araujo LI, Lammertsma AA, Rhodes CG, McFalls EO, Iida H, Rechavia E, Galassi A, De Silva R, Jones T, Maseri A. Noninvasive quantification of regional myocardial blood flow in coronary artery disease with oxygen-15-labeled carbon dioxide inhalation and positron emission tomography. Circulation. 1991 Mar;83(3):875-85. doi: 10.1161/01.cir.83.3.875.
2788669

Type	Date	Date Unknown
Release	Apr 11, 2023
Reset	Jan 10, 2024