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3D PET Myocardial Blood Flow and Rb82 Infusion Profiles

Primary Purpose

Normal Healthy Volunteers Without Chronic Medical Conditions, Coronary Artery Disease, Cardiac Risk Factors

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Slow Infusion of Rubidium-82

About this trial

This is an interventional diagnostic trial for Normal Healthy Volunteers Without Chronic Medical Conditions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Normal Volunteers

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

The "clinical" population

Adults ≥18 years old able to give informed consent.
Any cardiac risk factor including hypertension, hyperlipidemia, diabetes mellitus or tobacco use OR
CAD defined by with history of PCI or CABG, Coronary Ca score>400, or dense coronary calcifications noted on chest CT
Ability to abstain from caffeine for 48 hours

The "infarct" population

Adults ≥18 years old able to give informed consent.
Prior cardiac PET scan demonstrating a fixed defect ≥ 15% of the LV myocardium with relative uptake ≤60% maximum uptake.
In addition, to the perfusion defect, each volunteer requires either:
- FDG PET or MRI viability studies confirming infarct OR
- akinesis and wall thinning on ECHO within the same territory as the PET defect in addition to Q-waves on ECG
Ability to abstain from caffeine for 48 hours

Exclusion Criteria:

Normal Volunteers

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 CAD (h/o PCI, MI or CABG) in men <55 or women <65
Severe claustrophobia
Positive urine pregnancy test
Inability to give informed consent
BMI ≥ 30 or BMI>25 and <30 provided waist to hip ratio >0.80 in women or 0.90 in men.

The "clinical" and "infarct" populations

Severe claustrophobia
Hemodynamic instability or unstable symptoms
Positive urine pregnancy test
Inability to give informed consent

Sites / Locations

Ochsner

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

Normal volunteers

Clinical patients

Infarcts

Arm Description

Normal participants will receive serial doses of Rb-82 administered as either a bolus (B) (gold standard) or slow infusion (SI). Under resting conditions, they will receive 3 weight based doses. The first two doses are randomly assigned B and SI. The third dose is either B or SI. Under stress conditions, they will receive 2 weight based doses that are randomly assigned B and SI.

Clinical patients participants will receive serial doses of Rb-82 administered as either a bolus (B) (gold standard) or slow infusion (SI). Under resting conditions, they will receive 3 weight based doses. The first two doses are randomly assigned B and SI. The third dose is either B or SI. Under stress conditions, they will receive 2 weight based doses that are randomly assigned B and SI.

Infarct participants will receive serial doses of Rb-82 administered as either a bolus (B) (gold standard) or slow infusion (SI). Under resting conditions, they will receive 3 weight based doses. The first two doses are randomly assigned B and SI. The third dose is either B or SI. Under stress conditions, they will receive 2 weight based doses that are randomly assigned B and SI.

Outcomes

Primary Outcome Measures

Resting and stress whole heart myocardial blood flow using the bolus infusion profile of Rubidium-82

resting and stress myocardial blood flow in cc/min/g

Secondary Outcome Measures

Resting and stress whole heart myocardial blood flow using the slow infusion profile of Rubidium-82

resting and stress myocardial blood flow in cc/min/g

Full Information

NCT ID

NCT05286593

First Posted

December 29, 2021

Last Updated

January 16, 2023

Sponsor

Ochsner Health System

Collaborators

Bracco Corporate

1. Study Identification

Unique Protocol Identification Number

NCT05286593

Brief Title

3D PET Myocardial Blood Flow and Rb82 Infusion Profiles

Official Title

Quantification of Myocardial Blood Flow by 3D Positron Emission Tomography With High and Low Rate Rb82 Infusion Profiles

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

December 28, 2021 (Actual)

Primary Completion Date

September 1, 2022 (Actual)

Study Completion Date

September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ochsner Health System

Collaborators

Bracco Corporate

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The investigators seek to test bolus infusions (50ml/min) vs. slow infusions (20 ml/min) of Rb-82 on metrics of coronary blood flow assessed on a modern 3D PET/CT.

Detailed Description

As perfusion metrics in the healthy volunteers, patients with risk factors and/or coronary artery disease and in tissue with transmural myocardial infarctions has been well defined AND same day test-retest variability minutes apart using a bolus infusion is ±10%, the investigators shall test 3 hypotheses. The first hypothesis is repeated same day test-retest coefficient of variation (COV) of whole heart rMBF and sMBF acquired using a bolus infusion profile (50 mls/min) on a modern 3D PET scanner falls within ± 10%. The second hypothesis is repeated same day test-retest COV of whole heart rMBF and sMBF acquired using a slow infusion activity profile (20 mls/min) on a modern 3D PET scanner falls within ± 10%. The third hypothesis is COV of whole heart rMBF and sMBF between bolus and slow activity profiles is ± 10% where the bolus is considered the standard on a modern 3D PET scanner. The investigators will test the different activity profiles on 3 distinct populations: Healthy volunteers Clinical volunteers with risk factors and/or CAD Volunteers with clinical infarcts.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Normal Healthy Volunteers Without Chronic Medical Conditions, Coronary Artery Disease, Cardiac Risk Factors, Myocardial Infarction

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Sequential Assignment

Model Description

All participants will receive a standard "high flow rate" weight based bolus of Rb-82 and a "low flow rate" weight based infusion of Rb-82. The bolus and infusion doses will be administered randomly at rest and stress however the bolus is considered the gold standard. In addition, under resting conditions, participants will also receive a third dose of Rb-82 that is either a bolus or low flow rate (assigned randomly).

Masking

None (Open Label)

Allocation

Randomized

Enrollment

98 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Normal volunteers

Arm Type

Other

Arm Description

Arm Title

Clinical patients

Arm Type

Other

Arm Description

Arm Title

Infarcts

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

Slow Infusion of Rubidium-82

Other Intervention Name(s)

20 mls/min of Rubidium-82

Intervention Description

Normal volunteers will receive weight based doses of Rb-82 infused as a slow infusion

Intervention Type

Drug

Intervention Name(s)

Slow Infusion of Rubidium-82

Other Intervention Name(s)

20 mls/min of Rubidium-82

Intervention Description

Clinical patients will receive weight based doses of Rb-82 infused as a slow infusion

Intervention Type

Drug

Intervention Name(s)

Slow Infusion of Rubidium-82

Other Intervention Name(s)

20 mls/min of Rubidium-82

Intervention Description

Infarct volunteers will receive weight based doses of Rb-82 infused as a slow infusion

Primary Outcome Measure Information:

Title

Resting and stress whole heart myocardial blood flow using the bolus infusion profile of Rubidium-82

Description

resting and stress myocardial blood flow in cc/min/g

Time Frame

1 day

Secondary Outcome Measure Information:

Title

Resting and stress whole heart myocardial blood flow using the slow infusion profile of Rubidium-82

Description

resting and stress myocardial blood flow in cc/min/g

Time Frame

1 Day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Normal Volunteers Adults ≥18 and <40 years old able to give informed consent. Ability to abstain from caffeine for 48 hours The "clinical" population Adults ≥18 years old able to give informed consent. Any cardiac risk factor including hypertension, hyperlipidemia, diabetes mellitus or tobacco use OR CAD defined by with history of PCI or CABG, Coronary Ca score>400, or dense coronary calcifications noted on chest CT Ability to abstain from caffeine for 48 hours The "infarct" population Adults ≥18 years old able to give informed consent. Prior cardiac PET scan demonstrating a fixed defect ≥ 15% of the LV myocardium with relative uptake ≤60% maximum uptake. In addition, to the perfusion defect, each volunteer requires either: FDG PET or MRI viability studies confirming infarct OR akinesis and wall thinning on ECHO within the same territory as the PET defect in addition to Q-waves on ECG Ability to abstain from caffeine for 48 hours Exclusion Criteria: Normal Volunteers 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 CAD (h/o PCI, MI or CABG) in men <55 or women <65 Severe claustrophobia Positive urine pregnancy test Inability to give informed consent BMI ≥ 30 or BMI>25 and <30 provided waist to hip ratio >0.80 in women or 0.90 in men. The "clinical" and "infarct" populations Severe claustrophobia Hemodynamic instability or unstable symptoms Positive urine pregnancy test Inability to give informed consent

Facility Information:

Facility Name

Ochsner

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70120

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

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1900224

Citation

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Links:

URL

https://doi.org/10.17996/anc.21-00137

Description

Quantification of Resting Myocardial Blood Flow Using Rubidum82 Positron Emission Tomography in Regions with MRI-Confirmed Myocardial Scar. Annals of Nuclear Cardiology.

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3D PET Myocardial Blood Flow and Rb82 Infusion Profiles

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