3D PET Myocardial Blood Flow and Rb82 Infusion Profiles

January 16, 2023 updated by: Robert Bober, M.D., Ochsner Health System

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. Healthy volunteers
  2. Clinical volunteers with risk factors and/or CAD
  3. Volunteers with clinical infarcts.

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70120
        • Ochsner

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Normal volunteers
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.
Drug: Slow Infusion of Rubidium-82
Normal volunteers will receive weight based doses of Rb-82 infused as a slow infusion
Other Names:
  • 20 mls/min of Rubidium-82
Drug: Slow Infusion of Rubidium-82
Clinical patients will receive weight based doses of Rb-82 infused as a slow infusion
Other Names:
  • 20 mls/min of Rubidium-82
Drug: Slow Infusion of Rubidium-82
Infarct volunteers will receive weight based doses of Rb-82 infused as a slow infusion
Other Names:
  • 20 mls/min of Rubidium-82
Other: Clinical patients
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.
Drug: Slow Infusion of Rubidium-82
Normal volunteers will receive weight based doses of Rb-82 infused as a slow infusion
Other Names:
  • 20 mls/min of Rubidium-82
Drug: Slow Infusion of Rubidium-82
Clinical patients will receive weight based doses of Rb-82 infused as a slow infusion
Other Names:
  • 20 mls/min of Rubidium-82
Drug: Slow Infusion of Rubidium-82
Infarct volunteers will receive weight based doses of Rb-82 infused as a slow infusion
Other Names:
  • 20 mls/min of Rubidium-82
Other: Infarcts
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.
Drug: Slow Infusion of Rubidium-82
Normal volunteers will receive weight based doses of Rb-82 infused as a slow infusion
Other Names:
  • 20 mls/min of Rubidium-82
Drug: Slow Infusion of Rubidium-82
Clinical patients will receive weight based doses of Rb-82 infused as a slow infusion
Other Names:
  • 20 mls/min of Rubidium-82
Drug: Slow Infusion of Rubidium-82
Infarct volunteers will receive weight based doses of Rb-82 infused as a slow infusion
Other Names:
  • 20 mls/min of Rubidium-82

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting and stress whole heart myocardial blood flow using the bolus infusion profile of Rubidium-82
Time Frame: 1 day
resting and stress myocardial blood flow in cc/min/g
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting and stress whole heart myocardial blood flow using the slow infusion profile of Rubidium-82
Time Frame: 1 Day
resting and stress myocardial blood flow in cc/min/g
1 Day

Collaborators and Investigators

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

Sponsor

Ochsner Health System

Collaborators

Bracco Corporate

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

Helpful Links

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 (Actual)

December 28, 2021

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

December 29, 2021

First Submitted That Met QC Criteria

March 9, 2022

First Posted (Actual)

March 18, 2022

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 16, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001584

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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