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3D PET Myocardial Blood Flow and Rb82 Infusion Profiles

Sponsor
Ochsner Health System (Other)
Overall Status
Recruiting
CT.gov ID
NCT05286593
Collaborator
Bracco Corporate (Industry)
85
Enrollment
1
Location
3
Arms
6
Anticipated Duration (Months)
14.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Slow Infusion of Rubidium-82
  • Drug: Slow Infusion of Rubidium-82
  • Drug: Slow Infusion of Rubidium-82
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
85 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention 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).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)
Primary Purpose:
Diagnostic
Official Title:
Quantification of Myocardial Blood Flow by 3D Positron Emission Tomography With High and Low Rate Rb82 Infusion Profiles
Actual Study Start Date :
Dec 28, 2021
Anticipated Primary Completion Date :
May 31, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

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

    		•
    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
    Clinical patients 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
    Infarct volunteers will receive weight based doses of Rb-82 infused as a slow infusion
    Other Names:
  • 20 mls/min of Rubidium-82

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Resting and stress whole heart myocardial blood flow using the bolus infusion profile of Rubidium-82 [1 day]

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

    Secondary Outcome Measures

    1. Resting and stress whole heart myocardial blood flow using the slow infusion profile of Rubidium-82 [1 Day]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ochsner New Orleans Louisiana United States 70120

    Sponsors and Collaborators

    • Ochsner Health System
    • Bracco Corporate

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Robert Bober, M.D., Director of Nuclear Cardiology, Ochsner Health System
    ClinicalTrials.gov Identifier:
    NCT05286593
    Other Study ID Numbers:
    • STUDY00001584
    First Posted:
    Mar 18, 2022
    Last Update Posted:
    Apr 27, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Myocardial Infarction
    Infarction

    Study Results

    No Results Posted as of Apr 27, 2022