Clinical trial NCT05286593: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Normal Healthy Volunteers Without Chronic Medical Conditions
Coronary Artery Disease
Cardiac Risk Factors
Myocardial Infarction
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
Collaborators: name: Bracco Corporate
First posted: 2022-03-18
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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).
Primary purpose: DIAGNOSTIC

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:

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

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

Primary outcomes:
measure: Resting and stress whole heart myocardial blood flow using the bolus infusion profile of Rubidium-82
timeFrame: 1 day
Secondary outcomes:
measure: Resting and stress whole heart myocardial blood flow using the slow infusion profile of Rubidium-82
timeFrame: 1 Day
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner
state: Louisiana
Study officials:
References:
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