3D PET Myocardial Blood Flow and Rb82 Infusion Profiles

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Slow Infusion of Rubidium-82
* Drug: Slow Infusion of Rubidium-82
* Drug: Slow Infusion of Rubidium-82


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Normal volunteers<br>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<br>* Normal volunteers will receive weight based doses of Rb-82 infused as a slow infusion<br>* Other names: 20 mls/min of Rubidium-82;|
| Other: Clinical patients<br>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<br>* Clinical patients will receive weight based doses of Rb-82 infused as a slow infusion<br>* Other names: 20 mls/min of Rubidium-82;|
| Other: Infarcts<br>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<br>* Infarct volunteers will receive weight based doses of Rb-82 infused as a slow infusion<br>* Other names: 20 mls/min of Rubidium-82;|

What is the study measuring?
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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 | 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 | resting and stress myocardial blood flow in cc/min/g | 1 Day |