Cardiac Risk Factors, Coronary Artery Disease, Myocardial Infarction, Normal Healthy Volunteers Without Chronic Medical Conditions
Conditions
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.
Interventions
DRUGSlow Infusion of Rubidium-82
Normal volunteers will receive weight based doses of Rb-82 infused as a slow infusion
Sponsors
Bracco Corporate
Ochsner Health System
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed