Status:
COMPLETED
3D PET Myocardial Blood Flow and Rb82 Infusion Profiles
Lead Sponsor:
Ochsner Health System
Collaborating Sponsors:
Bracco Corporate
Conditions:
Normal Healthy Volunteers Without Chronic Medical Conditions
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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-r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT05286593
Start Date
December 28 2021
End Date
September 30 2022
Last Update
January 18 2023
Active Locations (1)
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1
Ochsner
New Orleans, Louisiana, United States, 70120