3D PET Myocardial Blood Flow and Rb82 Infusion Profiles
Completed · Phase 4
Conditions studied: Normal Healthy Volunteers Without Chronic Medical Conditions, Coronary Artery Disease, Cardiac Risk Factors, Myocardial Infarction
In brief
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.
Key facts
- Study ID
- NCT05286593
- Run by
- Ochsner Health System
- People needed
- 98
- Starts
- 2021-12-28
- Expected to finish
- 2022-09-30
- Last updated by the study team
- 2023-01-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Ochsner — New Orleans, Louisiana, United States
Full record on ClinicalTrials.gov
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