Coronary Artery Disease Clinical Trial
Official title:
Quantification of Myocardial Blood Flow by 3D Positron Emission Tomography With High and Low Rate Rb82 Infusion Profiles
Verified date | January 2023 |
Source | Ochsner Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 98 |
Est. completion date | September 30, 2022 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Ochsner | New Orleans | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Ochsner Health System | Bracco Corporate |
United States,
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Gould KL, Bui L, Kitkungvan D, Patel MB. Reliability and Reproducibility of Absolute Myocardial Blood Flow: Does It Depend on the PET/CT Technology, the Vasodilator, and/or the Software? Curr Cardiol Rep. 2021 Jan 22;23(3):12. doi: 10.1007/s11886-021-01449-8. — View Citation
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Kitkungvan D, Johnson NP, Roby AE, Patel MB, Kirkeeide R, Gould KL. Routine Clinical Quantitative Rest Stress Myocardial Perfusion for Managing Coronary Artery Disease: Clinical Relevance of Test-Retest Variability. JACC Cardiovasc Imaging. 2017 May;10(5):565-577. doi: 10.1016/j.jcmg.2016.09.019. Epub 2016 Dec 21. — View Citation
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Renaud JM, DaSilva JN, Beanlands RS, DeKemp RA. Characterizing the normal range of myocardial blood flow with (8)(2)rubidium and (1)(3)N-ammonia PET imaging. J Nucl Cardiol. 2013 Aug;20(4):578-91. doi: 10.1007/s12350-013-9721-3. Epub 2013 May 9. Erratum In: J Nucl Cardiol. 2013 Aug;20(4):702. — View Citation
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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