3D PET Myocardial Blood Flow and Rb82 Infusion Profiles
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
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:
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Healthy volunteers
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Clinical volunteers with risk factors and/or CAD
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Volunteers with clinical infarcts.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: Normal volunteers 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
Normal volunteers will receive weight based doses of Rb-82 infused as a slow infusion
Other Names:
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Other: Clinical patients 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
Clinical patients will receive weight based doses of Rb-82 infused as a slow infusion
Other Names:
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Other: Infarcts 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
Infarct volunteers will receive weight based doses of Rb-82 infused as a slow infusion
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
Normal Volunteers
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Adults ≥18 and <40 years old able to give informed consent.
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Ability to abstain from caffeine for 48 hours
The "clinical" population
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Adults ≥18 years old able to give informed consent.
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Any cardiac risk factor including hypertension, hyperlipidemia, diabetes mellitus or tobacco use OR
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CAD defined by with history of PCI or CABG, Coronary Ca score>400, or dense coronary calcifications noted on chest CT
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Ability to abstain from caffeine for 48 hours
The "infarct" population
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Adults ≥18 years old able to give informed consent.
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Prior cardiac PET scan demonstrating a fixed defect ≥ 15% of the LV myocardium with relative uptake ≤60% maximum uptake.
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In addition, to the perfusion defect, each volunteer requires either:
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FDG PET or MRI viability studies confirming infarct OR
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akinesis and wall thinning on ECHO within the same territory as the PET defect in addition to Q-waves on ECG
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Ability to abstain from caffeine for 48 hours
Exclusion Criteria:
Normal Volunteers
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Any chronic cardiac disease or condition (e.g., hypertension, hyperlipidemia)
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Any chronic systemic disease or condition (e.g., diabetes, systemic lupus, rheumatoid arthritis)
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Tobacco use
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Family history in a first degree relative with clinical CAD (h/o PCI, MI or CABG) in men <55 or women <65
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Severe claustrophobia
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Positive urine pregnancy test
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Inability to give informed consent
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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
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Severe claustrophobia
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Hemodynamic instability or unstable symptoms
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Positive urine pregnancy test
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Inability to give informed consent
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Ochsner | New Orleans | Louisiana | United States | 70120 |
Sponsors and Collaborators
- Ochsner Health System
- Bracco Corporate
Investigators
None specified.Study Documents (Full-Text)
More Information
Additional Information:
Publications
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- Bergmann SR, Fox KA, Rand AL, McElvany KD, Welch MJ, Markham J, Sobel BE. Quantification of regional myocardial blood flow in vivo with H215O. Circulation. 1984 Oct;70(4):724-33.
- Bui L, Kitkungvan D, Roby AE, Nguyen TT, Gould KL. Pitfalls in quantitative myocardial PET perfusion II: Arterial input function. J Nucl Cardiol. 2020 Apr;27(2):397-409. doi: 10.1007/s12350-020-02074-8. Epub 2020 Mar 3.
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- Renaud JM, DaSilva JN, Beanlands RS, DeKemp RA. Characterizing the normal range of myocardial blood flow with ⁸²rubidium and ¹³N-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.
- Renaud JM, Yip K, Guimond J, Trottier M, Pibarot P, Turcotte E, Maguire C, Lalonde L, Gulenchyn K, Farncombe T, Wisenberg G, Moody J, Lee B, Port SC, Turkington TG, Beanlands RS, deKemp RA. Characterization of 3-Dimensional PET Systems for Accurate Quantification of Myocardial Blood Flow. J Nucl Med. 2017 Jan;58(1):103-109. doi: 10.2967/jnumed.116.174565. Epub 2016 Aug 18.
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- Sdringola S, Johnson NP, Kirkeeide RL, Cid E, Gould KL. Impact of unexpected factors on quantitative myocardial perfusion and coronary flow reserve in young, asymptomatic volunteers. JACC Cardiovasc Imaging. 2011 Apr;4(4):402-12. doi: 10.1016/j.jcmg.2011.02.008.
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