3D PET Myocardial Blood Flow and Rb82 Infusion Profiles

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05286593
• Other study ID #: STUDY00001584
• Status: Completed
• Phase: Phase 4
• Start date: December 28, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: January 2023
• Source: Ochsner Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cardiac Risk Factors
• Coronary Artery Disease
• Infarction
• Myocardial Infarction
• Normal Healthy Volunteers Without Chronic Medical Conditions

Intervention

Drug:
• Slow Infusion of Rubidium-82
Normal volunteers will receive weight based doses of Rb-82 infused as a slow infusion
• Slow Infusion of Rubidium-82
Clinical patients will receive weight based doses of Rb-82 infused as a slow infusion
• Slow Infusion of Rubidium-82
Infarct volunteers will receive weight based doses of Rb-82 infused as a slow infusion

Locations

Country	Name	City	State
United States	Ochsner	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Ochsner Health System	Bracco Corporate

Country where clinical trial is conducted

United States, 

References & Publications (13)

Araujo LI, Lammertsma AA, Rhodes CG, McFalls EO, Iida H, Rechavia E, Galassi A, De Silva R, Jones T, Maseri A. Noninvasive quantification of regional myocardial blood flow in coronary artery disease with oxygen-15-labeled carbon dioxide inhalation and positron emission tomography. Circulation. 1991 Mar;83(3):875-85. doi: 10.1161/01.cir.83.3.875. — View Citation

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. doi: 10.1161/01.cir.70.4.724. — View Citation

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. — View Citation

Gewirtz H, Fischman AJ, Abraham S, Gilson M, Strauss HW, Alpert NM. Positron emission tomographic measurements of absolute regional myocardial blood flow permits identification of nonviable myocardium in patients with chronic myocardial infarction. J Am Coll Cardiol. 1994 Mar 15;23(4):851-9. doi: 10.1016/0735-1097(94)90629-7. — View Citation

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

Kern MJ, Bach RG, Mechem CJ, Caracciolo EA, Aguirre FV, Miller LW, Donohue TJ. Variations in normal coronary vasodilatory reserve stratified by artery, gender, heart transplantation and coronary artery disease. J Am Coll Cardiol. 1996 Nov 1;28(5):1154-60. doi: 10.1016/S0735-1097(96)00327-0. — View Citation

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

Merlet P, Mazoyer B, Hittinger L, Valette H, Saal JP, Bendriem B, Crozatier B, Castaigne A, Syrota A, Rande JL. Assessment of coronary reserve in man: comparison between positron emission tomography with oxygen-15-labeled water and intracoronary Doppler technique. J Nucl Med. 1993 Nov;34(11):1899-904. — View Citation

Murthy VL, Bateman TM, Beanlands RS, Berman DS, Borges-Neto S, Chareonthaitawee P, Cerqueira MD, deKemp RA, DePuey EG, Dilsizian V, Dorbala S, Ficaro EP, Garcia EV, Gewirtz H, Heller GV, Lewin HC, Malhotra S, Mann A, Ruddy TD, Schindler TH, Schwartz RG, Slomka PJ, Soman P, Di Carli MF, Einstein A, Russell R, Corbett JR. Clinical Quantification of Myocardial Blood Flow Using PET: Joint Position Paper of the SNMMI Cardiovascular Council and the ASNC. J Nucl Cardiol. 2018 Feb;25(1):269-297. doi: 10.1007/s12350-017-1110-x. No abstract available. Erratum In: J Nucl Cardiol. 2018 Apr 10;: — View Citation

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

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. — View Citation

Rivas F, Cobb FR, Bache RJ, Greenfield JC Jr. Relationship between blood flow to ischemic regions and extent of myocardial infarction. Serial measurement of blood flow to ischemic regions in dogs. Circ Res. 1976 May;38(5):439-47. doi: 10.1161/01.res.38.5.439. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

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

External Links

•   Quantification of Resting Myocardial Blood Flow Using Rubidum82 Positron Emission Tomography in Regions with MRI-Confirmed Myocardial Scar. Annals of Nuclear Cardiology.