Quantification of Myocardial Blood Flow by Positron Emission Tomography in Healthy Volunteers

Normal Healthy Volunteers Without Chronic Medical Conditions Clinical Trial

— PET Normals  

Official title:

Quantification of Myocardial Blood Flow by Positron Emission Tomography in Healthy Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03895554
• Other study ID #: STUDY00000188
• Status: Not yet recruiting
• Start date: April 1, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: March 2019
• Source: Ochsner Health System
• Contact: Robert M Bober, MD
• Phone: 5048426821
• Email: rbober[@]ochsner.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To establish quantitative values of myocardial blood flow (MBF) in normal, healthy volunteers .

Description:

We seek to establish quantitative values of myocardial blood flow in 20 normal, healthy volunteers using our existing 2D PET camera (Positron Attrius) and invasively validated software package (HeartSee) in order to 1) establish institutional values for which clinical patients can be compared to and 2) add to the collective data of the scientific community. Values to be measured will be resting myocardial blood flow (MBF), stress MBF and coronary flow reserve.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Adults =18 and <40 years old

• Participants must be able to give informed consent.

• Ability to abstain from caffeine for 48 hours

Exclusion Criteria:

• 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 coronary artery disease (history of myocardial infarctio, percutaneous intervention or coronary artery bypass grafting) in men <55 years old or women <65 years old

• Severe claustrophobia

• Positive urine pregnancy test

• Inability to give informed consent

Related Conditions & MeSH terms

• Normal Healthy Volunteers Without Chronic Medical Conditions

Intervention

Procedure:
• cardiac PET stress test
Volunteers will undergo cardiac PET stress testing

Locations

Country	Name	City	State
United States	Ochsner	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Ochsner Health System

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

Bergmann SR, Herrero P, Markham J, Weinheimer CJ, Walsh MN. Noninvasive quantitation of myocardial blood flow in human subjects with oxygen-15-labeled water and positron emission tomography. J Am Coll Cardiol. 1989 Sep;14(3):639-52. — View Citation

Gould KL, Johnson NP, Bateman TM, Beanlands RS, Bengel FM, Bober R, Camici PG, Cerqueira MD, Chow BJW, Di Carli MF, Dorbala S, Gewirtz H, Gropler RJ, Kaufmann PA, Knaapen P, Knuuti J, Merhige ME, Rentrop KP, Ruddy TD, Schelbert HR, Schindler TH, Schwaiger M, Sdringola S, Vitarello J, Williams KA Sr, Gordon D, Dilsizian V, Narula J. Anatomic versus physiologic assessment of coronary artery disease. Role of coronary flow reserve, fractional flow reserve, and positron emission tomography imaging in revascularization decision-making. J Am Coll Cardiol. 2013 Oct 29;62(18):1639-1653. doi: 10.1016/j.jacc.2013.07.076. Epub 2013 Aug 28. Review. — 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. — View Citation

Merlet P, Mazoyer B, Hittinger L, Valette H, Saal JP, Bendriem B, Crozatier B, Castaigne A, Syrota A, Randé 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

Nesterov SV, Deshayes E, Sciagrà R, Settimo L, Declerck JM, Pan XB, Yoshinaga K, Katoh C, Slomka PJ, Germano G, Han C, Aalto V, Alessio AM, Ficaro EP, Lee BC, Nekolla SG, Gwet KL, deKemp RA, Klein R, Dickson J, Case JA, Bateman T, Prior JO, Knuuti JM. Quantification of myocardial blood flow in absolute terms using (82)Rb PET imaging: the RUBY-10 Study. JACC Cardiovasc Imaging. 2014 Nov;7(11):1119-1127. doi: 10.1016/j.jcmg.2014.08.003. Epub 2014 Oct 8. — View Citation

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. — 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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute myocardial blood flow at rest and stress in cc/min/g	resting and stress MBF are in units of cc/min/g	measured at the time of the cardiac PET stress scan