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

NCT03895554 | Unknown

• 1 other identifier: STUDY00000188
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Normal Healthy Volunteers Without Chronic Medical Conditions

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Normal volunteers

Normal, healthy volunteers with undergo cardiac PET stress testing.

Procedure: cardiac PET stress test

Interventions

cardiac PET stress test PROCEDURE

Volunteers will undergo cardiac PET stress testing

Normal volunteers

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Volunteers will be selected from the local community.

You may qualify if:

• Adults ≥18 and \<40 years old
• Participants must be able to give informed consent.
• Ability to abstain from caffeine for 48 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Ochsner Health System: lead

Study Sites (1)

Ochsner

New Orleans, Louisiana, 70120, United States

Location

Related 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. doi: 10.1161/01.cir.83.3.875.

  PMID: 1900224 BACKGROUND

• 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. doi: 10.1016/0735-1097(89)90105-8.

  PMID: 2788669 BACKGROUND

• 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.

  PMID: 21492816 BACKGROUND

• 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.

  PMID: 23657833 BACKGROUND

• 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.

  PMID: 8229231 BACKGROUND

• 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.

  PMID: 8890809 BACKGROUND

• 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.

  PMID: 27539843 BACKGROUND

• 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.

  PMID: 23954338 BACKGROUND

• Nesterov SV, Deshayes E, Sciagra 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.

  PMID: 25306543 BACKGROUND

Central Study Contacts

Robert M Bober, MD

CONTACT

5048426821; rbober@ochsner.org

Hunter McDaniel

CONTACT

5047033272; hunter.mcdaniel@ochsner.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiac Molecular Imaging

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: March 29, 2019
• Study Start: April 1, 2019
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: March 29, 2019

Record last verified: 2019-03

Locations

US (1)