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Status unknownNCT03895554PET NormalsUpdated Mar 29, 2019

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

An observational study in Normal Healthy Volunteers Without Chronic Medical Conditions, sponsored by Ochsner Health System. Status unknown at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-29.

Sponsored by Ochsner Health System · Observational

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 40 Years
Sex
All
01

Study summary

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

Read the detailed 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.

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Conditions studied

  • Normal Healthy Volunteers Without Chronic Medical Conditions
03

In context

Lead sponsor

Ochsner Health System is the lead sponsor of 57 studies on the registry; 7 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Volunteers will be selected from the local community.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • Normal volunteers

    Normal, healthy volunteers with undergo cardiac PET stress testing.

    Procedure: cardiac PET stress test

Interventions

  • Procedurecardiac PET stress test

    Volunteers will undergo cardiac PET stress testing

06

What researchers measure

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

    Time frame: measured at the time of the cardiac PET stress scan

07

Study locations

1 site
  • Ochsner
    New Orleans, Louisiana 70120, United States
    • Robert Bober, MD · Contactrbober@ochsner.org · 504-842-6821
    • Hunter McDaniel · Contacthunter.mcdaniel@ochsner.org · 504.703.3272
    • Robert Bober, MD · Principal investigator
    • Nichole Polin, MD · Sub investigator
    • Merrill Stewart, MD · Sub investigator
    • Joseph Englert, MD · Sub investigator
08

References and documents

Publications

  • 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. PubMed 1900224 ↗
  • 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. PubMed 2788669 ↗
  • 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. PubMed 21492816 ↗
  • 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. PubMed 23657833 ↗
  • 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. PubMed 8229231 ↗
  • 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. PubMed 8890809 ↗
  • 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. PubMed 27539843 ↗
  • 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. PubMed 23954338 ↗
  • 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. PubMed 25306543 ↗

Individual participant data

Plan to share: Undecided — Intention to publish the data in peer reviewed journal.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03895554
Lead sponsor
Ochsner Health System
Responsible party
Robert Bober, M.D. (Director of Cardiac Molecular Imaging, Ochsner Health System) — Principal investigator
First posted
Mar 29, 2019
Start date
Apr 1, 2019 (estimated)
Primary completion
Sep 30, 2019 (estimated)
Completion
Sep 30, 2019 (estimated)
Last update
Mar 29, 2019

Study contacts

Robert M Bober, MD
Contact
rbober@ochsner.org
5048426821
Hunter McDaniel
Contact
hunter.mcdaniel@ochsner.org
5047033272

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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