Normal Healthy Volunteers Without Chronic Medical ConditionsPET NormalsNCT03895554
Quantification of Myocardial Blood Flow by Positron Emission Tomography in Healthy Volunteers
An observational study of Normal Healthy Volunteers Without Chronic Medical Conditions, run by Ochsner Health System at 1 site in United States.
Trial summary
To establish quantitative values of myocardial blood flow (MBF) in normal, healthy volunteers . Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Healthy Volunteers Without Chronic Medical Conditions
- What is being tested?
- cardiac PET stress test
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Volunteers will be selected from the local community.
Who may be able to join
- Adults ≥18 and <40 years old
- Participants must be able to give informed consent.
- Ability to abstain from caffeine for 48 hours
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ochsner
New Orleans, Louisiana, 70120
Robert Bober, MD, 504-842-6821, rbober@ochsner.org
Hunter McDaniel, 504.703.3272, hunter.mcdaniel@ochsner.org
About this study
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.
- Being tested
- cardiac PET stress test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac PET stress testProcedure or surgery
Volunteers will undergo cardiac PET stress testing
| Study group | Role | What they receive |
|---|---|---|
| Normal volunteers | Normal, healthy volunteers with undergo cardiac PET stress testing. Receives: Procedure: cardiac PET stress test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute myocardial blood flow at rest and stress in cc/min/g
resting and stress MBF are in units of cc/min/g
Measured: measured at the time of the cardiac PET stress scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Normal Healthy Volunteers Without Chronic Medical ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Bober, M.D., Ochsner Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895554
- Sponsor's protocol ID
- STUDY00000188
- Acronym
- PET Normals
- Status last verified
- Mar 2019
- First submitted
- 27 Mar 2019
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Intention to publish the data in peer reviewed journal.
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 1900224Bergmann 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 2788669Sdringola 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 21492816Renaud 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 23657833Merlet 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 8229231Kern 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 8890809Renaud 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 27539843Gould 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 23954338Nesterov 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Myocardial Blood Flow by Positron Emission Tomography in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03895554
- Acronym / sponsor ID
- PET Normals / STUDY00000188
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 29 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To establish quantitative values of myocardial blood flow (MBF) in normal, healthy volunteers .
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal volunteers | – | Procedure: cardiac PET stress testNormal, healthy volunteers with undergo cardiac PET stress testing. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Volunteers will be selected from the local community.
Key inclusion criteria (3 listed)
- Adults ≥18 and <40 years old
- Participants must be able to give informed consent.
- Ability to abstain from caffeine for 48 hours
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac PET stress testVolunteers will undergo cardiac PET stress testing | Procedure or surgery | Normal volunteers |
Primary outcome
Absolute myocardial blood flow at rest and stress in cc/min/g
Time frame: measured at the time of the cardiac PET stress scan
resting and stress MBF are in units of cc/min/g
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Background: PubMed 1900224Araujo 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.
- Background: PubMed 2788669Bergmann 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.
- Background: PubMed 21492816Sdringola 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.
- Background: PubMed 23657833Renaud 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.
- Background: PubMed 8229231Merlet 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.
- Background: PubMed 8890809Kern 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.
- Background: PubMed 27539843Renaud 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.
- Background: PubMed 23954338Gould 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.
- Background: PubMed 25306543Nesterov 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.
- Individual participant dataSharing planned: Undecided. Intention to publish the data in peer reviewed journal.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Healthy Volunteers Without Chronic Medical Conditions, run by Ochsner Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert M Bober, MD (5048426821, rbober@ochsner.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute myocardial blood flow at rest and stress in cc/min/g (time frame: measured at the time of the cardiac PET stress scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03895554, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.