Coronary Artery DiseasePROMETHENCT02576704
Prognostic Value of Myocardial Perfusion Heterogeneity in Normal SPECT Studies
An observational study of Coronary Artery Disease and Coronary Atherosclerosis, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Myocardial perfusion imaging is an efficient tool to assess the risk of major cardiac events for patients with known or suspected coronary artery disease. If the test is normal, or if the abnormalities of perfusion represent less than 10% of the left ventricle myocardium, the patient is considered at low risk and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Atherosclerosis
- What is being tested?
- semi conductor gamma camera
- Type of treatment
- Medical device
- How many people
- 1,119 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to Oct 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study cohort Patient referred to the Nuclear Cardiology Laboratory of the University Hospital of Grenoble for myocardial perfusion imaging for diagnosis or prognosis evaluation of suspected or know coronary artery disease, whose myocardial stress imaging was normal or with Summed stress score (SSS) < or = 4.
Who may be able to join
- Age > 18 years
- Clinical indication for myocardial perfusion imaging
Who cannot join
- Pregnancy
- Breastfeeding women
- Myocardial perfusion abnormalities with SSS > 4
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Value of Myocardial Perfusion Heterogeneity in Normal Dual Isotope High Speed Myocardial Perfusion Imaging With a Semi Conductor Gamma Camera.
Myocardial perfusion imaging is an efficient tool to assess the risk of major cardiac events for patients with known or suspected coronary artery disease. If the test is normal, or if the abnormalities of perfusion represent less than 10% of the left ventricle myocardium, the patient is considered at low risk and should be managed with optimal medical treatment only.
Recently, new gamma cameras using semi-conductor detectors have been developed. Their diagnostic performances have been demonstrated and confronted with various anatomical and functional reference techniques, such as coronary angiography and FFR. The prognostic value of a normal SPECT MPI has not been specifically assessed yet.
Read more
Coronary microvascular dysfunction (CMVD) has been demonstrated to be an early marker of coronary artery disease (CAD). Preliminary data suggest that myocardial perfusion heterogeneity (a potential surrogate marker of endothelial dysfunction) can be assessed on conventional MP-SPECT, but its additive and independent prognostic value over the presence of myocardial ischemia remain unknown.
Accordingly, the purpose of this study is :
- To assess the prognostic value of a normal myocardial perfusion stress imaging using a semiconductor gamma camera with a dual isotope high speed protocol,
- To evaluate the prognostic value of myocardial perfusion heterogeneity assessed by a new automatized image processing method, in normal SPECT MPIs.
The main hypothesis is that the presence of myocardial perfusion heterogeneity is predictive of cardiovascular events in patients referred to the Nuclear Cardiology Department for routine evaluation of known or suspected CAD.
Read the detailed description
SPECT imaging protocol and analysis Stress tests and SPECTs are performed according to the routine protocols in use in our center. Briefly, at peak stress, patients were injected with thallium-201. Five to 10 minutes after stress, a 5-minutes supine acquisition was performed followed by a 5-minutes prone acquisition. Subsequently, technetium-99m-sestamibi was injected, and 2 minutes later a single 5-minutes rest acquisition was performed. During stress acquisition, patients were imaged in supine and prone positions with their arms positioned over their head. The rest acquisition was only acquired in supine position. The gated SPECT studies were performed at each acquisition. Injected activity (IA) was adjusted for patient weight. For weights of <80 kg/ 80-100 kg/>100 kg, thallium-201 IAs were 74/92/111 MBq and technetium-99m-sestamibi IAs were 300/370/450 MBq, respectively. A uniform imaging pre-treatment for the reconstruction of raw myocardial perfusion imaging data was applied, and images were reconstructed and reoriented to obtain transaxial sections of the left ventricle according to the three standard cardiac planes.
In this study, we use a new mathematic technique from entropy analysis to provide precise, objective, automated quantification of perfusion heterogeneity at stress with camera SPECT. This method may be a non-invasive imaging to assess coronary microvascular dysfunction.
- Conditions
- Coronary Artery Disease, Coronary Atherosclerosis
- Being tested
- semi conductor gamma camera
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi conductor gamma cameraDevice
we use a new mathematic technique from entropy analysis to provide precise, objective, automated quantification of perfusion heterogeneity at stress with camera SPECT. This method may be a non-invasive imaging to assess coronary microvascular dysfunction.
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite primary outcome
number of cardiac death or nonfatal Myocardial Infarction
Measured: 3 years
Secondary outcomes (5)
first composite secondary outcome
number of cardiac death or nonfatal Myocardial Infarction or stroke
Measured: 3 years
secondary composite secondary outcome
number of cardiac death or nonfatal Myocardial Infarction or stroke or number of participants with myocardial revascularization
Measured: 3 years
third composite secondary outcome
number of all death or nonfatal Myocardial Infarction
Measured: 3 years
fourth composite secondary outcome
number of all death or nonfatal Myocardial Infarction or stroke
Measured: 3 years
fifth composite secondary outcome
number of all death or nonfatal Myocardial Infarction or stroke or number of participants with myocardial revascularization
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startMay 2011
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barone-Rochette Gilles, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576704
- Sponsor's protocol ID
- 2015-30
- Acronym
- PROMETHE
- Status last verified
- Jan 2017
- First submitted
- 13 Oct 2015
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Verma S, Buchanan MR, Anderson TJ. Endothelial function testing as a biomarker of vascular disease. Circulation. 2003 Oct 28;108(17):2054-9. doi: 10.1161/01.CIR.0000089191.72957.ED. No abstract available.
PubMed 14581384Schindler TH, Nitzsche EU, Schelbert HR, Olschewski M, Sayre J, Mix M, Brink I, Zhang XL, Kreissl M, Magosaki N, Just H, Solzbach U. Positron emission tomography-measured abnormal responses of myocardial blood flow to sympathetic stimulation are associated with the risk of developing cardiovascular events. J Am Coll Cardiol. 2005 May 3;45(9):1505-12. doi: 10.1016/j.jacc.2005.01.040.
PubMed 15862426Johnson NP, Gould KL. Clinical evaluation of a new concept: resting myocardial perfusion heterogeneity quantified by markovian analysis of PET identifies coronary microvascular dysfunction and early atherosclerosis in 1,034 subjects. J Nucl Med. 2005 Sep;46(9):1427-37.
PubMed 16157524Hachamovitch R, Hayes SW, Friedman JD, Cohen I, Berman DS. Comparison of the short-term survival benefit associated with revascularization compared with medical therapy in patients with no prior coronary artery disease undergoing stress myocardial perfusion single photon emission computed tomography. Circulation. 2003 Jun 17;107(23):2900-7. doi: 10.1161/01.CIR.0000072790.23090.41. Epub 2003 May 27.
PubMed 12771008Barone-Rochette G, Leclere M, Calizzano A, Vautrin E, Celine GC, Broisat A, Ghezzi C, Baguet JP, Machecourt J, Vanzetto G, Fagret D. Stress thallium-201/rest technetium-99m sequential dual-isotope high-speed myocardial perfusion imaging validation versus invasive coronary angiography. J Nucl Cardiol. 2015 Jun;22(3):513-22. doi: 10.1007/s12350-014-0016-0. Epub 2014 Nov 8.
PubMed 25381092
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Myocardial Perfusion Heterogeneity in Normal Dual Isotope High Speed Myocardial Perfusion Imaging With a Semi Conductor Gamma Camera.
- ClinicalTrials.gov ID
- NCT02576704
- Acronym / sponsor ID
- PROMETHE / 2015-30
- Conditions
- Coronary Artery Disease, Coronary Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,119 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 15 Oct 2015 (estimated)
- 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.
Myocardial perfusion imaging is an efficient tool to assess the risk of major cardiac events for patients with known or suspected coronary artery disease. If the test is normal, or if the abnormalities of perfusion represent less than 10% of the left ventricle myocardium, the patient is considered at low risk and should be managed with optimal medical treatment only.
Recently, new gamma cameras using semi-conductor detectors have been developed. Their diagnostic performances have been demonstrated and confronted with various anatomical and functional reference techniques, such as coronary angiography and FFR. The prognostic value of a normal SPECT MPI has not been specifically assessed yet.
Coronary microvascular dysfunction (CMVD) has been demonstrated to be an early marker of coronary artery disease (CAD). Preliminary data suggest that myocardial perfusion heterogeneity (a potential surrogate marker of endothelial dysfunction) can be assessed on conventional MP-SPECT, but its additive and independent prognostic value over the presence of myocardial ischemia remain unknown.
Accordingly, the purpose of this study is :
- To assess the prognostic value of a normal myocardial perfusion stress imaging using a semiconductor gamma camera with a dual isotope high speed protocol,
- To evaluate the prognostic value of myocardial perfusion heterogeneity assessed by a new automatized image processing method, in normal SPECT MPIs.
The main hypothesis is that the presence of myocardial perfusion heterogeneity is predictive of cardiovascular events in patients referred to the Nuclear Cardiology Department for routine evaluation of known or suspected CAD.
Detailed description
SPECT imaging protocol and analysis Stress tests and SPECTs are performed according to the routine protocols in use in our center. Briefly, at peak stress, patients were injected with thallium-201. Five to 10 minutes after stress, a 5-minutes supine acquisition was performed followed by a 5-minutes prone acquisition. Subsequently, technetium-99m-sestamibi was injected, and 2 minutes later a single 5-minutes rest acquisition was performed. During stress acquisition, patients were imaged in supine and prone positions with their arms positioned over their head. The rest acquisition was only acquired in supine position. The gated SPECT studies were performed at each acquisition. Injected activity (IA) was adjusted for patient weight. For weights of <80 kg/ 80-100 kg/>100 kg, thallium-201 IAs were 74/92/111 MBq and technetium-99m-sestamibi IAs were 300/370/450 MBq, respectively. A uniform imaging pre-treatment for the reconstruction of raw myocardial perfusion imaging data was applied, and images were reconstructed and reoriented to obtain transaxial sections of the left ventricle according to the three standard cardiac planes.
In this study, we use a new mathematic technique from entropy analysis to provide precise, objective, automated quantification of perfusion heterogeneity at stress with camera SPECT. This method may be a non-invasive imaging to assess coronary microvascular dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study cohort Patient referred to the Nuclear Cardiology Laboratory of the University Hospital of Grenoble for myocardial perfusion imaging for diagnosis or prognosis evaluation of suspected or know coronary artery disease, whose myocardial stress imaging was normal or with Summed stress score (SSS) < or = 4.
Key inclusion criteria (2 listed)
- Age > 18 years
- Clinical indication for myocardial perfusion imaging
Key exclusion criteria (3 listed)
- Pregnancy
- Breastfeeding women
- Myocardial perfusion abnormalities with SSS > 4
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 |
|---|---|---|
| semi conductor gamma camerawe use a new mathematic technique from entropy analysis to provide precise, objective, automated quantification of perfusion heterogeneity at stress with camera SPECT. This method may be a non-invasive imaging to assess coronary microvascular dysfunction. | Device | – |
Primary outcome
Composite primary outcome
Time frame: 3 years
number of cardiac death or nonfatal Myocardial Infarction
5 secondary outcomes
first composite secondary outcome
Time frame: 3 years
secondary composite secondary outcome
Time frame: 3 years
third composite secondary outcome
Time frame: 3 years
fourth composite secondary outcome
Time frame: 3 years
fifth composite secondary outcome
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Background: PubMed 14581384Verma S, Buchanan MR, Anderson TJ. Endothelial function testing as a biomarker of vascular disease. Circulation. 2003 Oct 28;108(17):2054-9. doi: 10.1161/01.CIR.0000089191.72957.ED. No abstract available.
- Background: PubMed 15862426Schindler TH, Nitzsche EU, Schelbert HR, Olschewski M, Sayre J, Mix M, Brink I, Zhang XL, Kreissl M, Magosaki N, Just H, Solzbach U. Positron emission tomography-measured abnormal responses of myocardial blood flow to sympathetic stimulation are associated with the risk of developing cardiovascular events. J Am Coll Cardiol. 2005 May 3;45(9):1505-12. doi: 10.1016/j.jacc.2005.01.040.
- Background: PubMed 16157524Johnson NP, Gould KL. Clinical evaluation of a new concept: resting myocardial perfusion heterogeneity quantified by markovian analysis of PET identifies coronary microvascular dysfunction and early atherosclerosis in 1,034 subjects. J Nucl Med. 2005 Sep;46(9):1427-37.
- Background: PubMed 12771008Hachamovitch R, Hayes SW, Friedman JD, Cohen I, Berman DS. Comparison of the short-term survival benefit associated with revascularization compared with medical therapy in patients with no prior coronary artery disease undergoing stress myocardial perfusion single photon emission computed tomography. Circulation. 2003 Jun 17;107(23):2900-7. doi: 10.1161/01.CIR.0000072790.23090.41. Epub 2003 May 27.
- Background: PubMed 25381092Barone-Rochette G, Leclere M, Calizzano A, Vautrin E, Celine GC, Broisat A, Ghezzi C, Baguet JP, Machecourt J, Vanzetto G, Fagret D. Stress thallium-201/rest technetium-99m sequential dual-isotope high-speed myocardial perfusion imaging validation versus invasive coronary angiography. J Nucl Cardiol. 2015 Jun;22(3):513-22. doi: 10.1007/s12350-014-0016-0. Epub 2014 Nov 8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Coronary Artery Disease and Coronary Atherosclerosis, run by University Hospital, Grenoble at 1 site in France.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 4 Jan 2017. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite primary outcome (time frame: 3 years). 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 NCT02576704, which also lists 5 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 4 Jan 2017.