Coronary Artery DiseaseEVAPERFNCT02208765
Prognostic Value of SPECT-imaging Myocardial Perfusion Heterogeneity
A study testing Stress Single Photon Emission Computed Tomography in people with Coronary Artery Disease and Coronary Atherosclerosis, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Endothelial dysfunction has been demonstrated to be an early marker of coronary artery disease (CAD). On the other hand, myocardial perfusion single photon emission computed tomography (MP-SPECT) is a widely used technique for evaluation of patients with suspected or known CAD. 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?
- Stress Single Photon Emission Computed Tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Jun 2022
- Phase
- Interventional
- 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
Who may be able to join
- Age > 18 years
- Clinical indication for myocardial perfusion imaging
Who cannot join
- Pregnancy
- Breast feeding women
- Severe comorbidity with life expectancy 6 months
- Left bundle branch block on ECG making heteogeneity analysis impossible
- Patient not resident in the Rhône-Alpes region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Value of Myocardial Perfusion Heterogeneity Assessed by Stress Single Photon Emission Computed Tomography
Endothelial dysfunction has been demonstrated to be an early marker of coronary artery disease (CAD). On the other hand, myocardial perfusion single photon emission computed tomography (MP-SPECT) is a widely used technique for evaluation of patients with suspected or known 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.
Read more
More over, factual data demonstrate that inhalation of particulate matters and gaz (NO2, CO) from air pollution contributes to the development of cardiovascular diseases in the short and long term. The role of air pollution in endothelial dysfunction has been suggested.
Accordingly, the purpose of this study is to evaluate the prognostic value of myocardial perfusion heterogeneity assessed by a new automatized image processing method applied to routine MP-SPECT.
The second purpose is to evaluate the role of air pollution exposure in pathogenesis of cardiovascular disease.
The main hypothesis is that the presence of myocardial perfusion heterogeneity is predictive of 2-year cardiovascular events in patients referred to the Nuclear Cardiology Department for routine evaluation of known or suspected CAD.
The second hypothesis is that microcirculatory coronary dysfunction is a causal link between air pollution and cardiovascular disease.
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.
- Air pollution exposure (particule matters and gaz) is estimated by SIRANE dispersion models validated by Air Rhône-Alpes, our regional agency tasked with protecting and managing the ambient air quality. The dispersion models are used to estimate the downwind ambient concentration of air pollutants or toxins emitted from sources such as industrial plants, vehicular traffic or accidental chemical releases.
Air pollution is estimated for each patient thanks to their postal private and professional adresses for different windows of exposure :
- short term windows (2hours to 7 days before the MP-SPECT and cardiovascular events).
- long term windows (1 - 5 years before the MP-SPECT and before cardiovascular events)
- Conditions
- Coronary Artery Disease, Coronary Atherosclerosis
- Being tested
- Stress Single Photon Emission Computed Tomography
- Keywords
- Coronary Circulation, Coronary Artery Disease, Myocardial perfusion imaging, Prognosis
- 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.
Stress Single Photon Emission Computed TomographyDevice
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | Other | Any 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 Receives: Device: Stress Single Photon Emission Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac and Cerebrovascular Events (MACCEs)
Composite outcome : cardiac death and/or acute coronary syndrome and/or coronary artery bypass graft and/or percutaneous coronary intervention and/or stroke and/or symptomatic peripheral artery disease
Measured: 2 years
Secondary outcomes (15)
composite secondary outcome : number of cardiac death or nonfatal Myocardial Infarction
Measured: 2 years
composite secondary outcome : number of cardiac death or nonfatal Myocardial Infarction or stroke
Measured: 2 years
composite secondary outcome : number of participants with myocardial revascularization
Measured: 2 years
composite secondary outcome : number of all death or non fatal Myocardial Infarction
Measured: 2 years
composite secondary outcome : number of all death or non fatal Myocardial Infarction or non fatal stroke
Measured: 2 years
composite secondary outcome : number of all death or non fatal Myocardial Infarction or non fatal stroke or number of participants with myocardial revascularization
Measured: 2 years
composite secondary outcome : number of all death or non fatal Myocardial Infarction or non fatal stroke or number of participants with myocardial revascularization or symptomatic peripheral artery disease
peripheral artery disease (intermittent claudication/new episode of critical limb ischaemia, new percutaneous/surgical revascularization, or amputation).
Measured: 2 years
cardiac death
Death from coronary artery disease, heart failure, or sudden death
Measured: 2 years
Non fatal Myocardial Infarction
Measured: 2 years
acute coronary syndrome
Measured: 2 years
Non fatal Stroke
Measured: 2 years
Coronary artery bypass graft and/or percutaneous coronary intervention
Measured: 2 years
14 Symptomatic peripheral artery disease (intermittent claudication/new episode of critical limb ischaemia, new percutaneous/surgical revascularization, or amputation)
Measured: 2 years
influence of air pollution exposure for short and long terms of exposure on myocardial Heterogeneity Index
Air pollution is estimated for each patient thanks to their postal private and professional adresses for different windows of exposure :
- short term windows (2hours to 7 days before the MP-SPECT and cardiovascular events).
- long term windows (1 - 5 years before the MP-SPECT and before cardiovascular events)
Measured: inclusion
influence of air pollution exposure for short and long terms of exposure on cardiovascular events
Air pollution is estimated for each patient thanks to their postal private and professional adresses for different windows of exposure :
- short term windows (2hours to 7 days before the MP-SPECT and cardiovascular events).
- long term windows (1 - 5 years before the MP-SPECT and before cardiovascular events)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerald Vanzetto, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208765
- Sponsor's protocol ID
- 38RC13.723
- Acronym
- EVAPERF
- Status last verified
- May 2022
- First submitted
- 4 Aug 2014
- Last updated
- 19 May 2022
- 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 15862426Vanzetto G, Ormezzano O, Fagret D, Comet M, Denis B, Machecourt J. Long-term additive prognostic value of thallium-201 myocardial perfusion imaging over clinical and exercise stress test in low to intermediate risk patients : study in 1137 patients with 6-year follow-up. Circulation. 1999 Oct 5;100(14):1521-7. doi: 10.1161/01.cir.100.14.1521.
PubMed 10510055Johnson 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 16157524
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Myocardial Perfusion Heterogeneity Assessed by Stress Single Photon Emission Computed Tomography
- ClinicalTrials.gov ID
- NCT02208765
- Acronym / sponsor ID
- EVAPERF / 38RC13.723
- Conditions
- Coronary Artery Disease, Coronary Atherosclerosis
- Keywords
- Coronary Circulation, Coronary Artery Disease, Myocardial perfusion imaging, Prognosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 5 Aug 2014 (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.
Endothelial dysfunction has been demonstrated to be an early marker of coronary artery disease (CAD). On the other hand, myocardial perfusion single photon emission computed tomography (MP-SPECT) is a widely used technique for evaluation of patients with suspected or known 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.
More over, factual data demonstrate that inhalation of particulate matters and gaz (NO2, CO) from air pollution contributes to the development of cardiovascular diseases in the short and long term. The role of air pollution in endothelial dysfunction has been suggested.
Accordingly, the purpose of this study is to evaluate the prognostic value of myocardial perfusion heterogeneity assessed by a new automatized image processing method applied to routine MP-SPECT.
The second purpose is to evaluate the role of air pollution exposure in pathogenesis of cardiovascular disease.
The main hypothesis is that the presence of myocardial perfusion heterogeneity is predictive of 2-year cardiovascular events in patients referred to the Nuclear Cardiology Department for routine evaluation of known or suspected CAD.
The second hypothesis is that microcirculatory coronary dysfunction is a causal link between air pollution and cardiovascular disease.
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.
- Air pollution exposure (particule matters and gaz) is estimated by SIRANE dispersion models validated by Air Rhône-Alpes, our regional agency tasked with protecting and managing the ambient air quality. The dispersion models are used to estimate the downwind ambient concentration of air pollutants or toxins emitted from sources such as industrial plants, vehicular traffic or accidental chemical releases.
Air pollution is estimated for each patient thanks to their postal private and professional adresses for different windows of exposure :
- short term windows (2hours to 7 days before the MP-SPECT and cardiovascular events).
- long term windows (1 - 5 years before the MP-SPECT and before cardiovascular events)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | Other | Device: Stress Single Photon Emission Computed TomographyAny 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Clinical indication for myocardial perfusion imaging
Key exclusion criteria (5 listed)
- Pregnancy
- Breast feeding women
- Severe comorbidity with life expectancy 6 months
- Left bundle branch block on ECG making heteogeneity analysis impossible
- Patient not resident in the Rhône-Alpes region
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 |
|---|---|---|
| Stress Single Photon Emission Computed Tomography | Device | Study cohort |
Primary outcome
Major Adverse Cardiac and Cerebrovascular Events (MACCEs)
Time frame: 2 years
Composite outcome : cardiac death and/or acute coronary syndrome and/or coronary artery bypass graft and/or percutaneous coronary intervention and/or stroke and/or symptomatic peripheral artery disease
15 secondary outcomes
composite secondary outcome : number of cardiac death or nonfatal Myocardial Infarction
Time frame: 2 years
composite secondary outcome : number of cardiac death or nonfatal Myocardial Infarction or stroke
Time frame: 2 years
composite secondary outcome : number of participants with myocardial revascularization
Time frame: 2 years
composite secondary outcome : number of all death or non fatal Myocardial Infarction
Time frame: 2 years
composite secondary outcome : number of all death or non fatal Myocardial Infarction or non fatal stroke
Time frame: 2 years
composite secondary outcome : number of all death or non fatal Myocardial Infarction or non fatal stroke or number of participants with myocardial revascularization
Time frame: 2 years
composite secondary outcome : number of all death or non fatal Myocardial Infarction or non fatal stroke or number of participants with myocardial revascularization or symptomatic peripheral artery disease
Time frame: 2 years
cardiac death
Time frame: 2 years
Non fatal Myocardial Infarction
Time frame: 2 years
acute coronary syndrome
Time frame: 2 years
Non fatal Stroke
Time frame: 2 years
Coronary artery bypass graft and/or percutaneous coronary intervention
Time frame: 2 years
14 Symptomatic peripheral artery disease (intermittent claudication/new episode of critical limb ischaemia, new percutaneous/surgical revascularization, or amputation)
Time frame: 2 years
influence of air pollution exposure for short and long terms of exposure on myocardial Heterogeneity Index
Time frame: inclusion
influence of air pollution exposure for short and long terms of exposure on cardiovascular events
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- 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 10510055Vanzetto G, Ormezzano O, Fagret D, Comet M, Denis B, Machecourt J. Long-term additive prognostic value of thallium-201 myocardial perfusion imaging over clinical and exercise stress test in low to intermediate risk patients : study in 1137 patients with 6-year follow-up. Circulation. 1999 Oct 5;100(14):1521-7. doi: 10.1161/01.cir.100.14.1521.
- 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.
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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.
Gerald Vanzetto, MD, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Single Photon Emission Computed Tomography in people with 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 5 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 19 May 2022. 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?
Results are not available in the source record.
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?
Major Adverse Cardiac and Cerebrovascular Events (MACCEs) (time frame: 2 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 NCT02208765, which also lists 4 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 19 May 2022.