Ignite Creation Date:
2024-05-06 @ 3:06 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02208765
Status:
UNKNOWN
Last Update Posted:
2022-05-19
First Post:
2014-08-04
Brief Title:
Prognostic Value of SPECT-imaging Myocardial Perfusion Heterogeneity
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Prognostic Value of Myocardial Perfusion Heterogeneity Assessed by Stress Single Photon Emission Computed Tomography
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVAPERF
Brief 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
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
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:
1 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 kg100 kg thallium-201 IAs were 7492111 MBq and technetium-99m-sestamibi IAs were 300370450 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
2 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
3 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
2 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
3 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None