Ignite Creation Date:
2024-05-06 @ 12:51 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01679886
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2012-09-03
Brief Title:
Comparison of Rubidium PET and SPECT With CZT Crystals for Detection of Myocardial Ischemia in Overweighed Patients and Women
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Comparison of the Diagnostic Performances of 82Rubidium Positron Emission Tomography and Conventional Scintigraphy With CZT Cameras for Detection of Myocardial Ischemia in a Population of Overweighed Patients and Women
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
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:
RUBIS
Brief Summary:
The main objective of this study will be to compare the diagnostic performances of 82Rubidium-PET associated to pharmacologic stress Persantine to 99mTc-Sestamibi-SPECT with CZT cameras associated to a stress test exercise pharmacological mixed for detection of myocardial ischemia in a population of overweighed patients on one hand and women on the other hand in a population with an intermediate prevalence of coronary artery disease 3 cardiovascular risk factors in asymptomatic patients or prevalence of CAD 30 using the DIAMOND-FORRESTER score in symptomatic patients
Detailed Description:
The main objective of this study will be to compare the diagnostic performances of 82Rubidium-PET associated to pharmacologic stress Persantine to 99mTc-Sestamibi-SPECT with CZT cameras associated to a stress test exercise pharmacological mixed for detection of myocardial ischemia in a population of overweighed patients on one hand and women on the other hand in a population with an intermediate prevalence of coronary artery disease 3 cardiovascular risk factors in asymptomatic patients or prevalence of CAD 30 using the DIAMOND-FORRESTER score in symptomatic patients
Secondary objectives 1 Comparison between the size and intensity of myocardial ischemia quantified using the sum difference score left ventricular function at stress and at rest measured with 99mTc-Sestamibi-SPECT with CZT cameras and 82Rubidium-PET
2 Comparison between the values of coronary fractional flow reserve measured invasively and noninvasively with 82Rubidium-PET in patients with stenosis 50 on coronary angiography
3 Comparison of the effective dose caused by radiation exposure with 99mTc-Sestamibi-SPECT with CZT cameras and 82Rubidium-PET
4 Comparison of the costs of the two diagnostic strategies in this population of patients
Inclusion criteria Overweighed body mass index 25 or women addressed in the Department of Nuclear Medicine for diagnostic cardiac scintigraphy with an intermediate pre-test prevalence of CAD 3 cardiovascular risk factors in asymptomatic patients or prevalence of CAD 30 using the DIAMOND-FORRESTER score in symptomatic patients
Non-inclusion criteria Pregnant women contraindication to dipyridamole injection
Number of patients 310 patients
Duration of the study Duration of the study for a patient will be 16 months and 28 months for the first patients Total duration of the study will be 40 months including an 24-month inclusion time period
Primary endpoint Patients will be classified as positive in case of
Myocardial ischemia defined as the presence of coronary stenosis 50 on coronary angiography with functional impairment of blood flow confirmed by invasive measurement of coronary flow reserve fractional flow reserve FFR 08 or in absence of measurement of FFR a critical coronary stenosis confirmed by the validation committee of coronary angiographies
In absence of coronary angiography the presence of cardiovascular event cardiovascular or unknown cause of death admission for acute coronary syndrome unstable angina myocardial ischemia or coronary revascularization validated by the endpoint adjudication committee in the year following inclusion of the patient in the study
Secondary endpoints 1 Size and intensity of myocardial ischemia quantified using the sum difference score and left ventricular function at stress and at rest measured with 99mTc-Sestamibi-SPECT with CZT cameras and 82Rubidium-PET 2 Values of coronary fractional flow reserve measured invasively and noninvasively with 82Rubidium-PET in patients with stenosis 50 on coronary angiography 3 Effective dose caused by radiation exposure with 99mTc-Sestamibi-SPECT with CZT cameras and 82Rubidium-PET 4 Costs of the two diagnostic strategies in this population of patients
Secondary objectives 1 Comparison between the size and intensity of myocardial ischemia quantified using the sum difference score left ventricular function at stress and at rest measured with 99mTc-Sestamibi-SPECT with CZT cameras and 82Rubidium-PET
2 Comparison between the values of coronary fractional flow reserve measured invasively and noninvasively with 82Rubidium-PET in patients with stenosis 50 on coronary angiography
3 Comparison of the effective dose caused by radiation exposure with 99mTc-Sestamibi-SPECT with CZT cameras and 82Rubidium-PET
4 Comparison of the costs of the two diagnostic strategies in this population of patients
Inclusion criteria Overweighed body mass index 25 or women addressed in the Department of Nuclear Medicine for diagnostic cardiac scintigraphy with an intermediate pre-test prevalence of CAD 3 cardiovascular risk factors in asymptomatic patients or prevalence of CAD 30 using the DIAMOND-FORRESTER score in symptomatic patients
Non-inclusion criteria Pregnant women contraindication to dipyridamole injection
Number of patients 310 patients
Duration of the study Duration of the study for a patient will be 16 months and 28 months for the first patients Total duration of the study will be 40 months including an 24-month inclusion time period
Primary endpoint Patients will be classified as positive in case of
Myocardial ischemia defined as the presence of coronary stenosis 50 on coronary angiography with functional impairment of blood flow confirmed by invasive measurement of coronary flow reserve fractional flow reserve FFR 08 or in absence of measurement of FFR a critical coronary stenosis confirmed by the validation committee of coronary angiographies
In absence of coronary angiography the presence of cardiovascular event cardiovascular or unknown cause of death admission for acute coronary syndrome unstable angina myocardial ischemia or coronary revascularization validated by the endpoint adjudication committee in the year following inclusion of the patient in the study
Secondary endpoints 1 Size and intensity of myocardial ischemia quantified using the sum difference score and left ventricular function at stress and at rest measured with 99mTc-Sestamibi-SPECT with CZT cameras and 82Rubidium-PET 2 Values of coronary fractional flow reserve measured invasively and noninvasively with 82Rubidium-PET in patients with stenosis 50 on coronary angiography 3 Effective dose caused by radiation exposure with 99mTc-Sestamibi-SPECT with CZT cameras and 82Rubidium-PET 4 Costs of the two diagnostic strategies in this population of patients
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