Myocardial Ischemia Clinical Trial
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
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).
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 < 0.8), 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.
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