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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rubidium PET | Experimental | Rubidium PET |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rubidium PET | Radiation | Rubidium PET |
|
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial ischemia | Patients will be classified as positive in case of:
| 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Size and intensity of myocardial ischemia |
| 1 year |
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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).
EXCLUSION CRITERIA :
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| Name | Affiliation | Role |
|---|---|---|
| Dominique LE GULUDEC, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier Bichat - Claude Bernard | Paris | ÃŽle-de-France Region | 75018 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40258438 | Derived | Sprauel T, Imbert L, Doyeux K, Perrin M, Claudin M, Roch V, Doyen M, Roth N, Lamash Y, Chequer R, Rouzet F, Hyafil F, Marie PY. Assessment of sestamibi CZT-SPECT reconstructed using deep-learning-based virtual attenuation correction maps according to coronary artery territory and with comparison to rubidium-PET. J Nucl Cardiol. 2025 Jul;49:102226. doi: 10.1016/j.nuclcard.2025.102226. Epub 2025 Apr 19. | |
| 36752899 |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Derived |
| Mimouni M, Bulsei J, Darlington M, Estellat C, Rouzet F, Hyafil F, Durand-Zaleski I; RUBIS Trial Group. Cost-effectiveness of 82-Rubidium PET myocardial perfusion imaging for the diagnosis of myocardial ischemia depending on the prevalence of coronary artery disease. EJNMMI Res. 2023 Feb 8;13(1):9. doi: 10.1186/s13550-023-00954-x. |