Comparison of Rubidium PET and SPECT With CZT Crystals for Detection of Myocardial Ischemia in Overweighed Patients and Women (RUBIS)
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ClinicalTrials.gov Identifier: NCT01679886 |
Recruitment Status :
Completed
First Posted : September 6, 2012
Last Update Posted : February 23, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myocardial Ischemia | Radiation: Rubidium PET | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 313 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
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 |
Study Start Date : | September 2012 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | June 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Rubidium PET
Rubidium PET
|
Radiation: Rubidium PET
Rubidium PET |
- Myocardial ischemia [ Time Frame: 1 year ]
Patients will be classified as positive in case of:
- Coronary stenosis ≥ 50 % on coronary angiography and fractional flow reserve < 0.8, or, in absence of FFR, a critical coronary stenosis.
- In absence of coronary angiography, presence of cardiovascular event during the following year.
- Size and intensity of myocardial ischemia [ Time Frame: 1 year ]
- Size and intensity of myocardial ischemia quantified using the sum difference score,
- Left ventricular function at stress and at rest
- Values of FFR measured invasively and noninvasively
- Effective dose caused by radiation exposure
- Costs of the two diagnostic strategies

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 :
- Pregnant women;
- Contraindication to dipyridamole injection.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679886
France | |
Groupe Hospitalier Bichat - Claude Bernard | |
Paris, Ile de France, France, 75018 |
Principal Investigator: | Dominique LE GULUDEC, MD, PhD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT01679886 |
Other Study ID Numbers: |
AOM 11066 |
First Posted: | September 6, 2012 Key Record Dates |
Last Update Posted: | February 23, 2017 |
Last Verified: | June 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Position emission tomography; Rubidium; Women; Overweighted patients |
Myocardial Ischemia Coronary Artery Disease Ischemia Pathologic Processes Heart Diseases |
Cardiovascular Diseases Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases |