Myocardial IschemiaRUBISNCT01679886
Comparison of Rubidium PET and SPECT With CZT Crystals for Detection of Myocardial Ischemia in Overweighed Patients and Women
A study testing Rubidium PET in people with Myocardial Ischemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- Rubidium PET
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 313 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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).
Who cannot join
- Pregnant women;
- Contraindication to dipyridamole injection.
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Bichat - Claude Bernard
Paris, Île-de-France Region, 75018
About this study
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).
Read the 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 < 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.
- Conditions
- Myocardial Ischemia
- Being tested
- Rubidium PET
- Keywords
- Position emission tomography;, Rubidium;, Women;, Overweighted patients
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rubidium PETRadiation
Rubidium PET
| Study group | Role | What they receive |
|---|---|---|
| Rubidium PET | Experimental | Rubidium PET Receives: Radiation: Rubidium PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial ischemia
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.
Measured: 1 year
Secondary outcomes (1)
Size and intensity of myocardial ischemia
- 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique LE GULUDEC, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679886
- Sponsor's protocol ID
- AOM 11066
- Acronym
- RUBIS
- Status last verified
- Jun 2016
- First submitted
- 3 Sep 2012
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40258438Mimouni 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.
PubMed 36752899
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01679886
- Acronym / sponsor ID
- RUBIS / AOM 11066
- Conditions
- Myocardial Ischemia
- Keywords
- Position emission tomography;, Rubidium;, Women;, Overweighted patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 < 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rubidium PET | Experimental | Radiation: Rubidium PETRubidium PET |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -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).
Key exclusion criteria (2 listed)
- Pregnant women;
- Contraindication to dipyridamole injection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rubidium PETRubidium PET | Radiation | Rubidium PET |
Primary outcome
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.
1 secondary outcome
Size and intensity of myocardial ischemia
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Derived from this study: PubMed 40258438Sprauel 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.
- Derived from this study: PubMed 36752899Mimouni 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique LE GULUDEC, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rubidium PET in people with Myocardial Ischemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial ischemia (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01679886, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.