<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01679886</url>
  </required_header>
  <id_info>
    <org_study_id>AOM 11066</org_study_id>
    <nct_id>NCT01679886</nct_id>
  </id_info>
  <brief_title>Comparison of Rubidium PET and SPECT With CZT Crystals for Detection of Myocardial Ischemia in Overweighed Patients and Women</brief_title>
  <acronym>RUBIS</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of this study will be to compare the diagnostic performances of&#xD;
      82Rubidium-PET associated to pharmacologic stress (Persantine) to 99mTc-Sestamibi-SPECT with&#xD;
      CZT cameras associated to a stress test (exercise, pharmacological, mixed) for detection of&#xD;
      myocardial ischemia in a population of overweighed patients on one hand, and women on the&#xD;
      other hand, in a population with an intermediate prevalence of coronary artery disease (≥ 3&#xD;
      cardiovascular risk factors in asymptomatic patients or prevalence of CAD ≥ 30 % using the&#xD;
      DIAMOND-FORRESTER score in symptomatic patients).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective of this study will be to compare the diagnostic performances of&#xD;
      82Rubidium-PET associated to pharmacologic stress (Persantine) to 99mTc-Sestamibi-SPECT with&#xD;
      CZT cameras associated to a stress test (exercise, pharmacological, mixed) for detection of&#xD;
      myocardial ischemia in a population of overweighed patients on one hand, and women on the&#xD;
      other hand, in a population with an intermediate prevalence of coronary artery disease (≥ 3&#xD;
      cardiovascular risk factors in asymptomatic patients or prevalence of CAD ≥ 30 % using the&#xD;
      DIAMOND-FORRESTER score in symptomatic patients).&#xD;
&#xD;
      Secondary objectives. (1) Comparison between the size and intensity of myocardial ischemia&#xD;
      quantified using the sum difference score, left ventricular function at stress and at rest,&#xD;
      measured with 99mTc-Sestamibi-SPECT with CZT cameras and 82Rubidium-PET.&#xD;
&#xD;
      (2) Comparison between the values of coronary fractional flow reserve measured invasively and&#xD;
      noninvasively with 82Rubidium-PET in patients with stenosis ≥ 50 % on coronary angiography.&#xD;
&#xD;
      (3) Comparison of the effective dose caused by radiation exposure with 99mTc-Sestamibi-SPECT&#xD;
      with CZT cameras and 82Rubidium-PET.&#xD;
&#xD;
      (4) Comparison of the costs of the two diagnostic strategies in this population of patients.&#xD;
&#xD;
      Inclusion criteria: Overweighed (body mass index ≥ 25) or women addressed in the Department&#xD;
      of Nuclear Medicine for diagnostic cardiac scintigraphy with an intermediate pre-test&#xD;
      prevalence of CAD (≥ 3 cardiovascular risk factors in asymptomatic patients or prevalence of&#xD;
      CAD ≥ 30 % using the DIAMOND-FORRESTER score in symptomatic patients).&#xD;
&#xD;
      Non-inclusion criteria: Pregnant women; contraindication to dipyridamole injection.&#xD;
&#xD;
      Number of patients: 310 patients&#xD;
&#xD;
      Duration of the study. Duration of the study for a patient will be 16 months and 28 months&#xD;
      for the first patients. Total duration of the study will be 40 months, including an 24-month&#xD;
      inclusion time period.&#xD;
&#xD;
      Primary endpoint: Patients will be classified as positive in case of:&#xD;
&#xD;
        -  Myocardial ischemia defined as the presence of coronary stenosis ≥ 50 % on coronary&#xD;
           angiography with functional impairment of blood flow confirmed by invasive measurement&#xD;
           of coronary flow reserve (fractional flow reserve, FFR &lt; 0.8), or, in absence of&#xD;
           measurement of FFR, a critical coronary stenosis confirmed by the validation committee&#xD;
           of coronary angiographies.&#xD;
&#xD;
        -  In absence of coronary angiography, the presence of cardiovascular event (cardiovascular&#xD;
           or unknown cause of death, admission for acute coronary syndrome, unstable angina,&#xD;
           myocardial ischemia or coronary revascularization) validated by the endpoint&#xD;
           adjudication committee in the year following inclusion of the patient in the study.&#xD;
&#xD;
      Secondary endpoints: (1) Size and intensity of myocardial ischemia quantified using the sum&#xD;
      difference score and, left ventricular function at stress and at rest, measured with&#xD;
      99mTc-Sestamibi-SPECT with CZT cameras and 82Rubidium-PET. (2) Values of coronary fractional&#xD;
      flow reserve measured invasively and noninvasively with 82Rubidium-PET in patients with&#xD;
      stenosis ≥ 50 % on coronary angiography. (3) Effective dose caused by radiation exposure with&#xD;
      99mTc-Sestamibi-SPECT with CZT cameras and 82Rubidium-PET. (4) Costs of the two diagnostic&#xD;
      strategies in this population of patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Myocardial ischemia</measure>
    <time_frame>1 year</time_frame>
    <description>Patients will be classified as positive in case of:&#xD;
Coronary stenosis ≥ 50 % on coronary angiography and fractional flow reserve &lt; 0.8, or, in absence of FFR, a critical coronary stenosis.&#xD;
In absence of coronary angiography, presence of cardiovascular event during the following year.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Size and intensity of myocardial ischemia</measure>
    <time_frame>1 year</time_frame>
    <description>Size and intensity of myocardial ischemia quantified using the sum difference score,&#xD;
Left ventricular function at stress and at rest&#xD;
Values of FFR measured invasively and noninvasively&#xD;
Effective dose caused by radiation exposure&#xD;
Costs of the two diagnostic strategies</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">313</enrollment>
  <condition>Myocardial Ischemia</condition>
  <arm_group>
    <arm_group_label>Rubidium PET</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rubidium PET</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Rubidium PET</intervention_name>
    <description>Rubidium PET</description>
    <arm_group_label>Rubidium PET</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        INCLUSION CRITERIA :&#xD;
&#xD;
        -Overweighed (body mass index ≥ 25) or women addressed in the Department of Nuclear&#xD;
        Medicine for diagnostic cardiac scintigraphy with an intermediate pre-test prevalence of&#xD;
        CAD (≥ 3 cardiovascular risk factors in asymptomatic patients or prevalence of CAD ≥ 30 %&#xD;
        using the DIAMOND-FORRESTER score in symptomatic patients).&#xD;
&#xD;
        EXCLUSION CRITERIA :&#xD;
&#xD;
          -  Pregnant women;&#xD;
&#xD;
          -  Contraindication to dipyridamole injection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dominique LE GULUDEC, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Groupe Hospitalier Bichat - Claude Bernard</name>
      <address>
        <city>Paris</city>
        <state>Ile de France</state>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>September 3, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>February 20, 2017</last_update_submitted>
  <last_update_submitted_qc>February 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Position emission tomography;</keyword>
  <keyword>Rubidium;</keyword>
  <keyword>Women;</keyword>
  <keyword>Overweighted patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01679886
org study id: AOM 11066
nct id: NCT01679886
lead sponsor: 
has dmc: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Myocardial ischemia
time frame: 1 year
description: 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.
measure: Size and intensity of myocardial ischemia
time frame: 1 year
description: 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
arm group label: Rubidium PET
arm group type: Experimental
description: Rubidium PET
intervention type: Radiation
intervention name: Rubidium PET
description: Rubidium PET
arm group label: Rubidium PET
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dominique LE GULUDEC, MD, PhD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
responsible party type: Sponsor
mesh term: Myocardial Ischemia
mesh term: Coronary Artery Disease
mesh term: Ischemia
sharing ipd: Undecided