Comparison of Rubidium PET and SPECT With CZT Crystals for Detection of Myocardial Ischemia in Overweighed Patients and Women (RUBIS)
Primary Purpose
Myocardial Ischemia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Rubidium PET
Sponsored by
About this trial
This is an interventional diagnostic trial for Myocardial Ischemia focused on measuring Position emission tomography;, Rubidium;, Women;, Overweighted patients
Eligibility Criteria
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.
Sites / Locations
- Groupe Hospitalier Bichat - Claude Bernard
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rubidium PET
Arm Description
Rubidium PET
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01679886
First Posted
September 3, 2012
Last Updated
February 20, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT01679886
Brief Title
Comparison of Rubidium PET and SPECT With CZT Crystals for Detection of Myocardial Ischemia in Overweighed Patients and Women
Acronym
RUBIS
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 Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia
Keywords
Position emission tomography;, Rubidium;, Women;, Overweighted patients
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
313 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rubidium PET
Arm Type
Experimental
Arm Description
Rubidium PET
Intervention Type
Radiation
Intervention Name(s)
Rubidium PET
Intervention Description
Rubidium PET
Primary Outcome Measure Information:
Title
Myocardial ischemia
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Size and intensity of myocardial ischemia
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
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique LE GULUDEC, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Bichat - Claude Bernard
City
Paris
State/Province
Ile de France
ZIP/Postal Code
75018
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparison of Rubidium PET and SPECT With CZT Crystals for Detection of Myocardial Ischemia in Overweighed Patients and Women
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