Comparison of Rubidium PET and SPECT With CZT Crystals for Detection of Myocardial Ischemia in Overweighed Patients and Women (RUBIS)

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).

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia
• Intervention / Treatment: Radiation: Rubidium PET

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 Type: Interventional
• Enrollment (Actual): 313
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile de France
    • Paris, Ile de France, France, 75018
      • Groupe Hospitalier Bichat - Claude Bernard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Rubidium PET	Radiation: Rubidium PET; Rubidium PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: September 3, 2012
• First Submitted That Met QC Criteria: September 3, 2012
• First Posted (ESTIMATE): September 6, 2012

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 20, 2017
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Position emission tomography;; Rubidium;; Women;; Overweighted patients
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: AOM 11066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED