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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01679886
First received: September 3, 2012
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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).


Condition Intervention
Myocardial Ischemia
Radiation: Rubidium PET

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Myocardial ischemia [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    1. Size and intensity of myocardial ischemia quantified using the sum difference score,
    2. Left ventricular function at stress and at rest
    3. Values of FFR measured invasively and noninvasively
    4. Effective dose caused by radiation exposure
    5. Costs of the two diagnostic strategies


Estimated Enrollment: 261
Study Start Date: September 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rubidium PET
Rubidium PET
Radiation: Rubidium PET
Rubidium PET
Other Name: 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: 261 patients

Duration of the study. Duration of the study for a patient will be 12 months. Total duration of the study will be 20 months, including an 8-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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679886

Contacts
Contact: Dominique LE GULUDEC, MD, PhD 01.40.25.84.10 ext + 33 dominique.leguludec@bch.aphp.fr
Contact: Fabien HYAFIL, MD 01,40,25,64,75 ext +33 fabien.hyafil@bch.aphp.fr

Locations
France
Groupe Hospitalier Bichat - Claude Bernard Recruiting
Paris, Ile de France, France, 75018
Contact: Dominique LE GULUDEC, MD, PhD    01.40.25.84.10 ext + 33    dominique.leguludec@bch.aphp.fr   
Contact: Fabien HYAFIL, MD    01.40.25.64.75 ext +33    fabien.hyafil@bch.aphp.fr   
Principal Investigator: Dominique LE GULUDEC, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Dominique LE GULUDEC, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01679886     History of Changes
Other Study ID Numbers: AOM 11066
Study First Received: September 3, 2012
Last Updated: August 13, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Position emission tomography;
Rubidium;
Women;
Overweighted patients

Additional relevant MeSH terms:
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on September 16, 2014