Comparison Between Myocardial Tomoscintigraphies Using a Semiconductor Camera or a Conventional Camera
NCT ID: NCT02861235
Last Updated: 2016-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
276 participants
INTERVENTIONAL
2009-11-30
2010-05-31
Brief Summary
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This study will compare images recorded during 15 to 20 minutes by conventional cameras and 2 to 4 minutes by D.SPECT camera in patients doing tomoscintigraphy under usual conditions. The purpose is to demonstrate the equivalence of images recorded by two camera types for diagnostic information and the secondary purpose is to demonstrate the superiority of the D.SPECT camera in terms of image quality.
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Detailed Description
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Recording comparison obtained with 2 cameras will be done according to qualitative and quantitative criteria on image quality and analyzing diagnosis concordance (presence, type and severity of observed abnormalities).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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1. stress thallium-201 tomoscintigraphy
Stress thallium-201 tomoscintigraphy, followed by a second rest tomoscintigraphy if necessary
with gamma-camera and D.SPECT camera
2. stress technetium-99m tomoscintigraphy 1
Rest technetium-99m tomoscintigraphy followed by stress technetium-99m tomoscintigraphy on the same day
with gamma-camera and D.SPECT camera, in Toulouse centre
3. stress technetium-99m tomoscintigraphy 2
Stress technetium-99m tomoscintigraphy followed by rest technetium-99m tomoscintigraphy on the same day
with gamma-camera and D.SPECT camera, in Nancy centre
4. stress technetium-99m tomoscintigraphy 3
stress technetium-99m tomoscintigraphy followed by rest technetium-99m tomoscintigraphy in two different days
with gamma-camera and D.SPECT camera, in Paris centre
5. rest thallium-201 tomoscintigraphy
Rest thallium-201 tomoscintigraphy with gamma-camera and D.SPECT camera
rest thallium-201 tomoscintigraphy for myocardial viability assessment
6. rest technetium-99m tomoscintigraphy
Rest technetium-99m tomoscintigraphy with gamma-camera and D.SPECT camera
rest technetium-99m tomoscintigraphy for myocardial viability assessment
Interventions
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Stress thallium-201 tomoscintigraphy, followed by a second rest tomoscintigraphy if necessary
with gamma-camera and D.SPECT camera
Rest technetium-99m tomoscintigraphy followed by stress technetium-99m tomoscintigraphy on the same day
with gamma-camera and D.SPECT camera, in Toulouse centre
Stress technetium-99m tomoscintigraphy followed by rest technetium-99m tomoscintigraphy on the same day
with gamma-camera and D.SPECT camera, in Nancy centre
stress technetium-99m tomoscintigraphy followed by rest technetium-99m tomoscintigraphy in two different days
with gamma-camera and D.SPECT camera, in Paris centre
Rest thallium-201 tomoscintigraphy with gamma-camera and D.SPECT camera
rest thallium-201 tomoscintigraphy for myocardial viability assessment
Rest technetium-99m tomoscintigraphy with gamma-camera and D.SPECT camera
rest technetium-99m tomoscintigraphy for myocardial viability assessment
Eligibility Criteria
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Inclusion Criteria
* Without any contraindication for tomoscintigraphy and stress techniques according to French Society of Cardiology and Nuclear Medicine criteria, as established for all patients doing this routine examination
* Not in emergency situation and with a stable clinical status (without any sign of heart or coronary failure, without uncontrolled high blood pressure under treatment)
* Having an effective contraception for women of childbearing potential
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Principal Investigators
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Wassilia DJABALLAH
Role: PRINCIPAL_INVESTIGATOR
Service de Médecine Nucléaire, Hôpital de Brabois, 54500, Vandoeuvre-les-Nancy, France
Locations
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Service de Médecine Nucléaire, Hôpital de Bichat, Assistance Publique des Hôpitaux de Paris
Paris, , France
Service de Médecine Nucléaire, Clinique Louis Pasteur
Toulouse, , France
Service de Médecine Nucléaire, Hôpital de Brabois, CHU de Nancy
Vandœuvre-lès-Nancy, , France
Countries
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Other Identifiers
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2009-A00422-55
Identifier Type: -
Identifier Source: org_study_id
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