Myocardial Infarction Clinical Trial
Official title:
Comparison Between Myocardial Tomoscintigraphies Using a Semiconductor Camera or a Conventional Camera According to Conditions of Examination Execution: Assessment of Infarction or Ischemia, Injected Dye and Sequence of Injections
Myocardial perfusion tomoscintigraphy is a routine medicine procedure to check for the
presence and severity of abnormalities of myocardial perfusion, as well as the extension of
infarction residua. However, actual imagery devices (gamma cameras) have low resolution and
detection sensitivity. A new semiconductor camera has 8 to 10 time higher detection
sensitivity and could allow proportionally diminishing injected activities or recording
times. Only one pilot study has been recently published on this type of camera, the D.SPECT
camera.
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.
This study will be conducted in Nuclear Medicine departments (Nancy Hospital, Bichat
Hospital in Paris, Pasteur private hospital in Toulouse), with D.SPECT camera (Cyclopharma).
The D.SPECT camera recording will be realized following the conventional camera recording
and will not modify the routine programmed examination. Recording times of D.SPECT camera
will be maximum 2 minutes for imaging with a strong activity of technetium-99m labeled dye
and maximum 4 minutes for imaging with thallium-201 or with a low activity of technetium-99m
labeled dye.6 study groups will be analyzed: 4 groups of patients initially doing stress
tomoscintigraphy with thallium-201 (group 1) or with technetium-99m labeled dye and then
testing 3 principal injection sequences (group 2, 3, 4), and 2 groups of patients initially
doing "myocardial viability" assessment with rest tomoscintigraphy with thallium-201 (group
5) or technetium-99m labeled dye.
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).
;
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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