Comparison Between Myocardial Tomoscintigraphies Using a Semiconductor Camera or a Conventional Camera
- Conditions
- Myocardial InfarctionIschemia
- Registration Number
- NCT02861235
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 276
- Understanding and signature of informed consent
- 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
- Patient under guardianship
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Telesystolic volume of link ventricle day 0 Diagnosis of stress ischemia with Myocardial Tomoscintigraphy data day 0 Telediastolic volume of link ventricle day 0 Area of damaged regions of heart day 0 Ejection fraction of link ventricle day 0
- Secondary Outcome Measures
Name Time Method Qualitative score of image quality day 0 Global myocardial activity day 0
Trial Locations
- Locations (3)
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
🇫🇷Vandoeuvre-les-Nancy, France
Service de Médecine Nucléaire, Hôpital de Bichat, Assistance Publique des Hôpitaux de Paris🇫🇷Paris, France