Clinical trial NCT02861235: Comparison Between Myocardial Tomoscintigraphies Using a Semiconductor Camera or a Conventional Camera
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Ischemia
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patient under guardianship

Primary outcomes:
measure: Ejection fraction of link ventricle
timeFrame: day 0
measure: Telesystolic volume of link ventricle
timeFrame: day 0
measure: Telediastolic volume of link ventricle
timeFrame: day 0
measure: Diagnosis of stress ischemia with Myocardial Tomoscintigraphy data
timeFrame: day 0
measure: Area of damaged regions of heart
timeFrame: day 0
Secondary outcomes:
measure: Global myocardial activity
timeFrame: day 0
measure: Qualitative score of image quality
timeFrame: day 0
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Médecine Nucléaire, Hôpital de Bichat, Assistance Publique des Hôpitaux de Paris
city: Toulouse
country: France
facility: Service de Médecine Nucléaire, Clinique Louis Pasteur
city: Vandoeuvre-les-Nancy
country: France
facility: Service de Médecine Nucléaire, Hôpital de Brabois, CHU de Nancy
Study officials:
affiliation: Service de Médecine Nucléaire, Hôpital de Brabois, 54500, Vandoeuvre-les-Nancy, France
name: Wassilia DJABALLAH
role: PRINCIPAL_INVESTIGATOR
References: