Comparison Between Myocardial Tomoscintigraphies Using a Semiconductor Camera or a Conventional Camera

Myocardial Infarction Clinical Trial

— DSPECT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02861235
• Other study ID #: 2009-A00422-55
• Status: Completed
• Phase: N/A
• First received: July 29, 2016
• Last updated: August 5, 2016
• Start date: November 2009
• Est. completion date: May 2010

Study information

• Verified date: August 2016
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Infarction
• Ischemia
• Myocardial Infarction

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ejection fraction of link ventricle		day 0	No
Primary	Telesystolic volume of link ventricle		day 0	No
Primary	Telediastolic volume of link ventricle		day 0	No
Primary	Diagnosis of stress ischemia with Myocardial Tomoscintigraphy data		day 0	No
Primary	Area of damaged regions of heart		day 0	No
Secondary	Global myocardial activity		day 0	No
Secondary	Qualitative score of image quality		day 0	No