Comparison Between Myocardial Tomoscintigraphies Using a Semiconductor Camera or a Conventional Camera
DSPECT
1 other identifier
interventional
276
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2009
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 29, 2016
CompletedFirst Posted
Study publicly available on registry
August 10, 2016
CompletedAugust 10, 2016
August 1, 2016
6 months
July 29, 2016
August 5, 2016
Conditions
Outcome Measures
Primary Outcomes (5)
Ejection fraction of link ventricle
day 0
Telesystolic volume of link ventricle
day 0
Telediastolic volume of link ventricle
day 0
Diagnosis of stress ischemia with Myocardial Tomoscintigraphy data
day 0
Area of damaged regions of heart
day 0
Secondary Outcomes (2)
Global myocardial activity
day 0
Qualitative score of image quality
day 0
Study Arms (6)
1. stress thallium-201 tomoscintigraphy
EXPERIMENTAL2. stress technetium-99m tomoscintigraphy 1
EXPERIMENTAL3. stress technetium-99m tomoscintigraphy 2
EXPERIMENTAL4. stress technetium-99m tomoscintigraphy 3
EXPERIMENTAL5. rest thallium-201 tomoscintigraphy
EXPERIMENTAL6. rest technetium-99m tomoscintigraphy
EXPERIMENTALInterventions
with gamma-camera and D.SPECT camera
with gamma-camera and D.SPECT camera, in Toulouse centre
with gamma-camera and D.SPECT camera, in Nancy centre
with gamma-camera and D.SPECT camera, in Paris centre
rest thallium-201 tomoscintigraphy for myocardial viability assessment
rest technetium-99m tomoscintigraphy for myocardial viability assessment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patient under guardianship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Vandœuvre-lès-Nancy, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wassilia DJABALLAH
Service de Médecine Nucléaire, Hôpital de Brabois, 54500, Vandoeuvre-les-Nancy, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2016
First Posted
August 10, 2016
Study Start
November 1, 2009
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
August 10, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share