Clinical trial NCT02869308: Determination of Left Ventricular Ejection Fraction Using Cardiac Angioscintigraphy
Official title: Determination of Left Ventricular Ejection Fraction Using Cardiac Angioscintigraphy: Comparison Between Measurements Obtained With Conventional Planar Scintigraphy (E-CAM Camera) and Tomoscintigraphy Recorded by a CZT Semiconductor Camera (D-SPECT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Angioscintigraphy
Tomoscintigraphy
Keywords: Cardiomyopathy
Chemotherapy
Left ventricular ejection fraction
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose is to determine whether measurements of left ventricular ejection fraction (LVEF) obtained with angiographies recorded by conventional Anger camera or D-SPECT camera are equivalent.

Secondary purposes are:

* To evaluate the influence of cardiac activity recorded by D-SPECT camera on equivalences defined in primary purpose
* To evaluate the influence of the indication for the examination with a distinct analysis of a group having the examination for a known or suspected cardiomyopathy (LVEF often abnormally low) and a group having the examination for a chemotherapy supervision with heart initially considered healthy (LVEF often normal).

Detailed description: Cardiac angioscintigraphy is an examination for a simple, precise and reproducible measurement of left ventricular ejection fraction (LVEF). It needs injection of 99mTc labeled albumin or red cells and unfortunately injected activities must be relatively considerable (≈ 900 MBq) for image recording times shorter than 10 minutes. This examination is thus quite irradiant (10 mSv) but this inconvenient could be eliminated with new semiconductor cameras.

These new cameras allow a better image quality than conventional Anger cameras (better spatial resolution and energy) and their detection sensitivity is almost 10 times higher. However, these new cameras can record only 3D images whereas with conventional cameras angioscintigraphy is usually performed in bidimensional way with a possible higher precision and reproducibility of LVEF measurement.

In this study, patients needing the routine examination for LVEF measurements will undergo the conventional examination followed by examination with semiconductor camera (without supplementary injection).

If LVEF measurement with semiconductor camera will be as precise and reproducible as with conventional camera, angioscintigraphy could be performed with these new cameras with a lower body irradiation of patients.

Eligibility criteria: Inclusion Criteria:

* Patients present in Nuclear Medicine department for measurement of LVEF by cardiac angioscintigraphy for known or suspected cardiomyopathy or for a chemotherapy supervision with heart initially considered healthy
* Without guardianship, signed informed consent
* Not in life-and-death emergency and with a stable clinical state
* Affiliated to social security
* Preliminary medical examination

Exclusion Criteria:

* Patients having rhythm disorders (atrial or ventricular extrasystoles in more than 20% cardiac cycles, atrial fibrillation)
* Incapable to stay in strict decubitus position during image recording times
* Pregnant or breastfeeding women

Primary outcomes:
measure: Comparison of measurement of LVEF with conventional camera and semiconductor camera analyzed by two different person
timeFrame: day 0
Secondary outcomes:
measure: Measurements of LVEF with cardiac activity recorded by D-SPECT camera artificially diminished of 25%
timeFrame: day 0
measure: Measurements of LVEF with cardiac activity recorded by D-SPECT camera artificially diminished of 50%
timeFrame: day 0
measure: Measurements of LVEF with cardiac activity recorded by D-SPECT camera artificially diminished of 75%
timeFrame: day 0
measure: Comparison of measurements of LVEF with conventional camera and semiconductor camera in group of patients having cardiomyopathies
timeFrame: day 0
measure: Comparison of measurements of LVEF with conventional camera and semiconductor camera in group of patients under LVEF supervision for chemotherapy
timeFrame: day 0
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHU de NANCY - Service de Médecine Nucléaire
Study officials:
affiliation: CHU de NANCY - Service de Médecine Nucléaire - France
name: Gilles KARCHER, Pr
role: PRINCIPAL_INVESTIGATOR
References: