Determination of Left Ventricular Ejection Fraction Using Cardiac Angioscintigraphy (FEVED)

Central Hospital, Nancy, France

Status

Unknown

Conditions

Angioscintigraphy

Tomoscintigraphy

Treatments

Drug: stannous pyrophosphate

Drug: Technetium-99m

Device: CZT Semiconductor Camera (D-SPECT)

Device: E-CAM Camera

Study type

Interventional

Funder types

Other

Identifiers

NCT02869308

2013-A00650-45

Details and patient eligibility

About

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).

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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