Determination of Left Ventricular Ejection Fraction Using Cardiac Angioscintigraphy

Not Applicable

• Conditions: Angioscintigraphy; Tomoscintigraphy
• Interventions: Drug: stannous pyrophosphate; Drug: Technetium-99m; Device: E-CAM Camera; Device: CZT Semiconductor Camera (D-SPECT)

• Registration Number: NCT02869308
• Lead Sponsor: Central Hospital, Nancy, France

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.

Study Timeline

• Study Start: 2014-01
• Status Verified: 2016-08
• Study First Submitted: 2016-08-08
• Study First Submitted QC: 2016-08-15
• Study First Posted: 2016-08-16
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17
• Primary Completion: 2018-01
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Myocardial angioscintigraphy	E-CAM Camera	-
Myocardial angioscintigraphy	stannous pyrophosphate	-
Myocardial angioscintigraphy	CZT Semiconductor Camera (D-SPECT)	-
Myocardial angioscintigraphy	Technetium-99m	-

Primary Outcome Measures

Name	Time	Method
Comparison of measurement of LVEF with conventional camera and semiconductor camera analyzed by two different person	day 0

Secondary Outcome Measures

Name	Time	Method
Measurements of LVEF with cardiac activity recorded by D-SPECT camera artificially diminished of 75%	day 0
Comparison of measurements of LVEF with conventional camera and semiconductor camera in group of patients under LVEF supervision for chemotherapy	day 0
Measurements of LVEF with cardiac activity recorded by D-SPECT camera artificially diminished of 25%	day 0
Comparison of measurements of LVEF with conventional camera and semiconductor camera in group of patients having cardiomyopathies	day 0
Measurements of LVEF with cardiac activity recorded by D-SPECT camera artificially diminished of 50%	day 0

Trial Locations

Locations (1)

CHU de NANCY - Service de Médecine Nucléaire; 🇫🇷 Nancy, France