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Determination of Left Ventricular Ejection Fraction Using Cardiac Angioscintigraphy

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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02869308
Acronym
FEVED
Enrollment
100
Registered
2016-08-16
Start date
2014-01-31
Completion date
2018-05-31
Last updated
2016-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angioscintigraphy, Tomoscintigraphy

Keywords

Cardiomyopathy, Chemotherapy, Left ventricular ejection fraction

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.

Interventions

DRUGTechnetium-99m

Injection of 900 MBq Technetium-99m, 30 min after Angiocis injection

DEVICEE-CAM Camera

Acquisition of images of angioscintigraphy with E-CAM camera, after injection of Angiocis and Technetium-99m

DRUGstannous pyrophosphate

Injection of 1ml Angiocis

DEVICECZT Semiconductor Camera (D-SPECT)

Acquisition of images of angioscintigraphy with D-SPECT camera

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Comparison of measurement of LVEF with conventional camera and semiconductor camera analyzed by two different personday 0

Secondary

MeasureTime frame
Measurements of LVEF with cardiac activity recorded by D-SPECT camera artificially diminished of 25%day 0
Measurements of LVEF with cardiac activity recorded by D-SPECT camera artificially diminished of 50%day 0
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 having cardiomyopathiesday 0
Comparison of measurements of LVEF with conventional camera and semiconductor camera in group of patients under LVEF supervision for chemotherapyday 0

Countries

France

Contacts

Primary ContactGilles KARCHER, Pr
g.karcher@chru-nancy.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026