Determination of Left Ventricular Ejection Fraction Using Cardiac Angioscintigraphy

NCT ID: NCT02869308

Last Updated: 2016-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2018-05-31

Brief Summary

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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

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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.

Conditions

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Angioscintigraphy Tomoscintigraphy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Myocardial angioscintigraphy

Group Type OTHER

stannous pyrophosphate

Intervention Type DRUG

Injection of 1ml Angiocis

Technetium-99m

Intervention Type DRUG

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

E-CAM Camera

Intervention Type DEVICE

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

CZT Semiconductor Camera (D-SPECT)

Intervention Type DEVICE

Acquisition of images of angioscintigraphy with D-SPECT camera

Interventions

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stannous pyrophosphate

Injection of 1ml Angiocis

Intervention Type DRUG

Technetium-99m

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

Intervention Type DRUG

E-CAM Camera

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

Intervention Type DEVICE

CZT Semiconductor Camera (D-SPECT)

Acquisition of images of angioscintigraphy with D-SPECT camera

Intervention Type DEVICE

Other Intervention Names

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Angiocis

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilles KARCHER, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU de NANCY - Service de Médecine Nucléaire - France

Locations

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CHU de NANCY - Service de Médecine Nucléaire

Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Gilles KARCHER, Pr

Role: CONTACT

Facility Contacts

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Gilles KARCHER, Pr

Role: primary

Other Identifiers

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2013-A00650-45

Identifier Type: -

Identifier Source: org_study_id

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