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

August 16, 2016 updated by: Central Hospital, Nancy, France

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)

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France
        • Recruiting
        • CHU de NANCY - Service de Médecine Nucléaire
        • Contact:
          • Gilles KARCHER, Pr
        • Sub-Investigator:
          • Olivier MOREL, Dr
        • Sub-Investigator:
          • Wassila DJABALLAH, Dr
        • Sub-Investigator:
          • Solène GRANDPIERRE-PARIS, Dr
        • Sub-Investigator:
          • Pierre-Yves MARIE, Pr
        • Sub-Investigator:
          • Elodie MATHIAS, Dr
        • Sub-Investigator:
          • Fanny NETTER, Dr
        • Sub-Investigator:
          • Antoine VERGER, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Myocardial angioscintigraphy
Drug: stannous pyrophosphate
Injection of 1ml Angiocis
Other Names:
  • Angiocis
Drug: Technetium-99m
Injection of 900 MBq Technetium-99m, 30 min after Angiocis injection
Device: E-CAM Camera
Acquisition of images of angioscintigraphy with E-CAM camera, after injection of Angiocis and Technetium-99m
Device: CZT Semiconductor Camera (D-SPECT)
Acquisition of images of angioscintigraphy with D-SPECT camera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of measurement of LVEF with conventional camera and semiconductor camera analyzed by two different person
Time Frame: day 0
day 0

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Gilles KARCHER, Pr, CHU de NANCY - Service de Médecine Nucléaire - France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

August 8, 2016

First Submitted That Met QC Criteria

August 15, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Estimate)

August 17, 2016

Last Update Submitted That Met QC Criteria

August 16, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2013-A00650-45

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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