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Clinical Trials/NCT02869308
NCT02869308
Unknown
Not Applicable

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)

Central Hospital, Nancy, France1 site in 1 country100 target enrollmentJanuary 2014

Overview

Phase
Not Applicable
Intervention
stannous pyrophosphate
Conditions
Angioscintigraphy
Sponsor
Central Hospital, Nancy, France
Enrollment
100
Locations
1
Primary Endpoint
Comparison of measurement of LVEF with conventional camera and semiconductor camera analyzed by two different person
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
May 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Myocardial angioscintigraphy

Intervention: stannous pyrophosphate

Myocardial angioscintigraphy

Intervention: Technetium-99m

Myocardial angioscintigraphy

Intervention: E-CAM Camera

Myocardial angioscintigraphy

Intervention: CZT Semiconductor Camera (D-SPECT)

Outcomes

Primary Outcomes

Comparison of measurement of LVEF with conventional camera and semiconductor camera analyzed by two different person

Time Frame: day 0

Secondary Outcomes

  • 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)
  • 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 cardiomyopathies(day 0)
  • Measurements of LVEF with cardiac activity recorded by D-SPECT camera artificially diminished of 50%(day 0)

Study Sites (1)

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