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Completed

NCT Number: NCT00576186

Validation of the Gated Blood Pool SPECT: ERNA vs 3D Echo

This research study is designed to evaluate the accuracy of the techniques that are used to analyze heart function. The main purpose of this study is to analyze and compare three different methods of assessment of regional and overall heart function.

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure Ventricular Function, Left

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

About this study

The purpose of the present study is to establish the reproducibility and to validate gated blood pool SPECT imaging with application of attenuation correction (ACGBS) in evaluation of left ventricular regional and global function and volumes, by direct comparison with Equilibrium Radionuclide Angiocardiography (ERNA) and 3-dimensional ECHO (3DE).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients scheduled for routine clinically requested ERNA study for ejection fraction measurement at the Yale University Cardiovascular Nuclear Imaging Laboratory are eligible to be enrolled in the study.

Exclusion criteria

  • Unstable medical condition preventing additional imaging.
  • Weight greater than 300lbs, prohibiting imaging on the SPECT/CT imaging system.
  • Patients with intracardiac shunts, emphysema or previously demonstrated allergies to octafluoropropane (the gas in the microbubbles), will not receive intravenous contrast during 3 DE image acquisition.

Treatment and study plan

Primary outcomes

  1. 2D echo provides a good estimate of regional LV function but if done with 3D analysis can provide a good estimate of global LV function and volumes. The quality of 3DE can be further improved by use of IV contrast which is FDA approved.

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Validation of the Gated Blood Pool SPECT: Comparison to ERNA and 3-dimensional Echocardiography.

Important dates

Study start
2005
Primary completion
2015
Study completion
2015
First posted
Dec 18, 2007
Registry last updated
Jun 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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