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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00576186
First received: December 15, 2007
Last updated: June 21, 2016
Last verified: June 2016

December 15, 2007
June 21, 2016
February 2005
November 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00576186 on ClinicalTrials.gov Archive Site
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Validation of the Gated Blood Pool SPECT: ERNA vs 3D Echo
Validation of the Gated Blood Pool SPECT: Comparison to ERNA and 3-dimensional Echocardiography.
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.
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).
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample
Each patient scheduled to undergo clinically requested ERNA imaging for assessment of LV function in the Yale University Cardiovascular Nuclear Imaging Laboratory will be an eligible candidate and will be asked to participate. Based on our referral pattern it will include both patients with cardiac and non-cardiac disease, the later usually consist of patients undergoing chemotherapy.
  • Congestive Heart Failure
  • Ventricular Function, Left
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Patients being referred for the routine Equilibrium Radionuclide Angiocardiography (ERNA) for assessment of their left ventricular function will be asked to participate in the study. All patients will be asked to sign the consent form. Patients will be given a choice to participate in either or both studies (i.e. ERNA plus ACGBS or ERNA plus ACGBS and 3 DE).

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
November 2015
November 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00576186
27168
No
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Yale University
Yale University
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Principal Investigator: Albert J Sinusas, MD Yale University
Yale University
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP