Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Yale University.
Recruitment status was  Recruiting
Information provided by:
Yale University Identifier:
First received: December 15, 2007
Last updated: January 13, 2010
Last verified: January 2010

December 15, 2007
January 13, 2010
February 2005
Not Provided
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 Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
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 Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
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
Not Provided
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 Identifier (NCT Number) in Medline.
January 2011
Not Provided

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.
18 Years and older
Contact: Carol Akirav, MSc 203-785-2429
Contact: Albert J Sinusas, MD 203-785-3155
United States
Dr. Albert Sinusas/Prof of Int Med & Diagnostic Radiology, Yale University
Yale University
Not Provided
Principal Investigator: Albert J Sinusas, MD Yale University
Yale University
January 2010

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