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CompletedNCT00576186Updated Jun 23, 2016

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

An observational study in Congestive Heart Failure and Ventricular Function, Left, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-23.

Sponsored by Yale University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the detailed description

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).

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Conditions studied

  • Congestive Heart Failure
  • Ventricular Function, Left

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In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 30 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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.

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

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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (actual)

Groups and cohorts

  • 1

    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).

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What researchers measure

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

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Study locations

1 site
  • Yale New Haven Hospital
    New Haven, Connecticut 06520, United States
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References and documents

Publications

  • Daou D, Coaguila C, Benada A, Razzouk M, Haidar M, Colin P, Lebtahi R, Slama M, Guludec DL. The value of a completely automatic ECG gated blood pool SPECT processing method for the estimation of global systolic left ventricular function. Nucl Med Commun. 2004 Mar;25(3):271-6. doi: 10.1097/00006231-200403000-00010. PubMed 15094446 ↗
  • Slart RH, Poot L, Piers DA, van Veldhuisen DJ, Nichols K, Jager PL. Gated blood-pool SPECT automated versus manual left ventricular function calculations. Nucl Med Commun. 2004 Jan;25(1):75-80. doi: 10.1097/00006231-200401000-00011. PubMed 15061268 ↗
  • De Bondt P, Nichols K, Vandenberghe S, Segers P, De Winter O, Van de Wiele C, Verdonck P, Shazad A, Shoyeb AH, De Sutter J. Validation of gated blood-pool SPECT cardiac measurements tested using a biventricular dynamic physical phantom. J Nucl Med. 2003 Jun;44(6):967-72. PubMed 12791827 ↗
  • Groch MW, DePuey EG, Belzberg AC, Erwin WD, Kamran M, Barnett CA, Hendel RC, Spies SM, Ali A, Marshall RC. Planar imaging versus gated blood-pool SPECT for the assessment of ventricular performance: a multicenter study. J Nucl Med. 2001 Dec;42(12):1773-9. PubMed 11752072 ↗
  • Mondelli JA, Di Luzio S, Nagaraj A, Kane BJ, Smulevitz B, Nagaraj AV, Greene R, McPherson DD, Rigolin VH. The validation of volumetric real-time 3-dimensional echocardiography for the determination of left ventricular function. J Am Soc Echocardiogr. 2001 Oct;14(10):994-1000. doi: 10.1067/mje.2001.115770. PubMed 11593204 ↗
  • Nosir YF, Salustri A, Kasprzak JD, Breburda CS, Ten Cate FJ, Roelandt JR. Left ventricular ejection fraction in patients with normal and distorted left ventricular shape by three-dimensional echocardiographic methods: a comparison with radionuclide angiography. J Am Soc Echocardiogr. 1998 Jun;11(6):620-30. doi: 10.1016/s0894-7317(98)70038-0. PubMed 9657401 ↗
  • Kuhl HP, Schreckenberg M, Rulands D, Katoh M, Schafer W, Schummers G, Bucker A, Hanrath P, Franke A. High-resolution transthoracic real-time three-dimensional echocardiography: quantitation of cardiac volumes and function using semi-automatic border detection and comparison with cardiac magnetic resonance imaging. J Am Coll Cardiol. 2004 Jun 2;43(11):2083-90. doi: 10.1016/j.jacc.2004.01.037. PubMed 15172417 ↗
  • Lee D, Fuisz AR, Fan PH, Hsu TL, Liu CP, Chiang HT. Real-time 3-dimensional echocardiographic evaluation of left ventricular volume: correlation with magnetic resonance imaging--a validation study. J Am Soc Echocardiogr. 2001 Oct;14(10):1001-9. doi: 10.1067/mje.2001.113647. PubMed 11593205 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00576186
Lead sponsor
Yale University
Responsible party
Sponsor
First posted
Dec 18, 2007
Start date
Feb 2005
Primary completion
Nov 2015
Completion
Nov 2015
Last update
Jun 23, 2016

Study contacts

Albert J Sinusas, MD
principal investigator · Yale University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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