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

NCT ID: NCT00576186

Last Updated: 2016-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-02-28

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Congestive Heart Failure Ventricular Function, Left

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Albert J Sinusas, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15094446 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15061268 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12791827 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11752072 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11593204 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9657401 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15172417 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11593205 (View on PubMed)

Other Identifiers

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27168

Identifier Type: -

Identifier Source: org_study_id

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