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

Sponsor:

Information provided by:

Yale University

ClinicalTrials.gov Identifier:

NCT00576186

First received: December 15, 2007

Last updated: January 13, 2010

Last verified: January 2010

History of Changes

Purpose

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.

Condition
Congestive Heart Failure Ventricular Function, Left

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Validation of the Gated Blood Pool SPECT: Comparison to ERNA and 3-dimensional Echocardiography.

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	50
Study Start Date:	February 2005
Estimated Study Completion Date:	January 2011

Groups/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).

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576186

Contacts

Contact: Carol Akirav, MSc	203-785-2429	carol.akirav@yale.edu
Contact: Albert J Sinusas, MD	203-785-3155

Locations

United States, Connecticut
Yale New Haven Hospital	Recruiting
New Haven, Connecticut, United States, 06520
Contact: Carol Akirav, MSc 203-785-2429 carol.akirav@yale.edu
Contact: Albert J Sinusas, MD 203-785-3155 albert.sinusas@yale.edu
Sub-Investigator: Robin Doyle, MD
Sub-Investigator: Frans Walkers, MD
Sub-Investigator: Robert McNamara, MD

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator:

Albert J Sinusas, MD

Yale University

More Information

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.

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.

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.

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.

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.

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.

Kühl HP, Schreckenberg M, Rulands D, Katoh M, Schäfer W, Schummers G, Bücker 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.

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.

Responsible Party:	Dr. Albert Sinusas/Prof of Int Med & Diagnostic Radiology, Yale University
ClinicalTrials.gov Identifier:	NCT00576186 History of Changes
Other Study ID Numbers:	27168
Study First Received:	December 15, 2007
Last Updated:	January 13, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013

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