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

Congestive Heart Failure Clinical Trial

Official title:

Validation of the Gated Blood Pool SPECT: Comparison to ERNA and 3-dimensional Echocardiography.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00576186
• Other study ID #: 27168
• Status: Completed
• Phase: N/A
• First received: December 15, 2007
• Last updated: June 21, 2016
• Start date: February 2005
• Est. completion date: November 2015

Study information

• Verified date: June 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure
• Ventricular Function, Left

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		1 day	No