Sponsor study identifier
observational
20
1 country
1
Study Start
October 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this research study is to apply new non-invasive, no-risk techniques to a cardiac transplant population for assessment of their reliability in detecting heart transplant rejection. Graft rejection remains a major factor limiting long-term survival despite continued advancement in the use of immunosuppression. Aggressive surveillance for the detection of acute rejection is therefore necessary. Repeated endomyocardial biopsy (EMB) (at least 11 times the first year after transplantation) remains the only reliable surveillance method available. EMB is expensive, invasive, inconvenient to the patient, and associated with a significant incidence of serious complications. Therefore, it would be very important for patient care if new no-risk methods would prove to be effective in surveillance of rejection. This research study is designed to measure non-invasive ways to assess rejection along with the standard planned endomyocardial biopsies you will have after heart transplantation. First, the investigators plan to test the effectiveness of the investigational use of the CMI 2406 Magnetocardiograph that has been approved by the U.S Food and Drug Administration (FDA). While the device used in the study is FDA-approved for the non-invasive measurements and recordings of the heart's magnetic field reflecting the heart's electrical currents, it is not yet approved for the specific use of detection of transplant rejection.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2005
Date type not reportedThis date has not been verified as actual or estimated.
December 12, 2007
Actual (reported)December 13, 2007
Actual (reported)December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
heart transplant patient ( pre or post)
Patients who will have heart transplantation or who have had heart transplantation
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Stengel SM, Allemann Y, Zimmerli M, Lipp E, Kucher N, Mohacsi P, Seiler C. Doppler tissue imaging for assessing left ventricular diastolic dysfunction in heart transplant rejection. Heart. 2001 Oct;86(4):432-7. doi: 10.1136/heart.86.4.432.
Derumeaux G, Douillet R, Redonnet M, Mouton-Schleifer D, Soyer R, Cribier A, Letac B. [Detection of acute rejection of heart transplantation by Doppler color imaging]. Arch Mal Coeur Vaiss. 1998 Oct;91(10):1255-62. French.
Kirsten Tolstrup, MD
Cedars-Sinai Medical Center
First Submitted
December 12, 2007
First Posted
December 13, 2007
Study Start
October 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Estimated (date passed)Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients
Contact the study team to confirm eligibility.
Mankad S, Murali S, Kormos RL, Mandarino WA, Gorcsan J 3rd. Evaluation of the potential role of color-coded tissue Doppler echocardiography in the detection of allograft rejection in heart transplant recipients. Am Heart J. 1999 Oct;138(4 Pt 1):721-30. doi: 10.1016/s0002-8703(99)70188-2.
Bu L, Munns S, Zhang H, Disterhoft M, Dixon M, Stolpen A, Sonka M, Scholz TD, Mahoney LT, Ge S. Rapid full volume data acquisition by real-time 3-dimensional echocardiography for assessment of left ventricular indexes in children: a validation study compared with magnetic resonance imaging. J Am Soc Echocardiogr. 2005 Apr;18(4):299-305. doi: 10.1016/j.echo.2004.11.002.
Mannaerts HF, van der Heide JA, Kamp O, Stoel MG, Twisk J, Visser CA. Early identification of left ventricular remodelling after myocardial infarction, assessed by transthoracic 3D echocardiography. Eur Heart J. 2004 Apr;25(8):680-7. doi: 10.1016/j.ehj.2004.02.030.
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.
7.Stroink G, Moshage W, Achenbach S. Cardiomagnetism. In: Andrä W, Nowak H, editors. Magnetism in Medicine.WILEY-VCH Verlag Berlin GmbH. 1998:136-189.
Plonsey R. Comparative capabilities of electrocardiography and magnetocardiography. Am J Cardiol. 1972 May;29(5):735-6. doi: 10.1016/0002-9149(72)90179-8. No abstract available.
9.Hänninen H, Takala P, Mäkijärvi M, et al. Detection of exercise-induced myocardial ischemia by multichannel magnetocardiography in single vessel coronary artery disease. A.N.E. 2000;5:147-157.
Hanninen H, Takala P, Korhonen P, Oikarinen L, Makijarvi M, Nenonen J, Katila T, Toivonen L. Features of ST segment and T-wave in exercise-induced myocardial ischemia evaluated with multichannel magnetocardiography. Ann Med. 2002;34(2):120-9. doi: 10.1080/07853890252953518.
11.Schmitz L, Koch H, Brockmeier K, Müller J, Schüler S, Warnecke H, et al. Magnetocardiographic diagnosis of graft rejection after heart transplantation. In Biomagnetism: Clinical Aspects. Elsevier Science Publishers, Amsterdam. 1992.
12.Achenbach S, Moshage W, Fürst S, Killmann R, Mundl H, Permanetter B et al. Investigation of magnetocardiographic parameters for the detection of graft rejection after heart transplantation. In Biomagnetism: Fundemental research and clinical applications. IOS Press, Amsterdam. 1995.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 17, 2009
Record last verified: 2009-11
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