Non-invasive Evaluation of Heart Transplant Rejection- Pilot Study

NCT00572286 | Withdrawn

• 1 other identifier: 8144
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Heart Failure; Heart Transplantation

Keywords

heart transplant; advanced heart failure; orthotropic heart transplantation; (MCG) magnetocardiograph; echocardiogram

Study Arms (1)

1

heart transplant patient ( pre or post)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who will have heart transplantation or who have had heart transplantation

You may qualify if:

• Patients who will have heart transplantation or who have had heart transplantation AND who are scheduled for surveillance biopsies

You may not qualify if:

• Patients with Pacemakers or Implantable Cardioverter-Defibrillators(ICD)
• Patients with poor echocardiographic images
• Patients with irregular atrial fibrillation

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• CardioMag Imaging: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (12)

• 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.

  PMID: 11559685 BACKGROUND

• 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.

  PMID: 9833090 BACKGROUND

• 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.

  PMID: 10502219 BACKGROUND

• 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.

  PMID: 15846155 BACKGROUND

• 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.

  PMID: 15084373 BACKGROUND

• 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.

  PMID: 15172417 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 5021505 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 12108575 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

Study Officials

• Kirsten Tolstrup, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 13, 2007
• Study Start: October 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 17, 2009

Record last verified: 2009-11

Locations

US (1)