Non-invasive Evaluation of Heart Transplant Rejection- Pilot Study - Full Text View

Purpose

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.

Condition
Advanced Heart Failure Heart Transplantation

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Evaluation of Non-invasive Methods for the Detection of Acute Rejection in Heart Transplant Patients: Use of Echocardiography and Magnetocardiography (MCG) -Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure Heart Transplantation

U.S. FDA Resources

Further study details as provided by Cedars-Sinai Medical Center:

Estimated Enrollment:	20
Study Start Date:	October 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 heart transplant patient ( pre or post)

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572286

Locations

United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048

Sponsors and Collaborators

Cedars-Sinai Medical Center

CardioMag Imaging

Investigators

Principal Investigator:

Kirsten Tolstrup, MD

Cedars-Sinai Medical Center

More Information

Publications:

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.

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. Review. French.

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.

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.

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.

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.

Plonsey R. Comparative capabilities of electrocardiography and magnetocardiography. Am J Cardiol. 1972 May;29(5):735-6. No abstract available.

Hänninen H, Takala P, Korhonen P, Oikarinen L, Mäkijärvi 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.

Responsible Party:	Kirsten Tolstrup, MD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:	NCT00572286 History of Changes
Other Study ID Numbers:	8144
Study First Received:	December 12, 2007
Last Updated:	November 16, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:

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

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013