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Non-invasive Evaluation of Heart Transplant Rejection- Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00572286
Recruitment Status : Withdrawn (sponsor funding)
First Posted : December 13, 2007
Last Update Posted : November 17, 2009
CardioMag Imaging
Information provided by:
Cedars-Sinai Medical Center

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.

Condition or disease
Advanced Heart Failure Heart Transplantation

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 20 participants
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
Study Start Date : October 2005
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

heart transplant patient ( pre or post)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who will have heart transplantation or who have had heart transplantation

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00572286

United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
CardioMag Imaging
Principal Investigator: Kirsten Tolstrup, MD Cedars-Sinai Medical Center

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.
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.
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.

Responsible Party: Kirsten Tolstrup, MD, Cedars-Sinai Medical Center Identifier: NCT00572286     History of Changes
Other Study ID Numbers: 8144
First Posted: December 13, 2007    Key Record Dates
Last Update Posted: November 17, 2009
Last Verified: November 2009

Keywords provided by Cedars-Sinai Medical Center:
heart transplant
advanced heart failure
orthotropic heart transplantation
(MCG) magnetocardiograph

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases