Non-invasive Evaluation of Heart Transplant Rejection- Pilot Study
|ClinicalTrials.gov Identifier: NCT00572286|
Recruitment Status : Withdrawn (sponsor funding)
First Posted : December 13, 2007
Last Update Posted : November 17, 2009
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|
|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|
heart transplant patient ( pre or post)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00572286
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Kirsten Tolstrup, MD||Cedars-Sinai Medical Center|