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Non-invasive Evaluation of Heart Transplant Rejection- Pilot Study

NCT00572286 · Status: WITHDRAWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2009-11-17

No results posted yet for this study

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

Sponsors & Collaborators

  • CardioMag Imaging

    collaborator INDUSTRY

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Kirsten Tolstrup, MD · Cedars-Sinai Medical Center

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00572286 on ClinicalTrials.gov