Non-invasive Evaluation of Heart Transplant Rejection- Pilot Study

This study has been withdrawn prior to enrollment.
(sponsor funding)
Sponsor:
Collaborator:
CardioMag Imaging
Information provided by:
Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00572286
First received: December 12, 2007
Last updated: November 16, 2009
Last verified: November 2009
  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:


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
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, see Learn About Clinical Studies.

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:

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 September 15, 2014