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Non-invasive Evaluation of Heart Transplant Rejection- Pilot Study

This study has been withdrawn prior to enrollment.
(sponsor funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00572286
First Posted: December 13, 2007
Last Update Posted: November 17, 2009
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.
Collaborator:
CardioMag Imaging
Information provided by:
Cedars-Sinai Medical Center
  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

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
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
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 ClinicalTrials.gov identifier (NCT number): 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:
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
ClinicalTrials.gov Identifier: NCT00572286     History of Changes
Other Study ID Numbers: 8144
First Submitted: December 12, 2007
First Posted: December 13, 2007
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
echocardiogram

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases