- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00169936
Magnetocardiography as a Non-Invasive Tool for Detecting Tissue Rejection in Heart Transplant Patients
January 26, 2010 updated by: Mayo Clinic
Evaluation of Magnetocardiography as a Tool for Non-invasive Detection of Tissue Rejection in Cardiac Transplant Recipients
Heart transplantation is a great procedure for selected patients with end-stage heart failure, but graft rejection remains a major factor limiting long-term survival despite continued advancement in the scientific skill of immunosuppression.
The only reliable method used today to detect rejection is doing repeated biopsy of the heart.
This is expensive, invasive, inconvenient to the patient, and associated with a significant risk of serious complications, as a piece directly from the inner surface of the patients heart is needed.
The magnetocardiograph (MCG) device is an invention that may provide new means to assess changes in the heart tissue, as it may detect small changes that happen in the heart cells when they are undergoing rejection.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Heart transplantation is an advantageous procedure for selected patients with end-stage heart failure.
Graft rejection remains a major factor limiting long-term survival despite continued advancement in the scientific skill of immunosuppression.
Hyperacute rejection occurs rarely since screening of recipient for anti-donor antibodies was introduced.
Focal or diffuse acute cellular rejection is diagnosed by endomyocardial biopsy (EMB).
Coronary angiography (CA) is used to monitor for allograft arteriopathy, also described as chronic rejection.
Repeated endomyocardial biopsy (EMB) remains the only surveillance method available.
Endomyocardial biopsy is expensive, invasive, inconvenient to the patient, and associated with a significant incidence of serious complications.
The MCG device is an invention that may provide a sensitive and objective means to assess alterations in the heart tissue.
Because the acute inflammatory process of rejection deleteriously affects myocyte structure and function, we hypothesize that either or both the de- and re-polarization changes will occur in the cardiac cycle with subsequent changes in the cardiac magnetic fields and may give altered readings in the affected patient over time.
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult heart transplant recipients referred for surveillance biopsies
- Age greater than 18 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Determine the magnetocardiographic changes in de- and/or re-polarization patterns in patients with tissue rejection relative to initial MCG reading obtained during no rejection.
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Secondary Outcome Measures
Outcome Measure |
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Determine the reproducibility of the MCG between two different recordings performed at times when rejection is histologically absent (grade 0-endomyocardial biopsy).
|
Differentiate the MCG results between time of grade 0 biopsy and that of the different rejection grades.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter A Smars, MD, Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Primary Completion (Actual)
January 1, 2007
Study Completion (Actual)
January 1, 2007
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
January 28, 2010
Last Update Submitted That Met QC Criteria
January 26, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- 20-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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