Magnetocardiography as a Non-Invasive Tool for Detecting Tissue Rejection in Heart Transplant Patients

NCT ID: NCT00169936

Last Updated: 2010-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2007-01-31

Brief Summary

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.

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.

Conditions

Heart Transplantation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Interventions

Magnetocardiograph

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult heart transplant recipients referred for surveillance biopsies
• Age greater than 18 years old

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CardioMag Imaging

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Principal Investigators

Peter A Smars, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

20-05

Identifier Type: -

Identifier Source: org_study_id