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

Heart Transplantation Clinical Trial

Official title:

Evaluation of Magnetocardiography as a Tool for Non-invasive Detection of Tissue Rejection in Cardiac Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00169936
• Other study ID #: 20-05
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: January 26, 2010
• Start date: December 2004
• Est. completion date: January 2007

Study information

• Verified date: January 2010
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult heart transplant recipients referred for surveillance biopsies

• Age greater than 18 years old

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heart Transplantation

Intervention

Device:
• Magnetocardiograph

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	CardioMag Imaging

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	Determine the reproducibility of the MCG between two different recordings performed at times when rejection is histologically absent (grade 0-endomyocardial biopsy).
Secondary	Differentiate the MCG results between time of grade 0 biopsy and that of the different rejection grades.