Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169936
Status:
COMPLETED
Last Update Posted:
2010-01-28
First Post:
2005-09-12
Brief Title:
Magnetocardiography as a Non-Invasive Tool for Detecting Tissue Rejection in Heart Transplant Patients
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Evaluation of Magnetocardiography as a Tool for Non-invasive Detection of Tissue Rejection in Cardiac Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None