Identification of Non-gal, Non-HLA Antigens in Patients Implanted With Xenogenic Material

Mayo Clinic

Status: Completed

Conditions: Valve Heart Disease

Treatments: Diagnostic Test: blood draw

Study type: Observational

Funder types: Other

Identifiers

NCT04938960

17-007803

Details and patient eligibility

About

This study involves collecting serum samples from patients presenting for aortic valve replacement at Mayo Clinic, Rochester, MN. Serum samples will be collected pre-op, between 2 weeks and 3 months, between 3-11 months (optional), and between 12-18 months post-operatively. The patients antibodies in these serum samples will be used to capture proteins from the same type of tissue their replacement heart valves are made from (i.e., bovine/porcine pericardium - a non-human tissue which is currently used to make glutaraldehyde-fixed heart valves). The captured proteins will be identified, and compared over time (i.e., 0, 1, 3 and 12 months) to determine which proteins (i.e., antigens) in bovine/porcine pericardium that the patient is mounting an immune response towards.

Full description

Protein G HP SpinTrap columns will be used to capture IgG antibodies from patient serum pre-implant, between 2 weeks-3 months, between 3-11 months and between 12-18 months post-implant. These antibodies will be cross-linked to the column and then protein extracted from implant tissue (ie Native bovine/porcine pericardium) will be deglycosylated and run through the column. Antigenic proteins will be trapped and non-antigenic proteins will be washed through the column. These antigenic proteins will be eluted off the column and identified using LC-MS/MS. The proteins identified in the pre-implant elutant will be compared to the proteins in post-implant elutant to identify xenoantigens. Success criteria will be method validation by identification of previously known and new currently unknown xenoantigens.

Enrollment: 197 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients who will receive either a biological or mechanical heart valve

Exclusion criteria

• Currently receiving therapy for cancer requiring treatment with concurrent radiotherapy and/or chemotherapy
• Cancer in remission for less than 5 years if previously treated with radiotherapy and/or chemotherapy
• Previous tissue valve implants
• Current pregnancy

Trial design

197 participants in 2 patient groups

Biological Heart Valve

Description:

Participants receiving a biological heart valve

Treatment:

Diagnostic Test: blood draw

Mechanical Heart Valve

Description:

Participants receiving a mechanical heart valve

Treatment:

Diagnostic Test: blood draw