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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

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

Conditions
-----------------
Valve Heart Disease

Intervention / Treatment
-----------------
* Diagnostic Test: blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Biological Heart Valve<br>Participants receiving a biological heart valve | Diagnostic Test: blood draw<br>* blood will be drawn at pre-operation, between 2 weeks and 3 months, between 3-11 months (optional; we will collect a sample if the patient returns to Mayo Clinic for any other non-study related visit), and between 12-18 months post-operatively.<br>|
| Mechanical Heart Valve<br>Participants receiving a mechanical heart valve | Diagnostic Test: blood draw<br>* blood will be drawn at pre-operation, between 2 weeks and 3 months, between 3-11 months (optional; we will collect a sample if the patient returns to Mayo Clinic for any other non-study related visit), and between 12-18 months post-operatively.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify Non-gal, non-HLA protein antigens in patients that have received xenogenic tissue implant. | The captured proteins will be identified, and compared over time (i.e., pre-op, between 2 weeks and 3 months, between 3-11 months (optional), and 12-18 months post-operatively) to determine which proteins (i.e., antigens) in bovine/porcine pericardium that the patient is mounting an immune response towards. | Approximately 12-18 months post-operatively |