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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biological Heart Valve | Participants receiving a biological heart valve |
| |
| Mechanical Heart Valve | Participants receiving a mechanical heart valve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood draw | Diagnostic Test | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult males and females who will receive either a mechanical or biological heart valve implant
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| Name | Affiliation | Role |
|---|---|---|
| Leigh G Griffiths, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | United States | ||
| Mayo Clinic Florida |
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| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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serum samples
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |