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

Active, not recruiting

• Conditions: Valve Heart Disease
• Interventions: Diagnostic Test: blood draw

• Registration Number: NCT04938960
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2021-06-22
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-25
• Study Start: 2021-07-01
• Primary Completion: 2024-03-27
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-29
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 197

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biological Heart Valve	blood draw	Participants receiving a biological heart valve
Mechanical Heart Valve	blood draw	Participants receiving a mechanical heart valve

Primary Outcome Measures

Name	Time	Method
Identify Non-gal, non-HLA protein antigens in patients that have received xenogenic tissue implant.	Approximately 12-18 months post-operatively	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.

Trial Locations

Locations (3)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic Arizona; 🇺🇸 Phoenix, Arizona, United States

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States