Clinical trial NCT04938960: Identification of Non-gal, Non-HLA Antigens in Patients Implanted With Xenogenic Material
Official title: Identification of Non-gal, Non-HLA Antigens in Patients Implanted With Xenogenic Material
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Valve Heart Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult males and females who will receive either a mechanical or biological heart valve implant

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.

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

Primary outcomes:
measure: Identify Non-gal, non-HLA protein antigens in patients that have received xenogenic tissue implant.
timeFrame: Approximately 12-18 months post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Leigh G Griffiths, PhD
role: PRINCIPAL_INVESTIGATOR
References: