Autoimmunity in the Pathogenesis of AF

Completed

• Conditions: Atrial Fibrillation
• Interventions: Other: Peripheral Blood Sample

• Registration Number: NCT03498729
• Lead Sponsor: Mayo Clinic

Brief Summary

This research study is being done to find out whether autoimmune mechanisms are associated with the development of atrial fibrillation.

Detailed Description

The study sets out to identify an explanation for the pathogenesis of AF, potentially forming the basis for designing novel targeted therapies to prevent or reverse this prevalent human disease. The overall objectives are to determine whether autoimmune diseases are associated with AF development and to identify specific diagnostic and prognostic biomarkers that will improve the ability to accurately predict risk of AF development. The study will prospectively enroll patients with and without AF and determine their serum cytokine levels and assess the functional responses of T cells on the basis of cytokine production after in vitro T-cell specific stimulation, using Luminex bead-based multiplex technology.

Study Timeline

• Study First Submitted: 2017-11-19
• Study Start: 2018-03-05
• Study First Submitted QC: 2018-04-12
• Study First Posted: 2018-04-17
• Primary Completion: 2021-12-09
• Study Completion: 2021-12-09
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-17
• Last Update Posted: 2022-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Cases: AF (Persistent, paroxysmal AF)
• Controls 1: (No prior history of AF or inflammatory or autoimmune diseases)
• Controls 2: (biopsy proven Psoriasis)

Exclusion Criteria

• Clinically apparent acute infections over the past 4 weeks
• Chronic infections
• Recent malignancies
• Recent Radiation or chemotherapy
• Chronic kidney disease (≥ stage 2)
• Organ transplantation
• History of chronic liver disease
• Major surgery or invasive procedure in the past 6 months
• Internal prosthesis
• Receiving immunosuppressive therapy
• Known rheumatologic diseases (except for the participants with psoriasis)
• Females who are known to be pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Paroxysmal AF	Peripheral Blood Sample	-
Psoriasis	Peripheral Blood Sample	-
Healthy Controls	Peripheral Blood Sample	-
Persistent AF	Peripheral Blood Sample	-

Primary Outcome Measures

Name	Time	Method
Cytokines Levels	through study completion, approximately 3 years.	Cytokine Profiles

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States