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Clinical Trials/NCT03498729
NCT03498729CompletedNot Applicable

The Role of Autoimmune Mechanisms in the Pathogenesis of Atrial Fibrillation

Mayo Clinic1 site in 1 country75 target enrollmentStarted: March 5, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
75
Locations
1
Primary Endpoint
Cytokines Levels

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Cytokines Levels

Time Frame: through study completion, approximately 3 years.

Cytokine Profiles

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rowlens M. Melduni

Consultant

Mayo Clinic

Study Sites (1)

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