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OpenTrials
Completed

NCT Number: NCT03498729

Autoimmunity in the Pathogenesis of AF

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

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peripheral Blood Sample

Other

30mL peripheral whole blood sample

Primary outcomes

  1. Cytokines Levels

    Time frame: through study completion, approximately 3 years.

    Cytokine Profiles

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Official study title

The Role of Autoimmune Mechanisms in the Pathogenesis of Atrial Fibrillation

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 17, 2018
Registry last updated
Feb 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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