Autoimmunity in the Pathogenesis of AF

Atrial Fibrillation Clinical Trial

Official title:

The Role of Autoimmune Mechanisms in the Pathogenesis of Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03498729
• Other study ID #: 16-005678
• Secondary ID: 1K01HL135288-01
• Status: Completed
• Start date: March 5, 2018
• Est. completion date: December 9, 2021

Study information

• Verified date: February 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 9, 2021
• Est. primary completion date: December 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Peripheral Blood Sample
30mL peripheral whole blood sample

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytokines Levels	Cytokine Profiles	through study completion, approximately 3 years.

External Links

•   Mayo Clinic Clinical Trials