Autoimmunity in the Pathogenesis of AF

February 17, 2022 updated by: Rowlens M. Melduni, Mayo Clinic

The Role of Autoimmune Mechanisms in the Pathogenesis of Atrial Fibrillation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients 18 years and older.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Controls
Other: Peripheral Blood Sample
30mL peripheral whole blood sample
Psoriasis
Other: Peripheral Blood Sample
30mL peripheral whole blood sample
Persistent AF
Other: Peripheral Blood Sample
30mL peripheral whole blood sample
Paroxysmal AF
Other: Peripheral Blood Sample
30mL peripheral whole blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cytokines Levels
Time Frame: through study completion, approximately 3 years.
Cytokine Profiles
through study completion, approximately 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

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

Investigators

  • Principal Investigator: Rowlens M. Melduni, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2018

Primary Completion (Actual)

December 9, 2021

Study Completion (Actual)

December 9, 2021

Study Registration Dates

First Submitted

November 19, 2017

First Submitted That Met QC Criteria

April 12, 2018

First Posted (Actual)

April 17, 2018

Study Record Updates

Last Update Posted (Actual)

February 21, 2022

Last Update Submitted That Met QC Criteria

February 17, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-005678
  • 1K01HL135288-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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