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Autoimmunity in the Pathogenesis of AF

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT03498729
Collaborator
National Institutes of Health (NIH) (NIH), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
75
Enrollment
1
Location
45.2
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Peripheral Blood Sample

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
Actual Enrollment :
75 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Role of Autoimmune Mechanisms in the Pathogenesis of Atrial Fibrillation
Actual Study Start Date :
Mar 5, 2018
Actual Primary Completion Date :
Dec 9, 2021
Actual Study Completion Date :
Dec 9, 2021

Arms and Interventions

Arm Intervention/Treatment
Persistent AF

Other: Peripheral Blood Sample
30mL peripheral whole blood sample
Paroxysmal AF

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

Other: Peripheral Blood Sample
30mL peripheral whole blood sample
Healthy Controls

Other: Peripheral Blood Sample
30mL peripheral whole blood sample

Outcome Measures

Primary Outcome Measures

  1. Cytokines Levels [through study completion, approximately 3 years.]

    Cytokine Profiles

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Rochester Minnesota United States 55905

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Rowlens M. Melduni, Consultant, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT03498729
Other Study ID Numbers:
  • 16-005678
  • 1K01HL135288-01
First Posted:
Apr 17, 2018
Last Update Posted:
Feb 21, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rowlens M. Melduni, Consultant, Mayo Clinic
Autoimmune Diseases
Additional relevant MeSH terms:
Atrial Fibrillation

Study Results

No Results Posted as of Feb 21, 2022