NCT03498729

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

March 5, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2021

Completed
Last Updated

February 21, 2022

Status Verified

February 1, 2022

Enrollment Period

3.8 years

First QC Date

November 19, 2017

Last Update Submit

February 17, 2022

Conditions

Atrial Fibrillation

Keywords

Autoimmune Diseases

Outcome Measures

Primary Outcomes (1)

  • Cytokines Levels

    Cytokine Profiles

    through study completion, approximately 3 years.

Study Arms (4)

Persistent AF

Other: Peripheral Blood Sample

Paroxysmal AF

Other: Peripheral Blood Sample

Psoriasis

Other: Peripheral Blood Sample

Healthy Controls

Other: Peripheral Blood Sample

Interventions

Peripheral Blood SampleOTHER

30mL peripheral whole blood sample

Healthy ControlsParoxysmal AFPersistent AFPsoriasis

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients 18 years and older.

You may qualify if:

  • Cases: AF (Persistent, paroxysmal AF)
  • Controls 1: (No prior history of AF or inflammatory or autoimmune diseases)
  • Controls 2: (biopsy proven Psoriasis)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Atrial FibrillationAutoimmune Diseases

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsImmune System Diseases

Study Officials

  • Rowlens M. Melduni, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

November 19, 2017

First Posted

April 17, 2018

Study Start

March 5, 2018

Primary Completion

December 9, 2021

Study Completion

December 9, 2021

Last Updated

February 21, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)