Autoimmunity in the Pathogenesis of AF

NCT ID: NCT03498729

Last Updated: 2022-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-05

Study Completion Date

2021-12-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Persistent AF

Peripheral Blood Sample

Intervention Type OTHER

30mL peripheral whole blood sample

Paroxysmal AF

Peripheral Blood Sample

Intervention Type OTHER

30mL peripheral whole blood sample

Psoriasis

Peripheral Blood Sample

Intervention Type OTHER

30mL peripheral whole blood sample

Healthy Controls

Peripheral Blood Sample

Intervention Type OTHER

30mL peripheral whole blood sample

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Peripheral Blood Sample

30mL peripheral whole blood sample

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rowlens M. Melduni

Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rowlens M. Melduni, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1K01HL135288-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

16-005678

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Phase-Aligned Atrial Fibrillation Mapping
NCT06892561 ACTIVE_NOT_RECRUITING