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Autoimmunity in the Pathogenesis of AF

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ClinicalTrials.gov Identifier: NCT03498729
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : May 23, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Rowlens M. Melduni, Mayo Clinic

Study Description
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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
Atrial Fibrillation 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
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Study Type : Observational
Estimated Enrollment : 240 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 : March 5, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Cytokines Levels [ Time Frame: through study completion, approximately 3 years. ]
    Cytokine Profiles


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adult patients 18 years and older.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498729


Contacts
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Contact: Rowlens M. Melduni, M.D., M.P.H. (507) 538-0325 Melduni.Rowlens@mayo.edu
Contact: Hannah Frost (507) 293-2762 Frost.Hannah@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Rowlens M. Melduni, M.D., M.P.H.    507-538-0325    Melduni.Rowlens@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site

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Responsible Party: Rowlens M. Melduni, Consultant, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03498729     History of Changes
Other Study ID Numbers: 16-005678
1K01HL135288-01 ( U.S. NIH Grant/Contract )
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rowlens M. Melduni, Mayo Clinic:
Autoimmune Diseases
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes