Atrial FibrillationNCT03498729
Autoimmunity in the Pathogenesis of AF
An observational study of Atrial Fibrillation, run by Mayo Clinic at 1 site in United States.
Trial summary
This research study is being done to find out whether autoimmune mechanisms are associated with the development of atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Peripheral Blood Sample
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2018to 9 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients 18 years and older.
Who may be able to join
- Cases: AF (Persistent, paroxysmal AF)
- Controls 1: (No prior history of AF or inflammatory or autoimmune diseases)
- Controls 2: (biopsy proven Psoriasis)
Who cannot join
- Clinically apparent acute infections over the past 4 weeks
- Chronic infections
- Recent malignancies
- Recent Radiation or chemotherapy
- Chronic kidney disease (≥ stage 2)
- Organ transplantation
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Peripheral Blood Sample
- Keywords
- Autoimmune Diseases
- Medical subject headings
- Atrial Fibrillation, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral Blood SampleOther
30mL peripheral whole blood sample
| Study group | Role | What they receive |
|---|---|---|
| Persistent AF | Not described Receives: Other: Peripheral Blood Sample | |
| Paroxysmal AF | Not described Receives: Other: Peripheral Blood Sample | |
| Psoriasis | Not described Receives: Other: Peripheral Blood Sample | |
| Healthy Controls | Not described Receives: Other: Peripheral Blood Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokines Levels
Cytokine Profiles
Measured: through study completion, approximately 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start5 Mar 2018
- Primary completion9 Dec 2021
- Study completion9 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Rowlens M. Melduni, Mayo Clinic
- Investigators
- Rowlens M. Melduni, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498729
- Sponsor's protocol ID
- 16-005678
- Other IDs
- 1K01HL135288-01
- Status last verified
- Feb 2022
- First submitted
- 19 Nov 2017
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Autoimmune Mechanisms in the Pathogenesis of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03498729
- Acronym / sponsor ID
- 16-005678
- Conditions
- Atrial Fibrillation
- Keywords
- Autoimmune Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is being done to find out whether autoimmune mechanisms are associated with the development of atrial fibrillation.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Persistent AF | – | Other: Peripheral Blood Sample |
| Paroxysmal AF | – | Other: Peripheral Blood Sample |
| Psoriasis | – | Other: Peripheral Blood Sample |
| Healthy Controls | – | Other: Peripheral Blood Sample |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients 18 years and older.
Key inclusion criteria (3 listed)
- Cases: AF (Persistent, paroxysmal AF)
- Controls 1: (No prior history of AF or inflammatory or autoimmune diseases)
- Controls 2: (biopsy proven Psoriasis)
Key exclusion criteria (12 listed)
- Clinically apparent acute infections over the past 4 weeks
- Chronic infections
- Recent malignancies
- Recent Radiation or chemotherapy
- Chronic kidney disease (≥ stage 2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral Blood Sample30mL peripheral whole blood sample | Other | Healthy Controls, Paroxysmal AF, Persistent AF, Psoriasis |
Primary outcome
Cytokines Levels
Time frame: through study completion, approximately 3 years.
Cytokine Profiles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rowlens M. Melduni, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokines Levels (time frame: through study completion, approximately 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2022.