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Atrial Fibrillation New OnsetNCT05818592

Screening for Atrial Fibrillation With Self Pulse Monitoring

A study testing Self-Pulse Monitoring in people with Atrial Fibrillation New Onset, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to determine the efficacy of self-pulse monitoring in detecting atrial fibrillation (AF) in adult patients at increased risk of stroke. The main questions it aims to answer are: Is self-screening an effective modality for diagnosis of AF? Are there clinical differences and outcomes… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Atrial Fibrillation New Onset
What is being tested?
Self-Pulse Monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
526 participants
Where
1 siteUnited States
Study dates
21 Sep 2020to 31 May 2022
Phase
Interventional
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 18 or greater
  • No known history of atrial fibrillation or atrial flutter
  • Access to MyChart
  • CHA2DS2-VASc sore (described below) >/= 2 (male) or >/=3 (female) based on the following criteria:
  • Two points: Age ≥75, prior stroke
  • One point: Age ≥65-74, congestive heart failure, hypertension, diabetes, vascular disease

Who cannot join

  • Prior diagnosis of atrial fibrillation or atrial flutter
  • Unable to consent
  • Currently incarcerated
  • Self-pay/uninsured
  • Taking anticoagulation for other medical conditions than atrial fibrillation or atrial flutter

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of North Carolina, Chapel Hill

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: Screening for Atrial Fibrillation With Self Pulse Monitoring in Patients at Increased Risk of Stroke

The goal of this clinical trial is to determine the efficacy of self-pulse monitoring in detecting atrial fibrillation (AF) in adult patients at increased risk of stroke.

The main questions it aims to answer are:

Read more
  • Is self-screening an effective modality for diagnosis of AF?
  • Are there clinical differences and outcomes for patients who self-screen?

Eligible participants will be randomized to either the intervention group or control group. The control group will continue with usual standard of care. Participants randomized to the intervention group will be asked to:

  • View an online educational video to teach them the appropriate way to manually check their pulse for irregularities.
  • Manually check their pulse for 30 seconds twice daily for 14 days.
  • Patients who screen positive for irregularities will be sent a 14-day wearable cardiac monitor to assess for underlying arrhythmias.

Researchers will compare the intervention group to the control group to see if there are clinical differences and outcomes.

Read the detailed description

Participants will be recruited for this study using MyChart recruiting. Participants meeting inclusion criteria will be invited to participate and can respond "interested" or "decline." Participants who respond interested will complete a brief survey to confirm eligibility prior to consenting. One the participant consents, they will be randomized to the self-pulse check/intervention group or control group.

Being tested
Self-Pulse Monitoring
Keywords
Atrial Fibrillation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-Pulse MonitoringOther

    Participants will manually monitor pulse for irregularities.

Study groups in NCT05818592
Study groupRoleWhat they receive
Self-Pulse Monitoring Intervention GroupExperimentalParticipants view an educational video instructing them on how to manually check their pulse for irregularities. Participants will be instructed to check their pulse for 30 seconds twice daily for 2 weeks.
Receives: Other: Self-Pulse Monitoring
Control Group Standard of CareNo interventionThe control group will continue with usual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants diagnosed with AF in intervention group who screened positive.

    Participants assigned to the intervention group are instructed on how to manually check their pulse to detect irregularities. Those who screen positive for irregularities will be sent a 14-day wearable cardiac monitor to confirm diagnosis of AF. Diagnosis of AF can also be confirmed by electrocardiogram (ECG) at an outpatient clinic visit.

    Measured: 6 weeks

Secondary outcomes (4)

  1. Total number of participants diagnosed with AF

    Participant data will be collected from the electronic health record one year after randomization to assess how many participants from each arm are subsequently diagnosed with AF.

    Measured: 1-year

  2. Amount of time in days to diagnosis of AF from randomization

    Participant data will be collected from the electronic health record one year after randomization to assess how many participants from each arm are subsequently diagnosed with AF. For participants with a diagnosis of AF, the time in days from randomization to diagnosis will be calculated.

    Measured: 1-year

  3. Number of participants prescribed anticoagulation

    Participant data will be collected from the electronic health record one year after randomization to assess how many participants are prescribed anticoagulation medications.

    Measured: 1-year

  4. Number of participants with stroke, transient ischemic attack (TIA), or systemic embolism

    Participant data will be collected from the electronic health record one year after randomization to assess how many participants have a diagnosis of stroke, TIA, or systemic embolism.

    Measured: 1-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2023
  2. Study start21 Sep 2020
  3. Primary completion31 May 2022
  4. Study completion31 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
Eligible participants will be randomized to either the intervention group or control group.
Masking
None (open label)
Enrolment
526 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05818592
Sponsor's protocol ID
19-2254
Status last verified
Apr 2023
First submitted
4 Apr 2023
Last updated
19 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Publications

  • US Preventive Services Task Force; Curry SJ, Krist AH, Owens DK, Barry MJ, Caughey AB, Davidson KW, Doubeni CA, Epling JW Jr, Kemper AR, Kubik M, Landefeld CS, Mangione CM, Silverstein M, Simon MA, Tseng CW, Wong JB. Screening for Atrial Fibrillation With Electrocardiography: US Preventive Services Task Force Recommendation Statement. JAMA. 2018 Aug 7;320(5):478-484. doi: 10.1001/jama.2018.10321.

    PubMed 30088016

  • Yaghi S, Kamel H. Stratifying Stroke Risk in Atrial Fibrillation: Beyond Clinical Risk Scores. Stroke. 2017 Oct;48(10):2665-2670. doi: 10.1161/STROKEAHA.117.017084. Epub 2017 Sep 15. No abstract available.

    PubMed 28916670

  • Freedman B, Camm J, Calkins H, Healey JS, Rosenqvist M, Wang J, Albert CM, Anderson CS, Antoniou S, Benjamin EJ, Boriani G, Brachmann J, Brandes A, Chao TF, Conen D, Engdahl J, Fauchier L, Fitzmaurice DA, Friberg L, Gersh BJ, Gladstone DJ, Glotzer TV, Gwynne K, Hankey GJ, Harbison J, Hillis GS, Hills MT, Kamel H, Kirchhof P, Kowey PR, Krieger D, Lee VWY, Levin LA, Lip GYH, Lobban T, Lowres N, Mairesse GH, Martinez C, Neubeck L, Orchard J, Piccini JP, Poppe K, Potpara TS, Puererfellner H, Rienstra M, Sandhu RK, Schnabel RB, Siu CW, Steinhubl S, Svendsen JH, Svennberg E, Themistoclakis S, Tieleman RG, Turakhia MP, Tveit A, Uittenbogaart SB, Van Gelder IC, Verma A, Wachter R, Yan BP; AF-Screen Collaborators. Screening for Atrial Fibrillation: A Report of the AF-SCREEN International Collaboration. Circulation. 2017 May 9;135(19):1851-1867. doi: 10.1161/CIRCULATIONAHA.116.026693.

    PubMed 28483832

  • Steinhubl SR, Waalen J, Edwards AM, Ariniello LM, Mehta RR, Ebner GS, Carter C, Baca-Motes K, Felicione E, Sarich T, Topol EJ. Effect of a Home-Based Wearable Continuous ECG Monitoring Patch on Detection of Undiagnosed Atrial Fibrillation: The mSToPS Randomized Clinical Trial. JAMA. 2018 Jul 10;320(2):146-155. doi: 10.1001/jama.2018.8102.

    PubMed 29998336

  • Svennberg E, Engdahl J, Al-Khalili F, Friberg L, Frykman V, Rosenqvist M. Mass Screening for Untreated Atrial Fibrillation: The STROKESTOP Study. Circulation. 2015 Jun 23;131(25):2176-84. doi: 10.1161/CIRCULATIONAHA.114.014343. Epub 2015 Apr 24.

    PubMed 25910800

  • Engdahl J, Andersson L, Mirskaya M, Rosenqvist M. Stepwise screening of atrial fibrillation in a 75-year-old population: implications for stroke prevention. Circulation. 2013 Feb 26;127(8):930-7. doi: 10.1161/CIRCULATIONAHA.112.126656. Epub 2013 Jan 23.

    PubMed 23343564

  • Lowres N, Neubeck L, Redfern J, Freedman SB. Screening to identify unknown atrial fibrillation. A systematic review. Thromb Haemost. 2013 Aug;110(2):213-22. doi: 10.1160/TH13-02-0165. Epub 2013 Apr 18.

    PubMed 23595785

Questions about this trial

What is this clinical trial studying?

A study testing Self-Pulse Monitoring in people with Atrial Fibrillation New Onset, run by University of North Carolina, Chapel Hill 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 6 inclusion and 5 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 19 Apr 2023. 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?

Number of participants diagnosed with AF in intervention group who screened positive. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05818592, which also lists 7 linked publications.

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 19 Apr 2023.

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