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Atrial FibrillationNCT05151523

Long-term Recurrence Rates of Atrial Fibrillation Following New-onset Atrial Fibrillation During ICU Admission

An observational study of Atrial Fibrillation, run by Katia Orvin.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The Primary Objective of the study is to establish the One-year recurrence rates of atrial fibrillation (AF) following new-onset atrial fibrillation during intensive care unit (ICU) admission. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
How many people
100 participants
Where
No sites listed yet
Study dates
1 Jan 2022to 1 Dec 2026
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients diagnosed with new-onset atrial-fibriltion using 30-second telemetry recording or a 12 lead ECG indicating AF during general ICU hospitalization.

Who may be able to join

  • Admitted to ICU over 24 hours
  • Diagnosed with new-onset atrial fibrillation
  • The patient survived the index hospitalization and was discharged home/ to a rehabilitation center.

Who cannot join

  • Previously documented atrial fibrillation

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Katia Orvin, M.D contact

+972548001942

katiaorvin@gmail.com

LIOR FISHER, M.D contact

+972547440708

fisherlior1@gmail.com

About this study

The Primary Objective of the study is to establish the One-year recurrence rates of atrial fibrillation (AF) following new-onset atrial fibrillation during intensive care unit (ICU) admission.

The Secondary Objective is a composite of death from cardiovascular causes, stroke (either ischemic or hemorrhagic), or hospitalization with worsening of heart failure or recurrent AF.

The prevalence and recurrence rates of AF will be divided into sub-groups based on primary ICU admission diagnosis.

All-cause mortality.

Read the detailed description

Patients will be screened for atrial fibrillation during hospitalization in the intensive care unit and will be followed until discharge. Once discharged home or to a rehabilitation center, they will be invited to a routine follow-up clinic at RMC cardiology institute 4-6 weeks after hospital discharge. During the clinic visit, patients will be recruited to the study follow-up plan.

The follow-up plan will consist of 3 clinical visits at 4-6 weeks, 6-months and 1 -year after discharge.

The follow-up program will include a comprehensive screening for symptomatic and asymptomatic atrial fibrillation events as following:

Patients will be provided with a home cellular-digital 12-lead ECG transmitter. They will be instructed to conduct routine weekly transmission in order to record asymptomatic events as well as to transmit at any time they suspect an event/feel symptoms (palpitations). Home routine testing will be initiated and guided by a telephone call from a medical monitoring center. A blinded, independent, on-call medical professional team will analyze the received ECG.

A 48-hour Holter ECG will be performed at 6 months and 12 months after ICU discharge

Clinical visits will include 12 leads ECG, physical examination, vital signs, symptoms evaluation for suspected AF events, questioning for hospital admissions, or any other documented AF event. Patients will be asked to perform echocardiography as part of their clinical evaluation. For both the study and control group, documented AF events will be managed according to physician discretion based on clinical practice and guidelines.

Long-term follow-up- 3 years- data regarding recurrent events of AF, hospitalization due to thromboembolic events, and mortality will be evaluated by telephone call or by matching patient identification numbers with the Israeli National Population Register.

Keywords
atrial fibrillation, intensive care unit
Medical subject headings
Atrial Fibrillation

What is being measured

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

  1. Recurrence rates of atrial-fibrillation following new-onset atrial-fibrillation during intensive care unit

    A positive ECG or Holter test for atrial fibrillation will be regarded as recurrence.

    Measured: One-year

Secondary outcomes (3)

  1. Major adverse cardiovascular events

    A composite of death from cardiovascular causes, stroke (either ischemic or hemorrhagic), or hospitalization with worsening of heart failure or recurrent AF.

    Measured: 3-years

  2. Recurrence rates of atrial-fibrillation

    The prevalence and recurrence rates of atrial-fibrillation divided into sub-groups based on primary ICU admission diagnosis.

    Measured: 3-years

  3. All-cause mortality

    All-cause mortality will be monitored on clinical flow-up.

    Measured: 3-years

Timeline

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

  1. First posted9 Dec 2021
  2. Study start1 Jan 2022 (estimated)
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05151523
Sponsor's protocol ID
0318-21-RMC
Status last verified
Dec 2021
First submitted
3 Nov 2021
Last updated
16 Dec 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Boriani G, Fauchier L, Aguinaga L, Beattie JM, Blomstrom Lundqvist C, Cohen A, Dan GA, Genovesi S, Israel C, Joung B, Kalarus Z, Lampert R, Malavasi VL, Mansourati J, Mont L, Potpara T, Thornton A, Lip GYH; ESC Scientific Document Group. European Heart Rhythm Association (EHRA) consensus document on management of arrhythmias and cardiac electronic devices in the critically ill and post-surgery patient, endorsed by Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), Cardiac Arrhythmia Society of Southern Africa (CASSA), and Latin American Heart Rhythm Society (LAHRS). Europace. 2019 Jan 1;21(1):7-8. doi: 10.1093/europace/euy110. No abstract available.

    PubMed 29905786

  • January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; ACC/AHA Task Force Members. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014 Dec 2;130(23):2071-104. doi: 10.1161/CIR.0000000000000040. Epub 2014 Mar 28. No abstract available.

    PubMed 24682348

  • Kanji S, Williamson DR, Yaghchi BM, Albert M, McIntyre L; Canadian Critical Care Trials Group. Epidemiology and management of atrial fibrillation in medical and noncardiac surgical adult intensive care unit patients. J Crit Care. 2012 Jun;27(3):326.e1-8. doi: 10.1016/j.jcrc.2011.10.011. Epub 2012 Jan 4.

    PubMed 22226423

  • McIntyre WF, Um KJ, Cheung CC, Belley-Cote EP, Dingwall O, Devereaux PJ, Wong JA, Conen D, Whitlock RP, Connolly SJ, Seifer CM, Healey JS. Atrial fibrillation detected initially during acute medical illness: A systematic review. Eur Heart J Acute Cardiovasc Care. 2019 Mar;8(2):130-141. doi: 10.1177/2048872618799748. Epub 2018 Nov 7.

    PubMed 30403364

  • Lubitz SA, Yin X, Rienstra M, Schnabel RB, Walkey AJ, Magnani JW, Rahman F, McManus DD, Tadros TM, Levy D, Vasan RS, Larson MG, Ellinor PT, Benjamin EJ. Long-term outcomes of secondary atrial fibrillation in the community: the Framingham Heart Study. Circulation. 2015 May 12;131(19):1648-55. doi: 10.1161/CIRCULATIONAHA.114.014058. Epub 2015 Mar 13.

    PubMed 25769640

  • Walkey AJ, Hammill BG, Curtis LH, Benjamin EJ. Long-term outcomes following development of new-onset atrial fibrillation during sepsis. Chest. 2014 Nov;146(5):1187-1195. doi: 10.1378/chest.14-0003.

    PubMed 24723004

  • Gialdini G, Nearing K, Bhave PD, Bonuccelli U, Iadecola C, Healey JS, Kamel H. Perioperative atrial fibrillation and the long-term risk of ischemic stroke. JAMA. 2014 Aug 13;312(6):616-22. doi: 10.1001/jama.2014.9143.

    PubMed 25117130

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Katia Orvin.

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 1 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: opening soon, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Katia Orvin, M.D (+972548001942, katiaorvin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence rates of atrial-fibrillation following new-onset atrial-fibrillation during intensive care unit (time frame: One-year). 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 NCT05151523, 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 16 Dec 2021.

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