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

NCT05151523 | Not Yet Recruiting

• 1 other identifier: 0318-21-RMC
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; intensive care unit

Outcome Measures

Primary Outcomes (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.

  One-year

Secondary Outcomes (3)

• Major adverse cardiovascular events

  3-years

• Recurrence rates of atrial-fibrillation

  3-years

• All-cause mortality

  3-years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Previously documented atrial fibrillation

Sponsors & Collaborators

• Katia Orvin: lead

Related Publications (7)

• 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.

  PMID: 29905786 BACKGROUND

• 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.

  PMID: 24682348 BACKGROUND

• 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.

  PMID: 22226423 RESULT

• 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.

  PMID: 30403364 RESULT

• 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.

  PMID: 25769640 RESULT

• 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.

  PMID: 24723004 RESULT

• 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.

  PMID: 25117130 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Katia Orvin, M.D

CONTACT

+972548001942; katiaorvin@gmail.com

LIOR FISHER, M.D

CONTACT

+972547440708; fisherlior1@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Katia Orvin M.D - director of cardiac intensive care unit, Rabin Medical Center

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: December 9, 2021
• Study Start: January 1, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 16, 2021

Record last verified: 2021-12