Long-term Recurrence Rates of Atrial Fibrillation Following New-onset Atrial Fibrillation During ICU Admission
NCT ID: NCT05151523
Last Updated: 2021-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2022-01-01
2026-12-01
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with new-onset atrial fibrillation
* The patient survived the index hospitalization and was discharged home/ to a rehabilitation center.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Katia Orvin
OTHER
Responsible Party
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Katia Orvin
Katia Orvin M.D - director of cardiac intensive care unit, Rabin Medical Center
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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0318-21-RMC
Identifier Type: -
Identifier Source: org_study_id