Assessment of Atrial Fibrillation in Emergency Department (ACFA)

Appréciation de la Prise en Charge de la Fibrillation Atriale Aux Urgences

Atrial Fibrillation (AF) is the most common disorder of the rhythm disturbance, especially in older adults. The incidence and prevalence of AF increases significantly with age: less than one new case per 1000/year before age 40 to 20/1000 per year after the age of eighty. AF represents 1% of emergency department (ED) visits a third of which are inaugural or recurrent. The causes are varied from cardiac (ischemic cardiac disease, valvular, high blood pressure, heart failure, pericarditis, myocarditis) to extra cardiac etiologies (pulmonary embolism, thyroid disorders, thyrotoxicosis, alcohol, shock, chest trauma, electrolyte disorders, dehydration). While the diagnosis is given quickly by reading the electrocardiogram (ECG), its management both in terms of therapeutic strategy that of choice of care pathway is complex as evidenced by the diversity of possibilities and the difference in practice. Specific recommendations have been published by the French Society of Emergency Medicine in 2015. Our study aims to investigate guidelines implementation in French ED, especially the contribution of diagnostic tests and initiated treatments. Therapeutic strategies are evaluated with a follow up at 3 months, 6 months and 1 year, reporting cardiovascular events and long-term treatment.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation

Detailed Description

This study is non-interventional, recruiting patients presenting to ED with AF. No other epidemiological studies on the subject are available to calculate the required number of subjects and analyze the power of the study. Investigators planned to include 1 575 patients (45 patients in 35 centres) with a minimum targeted 1000 patients to be included in the 30-40 participating centers. The study aims to assess patients characteristics (age, sex, body mass index, type of AF, Congestive Heart failure Hypertension Age Diabetes Stroke - VAscular disease (CHA2DS2- VAsc) Score, Hypertension Abnormal liver/renal function, Stroke history, Bleeding history or predisposition, Labile INR, Elderly, Drug/alcohol usage (HAS-BLED) score), methods of diagnostic (blood tests, ECG, Imaging tests, Cardiac echography), treatment pattern (drugs administered in ED, drug prescribed at hospitalization discharge), patient pathway (orientation after ED admission, discharge, consultation planned), drug-related observance reported by the patient.

Data are collected in a case report form (CRF). Source data verification is performed by sites investigators. A data dictionary containing detailed descriptions of each variable is shared with investigators. Sites monitoring is planned by a clinical research assistant for completing missing data.

Statistical analysis: Data are medians and interquartile ranges (IQRs) for continuous variables, and numbers and percentages for qualitative variables. Stratified analysis of subgroups (age, sex, anticoagulant treatment, examination performed …) will be considered.

• Study Type: Observational
• Enrollment (Actual): 1369

Contacts and Locations

Study Locations

• France
  • Vienne, France, 38209
    • Lucien Hussel Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients over 18 years admitted to the emergency department with an AF diagnosis on ECG

Description

Inclusion Criteria:

• Atrial fibrillation diagnosis on ECG

Exclusion Criteria:

• Refusal of the patient to participate

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
atrial fibrillation type	Number of idiopathic AF, AF secondary to acute heart failure, pulmonary embolism, COPD decompensation, pneumopathy, dysthyroidism, or any other precipitating factor.	At admission
Troponin value	incidence of positive troponin	At admission
Brain Natriuretic Peptide (BNP/proBNP) value	incidence of BNP elevation	At admission
Renal Clearance	Renal clerance(Cl) measuring (by Cockroft formula : Cl(Male) = 1,23 x Weight (kg) x (140 - Age)/Creatinine, Cl(Female) = 1,04 x Weight (kg) x (140 - Age)/Creatinine)	At admission
cardiac echography	number of cardiac echography performed in ED	At admission
antiarythmic drugs	list antiarythmic drugs administration (Class IA, IB, IC, II, III or IV of Vaughan Williams classification, digitalis or adenosin)	at admission
antiarythmic drugs	list antiarythmic drugs administration (Class IA, IB, IC, II, III or IV of Vaughan Williams classification, digitalis or adenosin)	at 3 months
antiarythmic drugs	list antiarythmic drugs administration (Class IA, IB, IC, II, III or IV of Vaughan Williams classification, digitalis or adenosin)	at 6 months
antiarythmic drugs	list antiarythmic drugs administration (Class IA, IB, IC, II, III or IV of Vaughan Williams classification, digitalis or adenosin)	at 1 year
anticoagulant strategy	anticoagulant therapy (vitamin K antagonist or direct oral anticoagulant) administration	at admission
anticoagulant strategy	anticoagulant therapy (vitamin K antagonist or direct oral anticoagulant) administration	at 3 months, 6 months and 1 year
anticoagulant strategy	anticoagulant therapy (vitamin K antagonist or direct oral anticoagulant) administration	at 6 months and 1 year
anticoagulant strategy	anticoagulant therapy (vitamin K antagonist or direct oral anticoagulant) administration	at 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	number of dead patients	at 24 hours after admission
mortality	number of dead patients	at 3 months
mortality	number of dead patients	at 6 months
mortality	number of dead patients	at 1 year
atrial fibrillation incidence	number of patients with recurrent and persistent	at 3 months
atrial fibrillation incidence	number of patients with recurrent and persistent	at 6 months
atrial fibrillation incidence	number of patients with recurrent and persistent	at 1 year
stroke incidence	number of new strokes occured	at admission
stroke incidence	number of new strokes occured	at 3 months
stroke incidence	number of new strokes occured	at 6 months
stroke incidence	number of new strokes occured	at 1 year
myocardial infarction incidence	number of new myocardial infarctions occured	at admission
myocardial infarction incidence	number of new myocardial infarctions occured	at 3 months
myocardial infarction incidence	number of new myocardial infarctions occured	at 6 months
myocardial infarction incidence	number of new myocardial infarctions occured	at 1 year
hemorrhagic events	type 1, 2 or 3 of the International Society on Thrombosis and Hemostasis classification	at admission
hemorrhagic events	type 1, 2 or 3 of the International Society on Thrombosis and Hemostasis classification	at 3 months
hemorrhagic events	type 1, 2 or 3 of the International Society on Thrombosis and Hemostasis classification	at 6 months
hemorrhagic events	type 1, 2 or 3 of the International Society on Thrombosis and Hemostasis classification	at 1 year

Collaborators and Investigators

• Sponsor: RESCUe - RESeau Cardiologie Urgence / RESUVal - RESeau des Urgences de la vallée du Rhône
• Collaborators: Bayer; Boehringer Ingelheim; French Cardiology Society; French Society of Emergency Medicine
• Investigators: Principal Investigator: Stephane Manzo-Silberman, MD, French Cardiology Society

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: January 27, 2019
• First Submitted That Met QC Criteria: February 7, 2019
• First Posted (Actual): February 11, 2019

Study Record Updates

• Last Update Posted (Actual): May 14, 2021
• Last Update Submitted That Met QC Criteria: May 13, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: emergency department; anticoagulants; pathway of care; assessment
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2018ACFA10-11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No