Assessment of Atrial Fibrillation in Emergency Department

Atrial Fibrillation Clinical Trial

— ACFA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03836339
• Other study ID #: 2018ACFA10-11
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2021
• Source: RESCUe - RESeau Cardiologie Urgence / RESUVal - RESeau des Urgences de la vallée du Rhône
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1369
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Atrial fibrillation diagnosis on ECG

Exclusion Criteria:

• Refusal of the patient to participate

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
France	Lucien Hussel Hospital	Vienne

Sponsors (5)

Lead Sponsor	Collaborator
RESCUe - RESeau Cardiologie Urgence / RESUVal - RESeau des Urgences de la vallée du Rhône	Bayer, Boehringer Ingelheim, French Cardiology Society, French Society of Emergency Medicine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Troponin value	incidence of positive troponin	At admission
Primary	Brain Natriuretic Peptide (BNP/proBNP) value	incidence of BNP elevation	At admission
Primary	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
Primary	cardiac echography	number of cardiac echography performed in ED	At admission
Primary	antiarythmic drugs	list antiarythmic drugs administration (Class IA, IB, IC, II, III or IV of Vaughan Williams classification, digitalis or adenosin)	at admission
Primary	antiarythmic drugs	list antiarythmic drugs administration (Class IA, IB, IC, II, III or IV of Vaughan Williams classification, digitalis or adenosin)	at 3 months
Primary	antiarythmic drugs	list antiarythmic drugs administration (Class IA, IB, IC, II, III or IV of Vaughan Williams classification, digitalis or adenosin)	at 6 months
Primary	antiarythmic drugs	list antiarythmic drugs administration (Class IA, IB, IC, II, III or IV of Vaughan Williams classification, digitalis or adenosin)	at 1 year
Primary	anticoagulant strategy	anticoagulant therapy (vitamin K antagonist or direct oral anticoagulant) administration	at admission
Primary	anticoagulant strategy	anticoagulant therapy (vitamin K antagonist or direct oral anticoagulant) administration	at 3 months, 6 months and 1 year
Primary	anticoagulant strategy	anticoagulant therapy (vitamin K antagonist or direct oral anticoagulant) administration	at 6 months and 1 year
Primary	anticoagulant strategy	anticoagulant therapy (vitamin K antagonist or direct oral anticoagulant) administration	at 1 year
Secondary	mortality	number of dead patients	at 24 hours after admission
Secondary	mortality	number of dead patients	at 3 months
Secondary	mortality	number of dead patients	at 6 months
Secondary	mortality	number of dead patients	at 1 year
Secondary	atrial fibrillation incidence	number of patients with recurrent and persistent	at 3 months
Secondary	atrial fibrillation incidence	number of patients with recurrent and persistent	at 6 months
Secondary	atrial fibrillation incidence	number of patients with recurrent and persistent	at 1 year
Secondary	stroke incidence	number of new strokes occured	at admission
Secondary	stroke incidence	number of new strokes occured	at 3 months
Secondary	stroke incidence	number of new strokes occured	at 6 months
Secondary	stroke incidence	number of new strokes occured	at 1 year
Secondary	myocardial infarction incidence	number of new myocardial infarctions occured	at admission
Secondary	myocardial infarction incidence	number of new myocardial infarctions occured	at 3 months
Secondary	myocardial infarction incidence	number of new myocardial infarctions occured	at 6 months
Secondary	myocardial infarction incidence	number of new myocardial infarctions occured	at 1 year
Secondary	hemorrhagic events	type 1, 2 or 3 of the International Society on Thrombosis and Hemostasis classification	at admission
Secondary	hemorrhagic events	type 1, 2 or 3 of the International Society on Thrombosis and Hemostasis classification	at 3 months
Secondary	hemorrhagic events	type 1, 2 or 3 of the International Society on Thrombosis and Hemostasis classification	at 6 months
Secondary	hemorrhagic events	type 1, 2 or 3 of the International Society on Thrombosis and Hemostasis classification	at 1 year