Clinical trial NCT03836339: Assessment of Atrial Fibrillation in Emergency Department
Official title: Appréciation de la Prise en Charge de la Fibrillation Atriale Aux Urgences
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: emergency department
pathway of care
assessment
anticoagulants
Lead sponsor: RESCUe - RESeau Cardiologie Urgence / RESUVal - RESeau des Urgences de la vallée du Rhône
Sponsor class: OTHER
Collaborators: name: French Cardiology Society
name: French Society of Emergency Medicine
name: Bayer
name: Boehringer Ingelheim
First posted: 2019-02-11
Enrollment: 1369
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients over 18 years admitted to the emergency department with an AF diagnosis on ECG

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Atrial fibrillation diagnosis on ECG

Exclusion Criteria:

* Refusal of the patient to participate

Primary outcomes:
measure: atrial fibrillation type
timeFrame: At admission
measure: Troponin value
timeFrame: At admission
measure: Brain Natriuretic Peptide (BNP/proBNP) value
timeFrame: At admission
measure: Renal Clearance
timeFrame: At admission
measure: cardiac echography
timeFrame: At admission
measure: antiarythmic drugs
timeFrame: at admission
measure: antiarythmic drugs
timeFrame: at 3 months
measure: antiarythmic drugs
timeFrame: at 6 months
measure: antiarythmic drugs
timeFrame: at 1 year
measure: anticoagulant strategy
timeFrame: at admission
measure: anticoagulant strategy
timeFrame: at 3 months, 6 months and 1 year
measure: anticoagulant strategy
timeFrame: at 6 months and 1 year
measure: anticoagulant strategy
timeFrame: at 1 year
Secondary outcomes:
measure: mortality
timeFrame: at 24 hours after admission
measure: mortality
timeFrame: at 3 months
measure: mortality
timeFrame: at 6 months
measure: mortality
timeFrame: at 1 year
measure: atrial fibrillation incidence
timeFrame: at 3 months
measure: atrial fibrillation incidence
timeFrame: at 6 months
measure: atrial fibrillation incidence
timeFrame: at 1 year
measure: stroke incidence
timeFrame: at admission
measure: stroke incidence
timeFrame: at 3 months
measure: stroke incidence
timeFrame: at 6 months
measure: stroke incidence
timeFrame: at 1 year
measure: myocardial infarction incidence
timeFrame: at admission
measure: myocardial infarction incidence
timeFrame: at 3 months
measure: myocardial infarction incidence
timeFrame: at 6 months
measure: myocardial infarction incidence
timeFrame: at 1 year
measure: hemorrhagic events
timeFrame: at admission
measure: hemorrhagic events
timeFrame: at 3 months
measure: hemorrhagic events
timeFrame: at 6 months
measure: hemorrhagic events
timeFrame: at 1 year
Other outcomes:
Locations:
city: Vienne
country: France
facility: Lucien Hussel Hospital
Study officials:
affiliation: French Cardiology Society
name: Stephane Manzo-Silberman, MD
role: PRINCIPAL_INVESTIGATOR
References: