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Completed

NCT Number: NCT03836339

Assessment of Atrial Fibrillation in Emergency Department

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Disease Attributes Emergencies Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lucien Hussel Hospital

Vienne, 38209, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Atrial fibrillation diagnosis on ECG

Exclusion criteria

  • Refusal of the patient to participate

Treatment and study plan

Primary outcomes

  1. atrial fibrillation type

    Time frame: At admission

    Number of idiopathic AF, AF secondary to acute heart failure, pulmonary embolism, COPD decompensation, pneumopathy, dysthyroidism, or any other precipitating factor.

  2. Troponin value

    Time frame: At admission

    incidence of positive troponin

  3. Brain Natriuretic Peptide (BNP/proBNP) value

    Time frame: At admission

    incidence of BNP elevation

  4. Renal Clearance

    Time frame: At admission

    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)

  5. cardiac echography

    Time frame: At admission

    number of cardiac echography performed in ED

  6. antiarythmic drugs

    Time frame: at admission

    list antiarythmic drugs administration (Class IA, IB, IC, II, III or IV of Vaughan Williams classification, digitalis or adenosin)

  7. antiarythmic drugs

    Time frame: at 3 months

    list antiarythmic drugs administration (Class IA, IB, IC, II, III or IV of Vaughan Williams classification, digitalis or adenosin)

  8. antiarythmic drugs

    Time frame: at 6 months

    list antiarythmic drugs administration (Class IA, IB, IC, II, III or IV of Vaughan Williams classification, digitalis or adenosin)

  9. antiarythmic drugs

    Time frame: at 1 year

    list antiarythmic drugs administration (Class IA, IB, IC, II, III or IV of Vaughan Williams classification, digitalis or adenosin)

  10. anticoagulant strategy

    Time frame: at admission

    anticoagulant therapy (vitamin K antagonist or direct oral anticoagulant) administration

  11. anticoagulant strategy

    Time frame: at 3 months, 6 months and 1 year

    anticoagulant therapy (vitamin K antagonist or direct oral anticoagulant) administration

  12. anticoagulant strategy

    Time frame: at 6 months and 1 year

    anticoagulant therapy (vitamin K antagonist or direct oral anticoagulant) administration

  13. anticoagulant strategy

    Time frame: at 1 year

    anticoagulant therapy (vitamin K antagonist or direct oral anticoagulant) administration

Secondary outcomes

  1. mortality

    Time frame: at 24 hours after admission

    number of dead patients

  2. mortality

    Time frame: at 3 months

    number of dead patients

  3. mortality

    Time frame: at 6 months

    number of dead patients

  4. mortality

    Time frame: at 1 year

    number of dead patients

  5. atrial fibrillation incidence

    Time frame: at 3 months

    number of patients with recurrent and persistent

  6. atrial fibrillation incidence

    Time frame: at 6 months

    number of patients with recurrent and persistent

  7. atrial fibrillation incidence

    Time frame: at 1 year

    number of patients with recurrent and persistent

  8. stroke incidence

    Time frame: at admission

    number of new strokes occured

  9. stroke incidence

    Time frame: at 3 months

    number of new strokes occured

  10. stroke incidence

    Time frame: at 6 months

    number of new strokes occured

  11. stroke incidence

    Time frame: at 1 year

    number of new strokes occured

  12. myocardial infarction incidence

    Time frame: at admission

    number of new myocardial infarctions occured

  13. myocardial infarction incidence

    Time frame: at 3 months

    number of new myocardial infarctions occured

  14. myocardial infarction incidence

    Time frame: at 6 months

    number of new myocardial infarctions occured

  15. myocardial infarction incidence

    Time frame: at 1 year

    number of new myocardial infarctions occured

  16. hemorrhagic events

    Time frame: at admission

    type 1, 2 or 3 of the International Society on Thrombosis and Hemostasis classification

  17. hemorrhagic events

    Time frame: at 3 months

    type 1, 2 or 3 of the International Society on Thrombosis and Hemostasis classification

  18. hemorrhagic events

    Time frame: at 6 months

    type 1, 2 or 3 of the International Society on Thrombosis and Hemostasis classification

  19. hemorrhagic events

    Time frame: at 1 year

    type 1, 2 or 3 of the International Society on Thrombosis and Hemostasis classification

Sponsors and collaborators

Lead sponsor

RESCUe - RESeau Cardiologie Urgence / RESUVal - RESeau des Urgences de la vallée du Rhône

Other

Collaborators

  • Bayer
  • Boehringer Ingelheim
  • French Cardiology Society
  • French Society of Emergency Medicine

Registry information

Official study title

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

Acronym: ACFA

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 11, 2019
Registry last updated
May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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