NCT03836339

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,369

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 11, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

May 14, 2021

Status Verified

May 1, 2021

Enrollment Period

1.2 years

First QC Date

January 27, 2019

Last Update Submit

May 13, 2021

Conditions

Keywords

emergency departmentpathway of careassessmentanticoagulants

Outcome Measures

Primary Outcomes (13)

  • 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 Outcomes (19)

  • mortality

    at 24 hours after admission

  • mortality

    at 3 months

  • mortality

    at 6 months

  • mortality

    at 1 year

  • atrial fibrillation incidence

    at 3 months

  • +14 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Atrial fibrillation diagnosis on ECG

You may not qualify if:

  • Refusal of the patient to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucien Hussel Hospital

Vienne, 38209, France

Location

MeSH Terms

Conditions

Atrial FibrillationEmergencies

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Stephane Manzo-Silberman, MD

    French Cardiology Society

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2019

First Posted

February 11, 2019

Study Start

October 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

May 14, 2021

Record last verified: 2021-05

Locations