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Atrial FibrillationACFANCT03836339

Assessment of Atrial Fibrillation in Emergency Department

An observational study of Atrial Fibrillation, run by RESCUe - RESeau Cardiologie Urgence / RESUVal - RESeau des Urgences de la vallée du Rhône at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
How many people
1,369 participants
Where
1 siteFrance
Study dates
1 Oct 2018to 31 Dec 2019
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Atrial fibrillation diagnosis on ECG

Who cannot join

  • Refusal of the patient to participate

Trial locations and contacts

1 site in 1 country.

France1 site

  • Lucien Hussel Hospital

    Vienne, 38209

Other trials in France

About this study

Official title: 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.

Read the 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.

Keywords
emergency department, pathway of care, assessment, anticoagulants
Medical subject headings
Atrial Fibrillation, Emergencies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. atrial fibrillation type

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

    Measured: At admission

  2. Troponin value

    incidence of positive troponin

    Measured: At admission

  3. Brain Natriuretic Peptide (BNP/proBNP) value

    incidence of BNP elevation

    Measured: At admission

  4. 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)

    Measured: At admission

  5. cardiac echography

    number of cardiac echography performed in ED

    Measured: At admission

  6. antiarythmic drugs

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

    Measured: at admission

  7. antiarythmic drugs

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

    Measured: at 3 months

  8. antiarythmic drugs

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

    Measured: at 6 months

  9. antiarythmic drugs

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

    Measured: at 1 year

  10. anticoagulant strategy

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

    Measured: at admission

  11. anticoagulant strategy

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

    Measured: at 3 months, 6 months and 1 year

  12. anticoagulant strategy

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

    Measured: at 6 months and 1 year

  13. anticoagulant strategy

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

    Measured: at 1 year

Secondary outcomes (19)

  1. mortality

    number of dead patients

    Measured: at 24 hours after admission

  2. mortality

    number of dead patients

    Measured: at 3 months

  3. mortality

    number of dead patients

    Measured: at 6 months

  4. mortality

    number of dead patients

    Measured: at 1 year

  5. atrial fibrillation incidence

    number of patients with recurrent and persistent

    Measured: at 3 months

  6. atrial fibrillation incidence

    number of patients with recurrent and persistent

    Measured: at 6 months

  7. atrial fibrillation incidence

    number of patients with recurrent and persistent

    Measured: at 1 year

  8. stroke incidence

    number of new strokes occured

    Measured: at admission

  9. stroke incidence

    number of new strokes occured

    Measured: at 3 months

  10. stroke incidence

    number of new strokes occured

    Measured: at 6 months

  11. stroke incidence

    number of new strokes occured

    Measured: at 1 year

  12. myocardial infarction incidence

    number of new myocardial infarctions occured

    Measured: at admission

  13. myocardial infarction incidence

    number of new myocardial infarctions occured

    Measured: at 3 months

  14. myocardial infarction incidence

    number of new myocardial infarctions occured

    Measured: at 6 months

  15. myocardial infarction incidence

    number of new myocardial infarctions occured

    Measured: at 1 year

  16. hemorrhagic events

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

    Measured: at admission

  17. hemorrhagic events

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

    Measured: at 3 months

  18. hemorrhagic events

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

    Measured: at 6 months

  19. hemorrhagic events

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

    Measured: at 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2019
  2. Study start1 Oct 2018
  3. Primary completion31 Dec 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,369 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT03836339
Sponsor's protocol ID
2018ACFA10-11
Acronym
ACFA
Status last verified
May 2021
First submitted
27 Jan 2019
Last updated
14 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by RESCUe - RESeau Cardiologie Urgence / RESUVal - RESeau des Urgences de la vallée du Rhône at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

atrial fibrillation type (time frame: At admission). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03836339.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021.

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