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Assessment of Atrial Fibrillation in Emergency Department (ACFA)

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ClinicalTrials.gov Identifier: NCT03836339
Recruitment Status : Completed
First Posted : February 11, 2019
Last Update Posted : May 14, 2021
Sponsor:
Collaborators:
French Cardiology Society
French Society of Emergency Medicine
Bayer
Boehringer Ingelheim
Information provided by (Responsible Party):
RESCUe - RESeau Cardiologie Urgence / RESUVal - RESeau des Urgences de la vallée du Rhône

Study Description
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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.

Condition or disease
Atrial Fibrillation

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.

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 1369 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Appréciation de la Prise en Charge de la Fibrillation Atriale Aux Urgences
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients over 18 years admitted to the emergency department with an AF diagnosis on ECG
Criteria

Inclusion Criteria:

  • Atrial fibrillation diagnosis on ECG

Exclusion Criteria:

  • Refusal of the patient to participate
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03836339


Locations
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France
Lucien Hussel Hospital
Vienne, France, 38209
Sponsors and Collaborators
RESCUe - RESeau Cardiologie Urgence / RESUVal - RESeau des Urgences de la vallée du Rhône
French Cardiology Society
French Society of Emergency Medicine
Bayer
Boehringer Ingelheim
Investigators
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Principal Investigator: Stephane Manzo-Silberman, MD French Cardiology Society
More Information
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Additional Information:

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Responsible Party: RESCUe - RESeau Cardiologie Urgence / RESUVal - RESeau des Urgences de la vallée du Rhône
ClinicalTrials.gov Identifier: NCT03836339    
Other Study ID Numbers: 2018ACFA10-11
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: May 14, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RESCUe - RESeau Cardiologie Urgence / RESUVal - RESeau des Urgences de la vallée du Rhône:
emergency department
pathway of care
assessment
anticoagulants
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes