ATRIAL FIBRILATION OPPORTUNISTIC SCREENING AND STROKE (AFOSS).

Overview

People: The absolute prevalence of undiagnosed atrial fibrillation in individuals over 60 years of age is 2.2%, equivalent to 20.1% of the overall prevalence of AF and there is not sufficient evidence regarding the procedures that may be most effective for achieving an early diagnosis of AF and reducing the associated stroke risks.

Intervention: Characterize the ideal population for searching unknown atrial fibrillation and develop an understanding of actions that could be taken today to improve the diagnosis and management of AF.

C: Compare two large populations with and without opportunistic screening of AF about stroke incidence.

Outcome: MAIN OBJECTIVES

1. Compare two large populations with and without opportunistic screening of AF.

2. Relate the incidence of stroke episode with the AF diagnosis

3. Characterize the ideal population for searching unknown atrial fibrillation by making a multivariate predictor model.

4. Develop an understanding of actions that could be taken today to improve the diagnosis and management of AF.

5. Evaluate whether intervention results in improved outcomes

Full Title of Study: “Atrial Fibrilation Opportunistic Screening and Stroke Incidence (AFOSS): Searching the Unknown Atrial Fibrillation.”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: December 31, 2017

Detailed Description

Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice, and is increasing in both incidence and prevalence. Almost two hundred thousand Catalonian people over 60 year-old currently have AF, and estimates project that between 250.000 and 300.000 will be affected by 2050. Perhaps the most important consequence of AF is the risk of embolic stroke.

It has been estimated that around one in five strokes are attributed to AF overall, and one in three strokes in people over the age of 80 are attributed to AF. AF-related strokes are associated with significant morbidity, mortality and healthcare costs, yet they are highly preventable. Unfortunately, AF is often undiagnosed or untreated when stroke occurs.

In addition, the absolute prevalence of undiagnosed atrial fibrillation in individuals over 60 years of age is 2.2%, equivalent to 20.1% of the overall prevalence of AF. This is higher than in the reports of other studies, which range from 0.49% to 1.7% when diagnosed by means of standard ECG, but lower than the AF incidence (30%) detected by continuous monitoring in patients with risk factors for stroke. The prevalence of AF in the community is probably underestimated, as a consequence of the failure to detect and diagnose it and may be responsible for an additional subset of the 25-40% of strokes of unknown cause. It has been suggested that asymptomatic AF represents a third of the total AF population, a result confirmed in pacemaker studies. Around thirty eight thousand Catalonian people over 60 year-old currently could suffer unknown AF, and consequently non-treated, and estimates project that between 1,350-2,475 stroke/year could be related to this untreated condition.

While the data confirm the evident age-related increase in the prevalence of persistent AF and demonstrate that hypertension is the most frequently associated cardiovascular risk factor together with the presence of cardiovascular disease there is not sufficient evidence regarding the procedures that may be most effective for achieving an early diagnosis of AF and reducing the associated risks. A significant proportion of people with AF are diag¬nosed by chance during health assessments carried out for other reasons, or due to having a stroke. There may be multiple reasons for under-diagnosis, including the fact that AF can be asymptomatic and a lack of awareness about the condition and its symptoms. There is considerable interest in developing AF screening programs

Opportunistic screening, where patients are checked for AF when they visit doctors for other reasons, is widely supported as a means to achieve higher rates of detec¬tion to enable early intervention. Screening for AF anyone >65 years or at high risk of stroke has been recommended by Mention of European Society of Cardiology (ESC), Stroke Alliance for Europe (SAFE), European Heart Rhythm Association (EHRA), Royal College of Physicians of Edinburg (RCPE), World Healthcare Forum (WHF), European Primary Care Cardiovascular Society (EPCCS), Health Information and Quality Authority (HIQA), and AF-SCREEN. Currently, routine mass screenings are not carried out in any countries at a national level. Opportunistic screening was tested against routine screening by the SAFE study, which found that opportunistic screening improved on routine practice and out¬reach campaign in Spain[23] was found to have had little effect on diagnosis of previously undetected AF and it was concluded that opportunistic screening is thus a better strategy for early detection.

It is important to note that, for many patients with AF, the condition is often asymptomatic – or associated with minor symptoms that are ignored or unrecognized by patients – and some type of AF screening is needed. Until the new external devices can be used more widely, ECG combined with reviews of medical history will continue to be the most feasible noninvasive strategy for identifying individuals with AF in epidemiological studies. The key issue, however, is not which test is best for diagnosing AF or how to undertake an effective screening procedure, but it is rather the appropriate measurement of results and achieving optimal effectiveness.

Interventions

  • Diagnostic Test: Opportunistic atrial fibrillation screening
    • Opportunistic pulse palpation and/or ECG at least once a year when they visit doctors or nurse for other reasons.

Arms, Groups and Cohorts

  • People over 60 years of age
    • People over 60 years of age without previous known atrial fibrillation

Clinical Trial Outcome Measures

Primary Measures

  • Atrial fibrillation
    • Time Frame: 01/Jan/2016 to 31/Decemb/2017
    • Atrial fibrillation new diagnosis

Secondary Measures

  • ischaemic stroke
    • Time Frame: 01/jan/2016 to 31/Decemb/2018
    • New ischaemic stroke

Participating in This Clinical Trial

Inclusion Criteria

  • Patients older than 60 years included in the computer program of the ICS (Catalan Institute of Health).

Exclusion Criteria

  • Patients under 60 years old. Deceased

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Jordi Gol i Gurina Foundation
  • Collaborator
    • Jordi Gol Primary Health Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jose Maria Alegret-Colomè, PhD, Study Director, Rovira i Virgili University

Citations Reporting on Results

Panisello-Tafalla A, Clua-Espuny JL, Gil-Guillen VF, González-Henares A, Queralt-Tomas ML, López-Pablo C, Lucas-Noll J, Lechuga-Duran I, Ripolles-Vicente R, Carot-Domenech J, López MG. Results from the Registry of Atrial Fibrillation (AFABE): Gap between Undiagnosed and Registered Atrial Fibrillation in Adults–Ineffectiveness of Oral Anticoagulation Treatment with VKA. Biomed Res Int. 2015;2015:134756. doi: 10.1155/2015/134756. Epub 2015 Jul 1.

Clua-Espuny JL, Lechuga-Duran I, Bosch-Princep R, Roso-Llorach A, Panisello-Tafalla A, Lucas-Noll J, López-Pablo C, Queralt-Tomas L, Giménez-Garcia E, González-Rojas N, Gallofré López M. Prevalence of undiagnosed atrial fibrillation and of that not being treated with anticoagulant drugs: the AFABE study. Rev Esp Cardiol (Engl Ed). 2013 Jul;66(7):545-52. doi: 10.1016/j.rec.2013.03.003. Epub 2013 May 31.

Clua-Espuny JL, Panisello-Tafalla A, Lopez-Pablo C, Lechuga-Duran I, Bosch-Princep R, Lucas-Noll J, Gonzalez-Henares A, Queralt-Tomas L, Ripolles-Vicente R, Calduch-Noll C, Gonzalez-Rojas N, Gallofre-Lopez M. Atrial Fibrillation and Cardiovascular Comorbidities, Survival and Mortality: A Real-Life Observational Study. Cardiol Res. 2014 Feb;5(1):12-22. doi: 10.14740/cr324e. Epub 2014 Feb 27.

Clua-Espuny JL, Piñol-Moreso JL, Gil-Guillén VF, Orozco-Beltrán D, Panisello-Tafalla A, Lucas-Noll J, Queralt-Tomás ML, Pla-Farnós R. [Primary and secondary cardiovascular prevention results in patients with stroke: relapse risk and associated survival (Ebrictus study)]. Rev Neurol. 2012 Jan 16;54(2):81-92. Spanish.

Clua Espuny JL, Dalmau Llorca MR, Aguilar Martín C; Grupo de Trabajo. [Characteristics of oral anti-coagulation treatment in high-risk chronic auricular fibrillation]. Aten Primaria. 2004 Nov 15;34(8):414-9. Spanish.

Giménez-García E, Clua-Espuny JL, Bosch-Príncep R, López-Pablo C, Lechuga-Durán I, Gallofré-López M, Panisello-Tafalla A, Lucas-Noll J, Queralt-Tomas ML. [The management of atrial fibrillation and characteristics of its current care in outpatients. AFABE observational study]. Aten Primaria. 2014 Feb;46(2):58-67. doi: 10.1016/j.aprim.2013.06.003. Epub 2013 Sep 14. Spanish.

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