ATRIAL FIBRILATION OPPORTUNISTIC SCREENING AND STROKE (AFOSS). (AFOSS)

July 5, 2018 updated by: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Atrial Fibrilation Opportunistic Screening and Stroke Incidence (AFOSS): Searching the Unknown Atrial Fibrillation.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

51410

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients over 60 years of age who have a medical history in the ICS (Catalan Institute of Health) in the Terres de l'Ebre region, Tarragona, Spain.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
People over 60 years of age
People over 60 years of age without previous known atrial fibrillation
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.
Other Names:
  • detection atrial fibrillation
  • pulse palpation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrial fibrillation
Time Frame: 01/Jan/2016 to 31/Decemb/2017
Atrial fibrillation new diagnosis
01/Jan/2016 to 31/Decemb/2017

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ischaemic stroke
Time Frame: 01/jan/2016 to 31/Decemb/2018
New ischaemic stroke
01/jan/2016 to 31/Decemb/2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Collaborators

Catalan Institute of Health
University Rovira i Virgili
Jordi Gol Primary Health Research Institute

Investigators

  • Study Director: Jose Maria Alegret-Colomè, PhD, University Rovira i Virgili

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

December 31, 2017

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

July 5, 2018

First Submitted That Met QC Criteria

July 5, 2018

First Posted (Actual)

July 17, 2018

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 5, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-ECO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will share information about our study at the end of the study if if they are valued positively.

IPD Sharing Time Frame

At the end of the study.

IPD Sharing Access Criteria

Applications received to share results will be independently assessed at the end of the study .

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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