Atrial FibrillationAFOSSNCT03589170
ATRIAL FIBRILATION OPPORTUNISTIC SCREENING AND STROKE (AFOSS).
An observational study of Atrial Fibrillation, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Opportunistic atrial fibrillation screening
- How many people
- 51,410 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2019
- How long will I take part?
- 3 Years
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients older than 60 years included in the computer program of the ICS (Catalan Institute of Health).
Who cannot join
- Patients under 60 years old. Deceased
About this study
Official title: 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.
Read more
C: Compare two large populations with and without opportunistic screening of AF about stroke incidence.
Outcome: MAIN OBJECTIVES
- Compare two large populations with and without opportunistic screening of AF.
- Relate the incidence of stroke episode with the AF diagnosis
- Characterize the ideal population for searching unknown atrial fibrillation by making a multivariate predictor model.
- Develop an understanding of actions that could be taken today to improve the diagnosis and management of AF.
- Evaluate whether intervention results in improved outcomes
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Opportunistic atrial fibrillation screening
- Keywords
- Atrial fibrillation, Opportunistic screening, ischaemic stroke
- Medical subject headings
- Atrial Fibrillation, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opportunistic atrial fibrillation screeningDiagnostic test
Also called detection atrial fibrillation, pulse palpation
Opportunistic pulse palpation and/or ECG at least once a year when they visit doctors or nurse for other reasons.
| Study group | Role | What they receive |
|---|---|---|
| People over 60 years of age | People over 60 years of age without previous known atrial fibrillation Receives: Diagnostic Test: Opportunistic atrial fibrillation screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation
Atrial fibrillation new diagnosis
Measured: 01/Jan/2016 to 31/Decemb/2017
Secondary outcomes (1)
ischaemic stroke
New ischaemic stroke
Measured: 01/jan/2016 to 31/Decemb/2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start1 Jan 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 51,410 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- University Rovira i Virgili, Catalan Institute of Health
- Responsible party
- Sponsor
- Investigators
- Jose Maria Alegret-Colomè, PhD, Study director, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589170
- Sponsor's protocol ID
- 10-ECO
- Acronym
- AFOSS
- Status last verified
- Jul 2018
- First submitted
- 5 Jul 2018
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share information about our study at the end of the study if if they are valued positively.
Publications
Panisello-Tafalla A, Clua-Espuny JL, Gil-Guillen VF, Gonzalez-Henares A, Queralt-Tomas ML, Lopez-Pablo C, Lucas-Noll J, Lechuga-Duran I, Ripolles-Vicente R, Carot-Domenech J, Lopez 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.
PubMed 26229954Clua-Espuny JL, Lechuga-Duran I, Bosch-Princep R, Roso-Llorach A, Panisello-Tafalla A, Lucas-Noll J, Lopez-Pablo C, Queralt-Tomas L, Gimenez-Garcia E, Gonzalez-Rojas N, Gallofre Lopez 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.
PubMed 24776203Clua-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.
PubMed 28392870Clua-Espuny JL, Pinol-Moreso JL, Gil-Guillen VF, Orozco-Beltran D, Panisello-Tafalla A, Lucas-Noll J, Queralt-Tomas ML, Pla-Farnos 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.
PubMed 22234566Clua Espuny JL, Dalmau Llorca MR, Aguilar Martin 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. doi: 10.1016/s0212-6567(04)78925-8. Spanish.
PubMed 15546539Gimenez-Garcia E, Clua-Espuny JL, Bosch-Princep R, Lopez-Pablo C, Lechuga-Duran I, Gallofre-Lopez 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.
PubMed 24042075
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrilation Opportunistic Screening and Stroke Incidence (AFOSS): Searching the Unknown Atrial Fibrillation.
- ClinicalTrials.gov ID
- NCT03589170
- Acronym / sponsor ID
- AFOSS / 10-ECO
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Opportunistic screening, ischaemic stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 51,410 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- University Rovira i Virgili, Catalan Institute of Health
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 17 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Compare two large populations with and without opportunistic screening of AF.
- Relate the incidence of stroke episode with the AF diagnosis
- Characterize the ideal population for searching unknown atrial fibrillation by making a multivariate predictor model.
- Develop an understanding of actions that could be taken today to improve the diagnosis and management of AF.
- Evaluate whether intervention results in improved outcomes
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People over 60 years of age | – | Diagnostic Test: Opportunistic atrial fibrillation screeningPeople over 60 years of age without previous known atrial fibrillation |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients older than 60 years included in the computer program of the ICS (Catalan Institute of Health).
Key exclusion criteria (1 listed)
- Patients under 60 years old. Deceased
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opportunistic atrial fibrillation screeningAlso: detection atrial fibrillation, pulse palpationOpportunistic pulse palpation and/or ECG at least once a year when they visit doctors or nurse for other reasons. | Diagnostic test | People over 60 years of age |
Primary outcome
Atrial fibrillation
Time frame: 01/Jan/2016 to 31/Decemb/2017
Atrial fibrillation new diagnosis
1 secondary outcome
ischaemic stroke
Time frame: 01/jan/2016 to 31/Decemb/2018
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Results publication: PubMed 26229954Panisello-Tafalla A, Clua-Espuny JL, Gil-Guillen VF, Gonzalez-Henares A, Queralt-Tomas ML, Lopez-Pablo C, Lucas-Noll J, Lechuga-Duran I, Ripolles-Vicente R, Carot-Domenech J, Lopez 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.
- Results publication: PubMed 24776203Clua-Espuny JL, Lechuga-Duran I, Bosch-Princep R, Roso-Llorach A, Panisello-Tafalla A, Lucas-Noll J, Lopez-Pablo C, Queralt-Tomas L, Gimenez-Garcia E, Gonzalez-Rojas N, Gallofre Lopez 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.
- Results publication: PubMed 28392870Clua-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.
- Results publication: PubMed 22234566Clua-Espuny JL, Pinol-Moreso JL, Gil-Guillen VF, Orozco-Beltran D, Panisello-Tafalla A, Lucas-Noll J, Queralt-Tomas ML, Pla-Farnos 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.
- Results publication: PubMed 15546539Clua Espuny JL, Dalmau Llorca MR, Aguilar Martin 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. doi: 10.1016/s0212-6567(04)78925-8. Spanish.
- Results publication: PubMed 24042075Gimenez-Garcia E, Clua-Espuny JL, Bosch-Princep R, Lopez-Pablo C, Lechuga-Duran I, Gallofre-Lopez 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.
- Individual participant dataSharing planned: Yes. We will share information about our study at the end of the study if if they are valued positively.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Maria Alegret-Colomè, PhD study director
University Rovira i Virgili
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.
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: status not confirmed, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 (time frame: 01/Jan/2016 to 31/Decemb/2017). 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 NCT03589170, which also lists 6 linked publications.
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 17 Jul 2018.