ATRIAL FIBRILATION OPPORTUNISTIC SCREENING AND STROKE (AFOSS).

NCT03589170 | Unknown DMC

• 1 other identifier: 10-ECO
• Study Type: observational
• Target: 51,410
• Locations: 0 countries
• Sites: N/A

Brief 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 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. 1.Compare two large populations with and without opportunistic screening of AF.
2. 2.Relate the incidence of stroke episode with the AF diagnosis
3. 3.Characterize the ideal population for searching unknown atrial fibrillation by making a multivariate predictor model.
4. 4.Develop an understanding of actions that could be taken today to improve the diagnosis and management of AF.
5. 5.Evaluate whether intervention results in improved outcomes

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Opportunistic screening; ischaemic stroke

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation

  Atrial fibrillation new diagnosis

  01/Jan/2016 to 31/Decemb/2017

Secondary Outcomes (1)

• ischaemic stroke

  01/jan/2016 to 31/Decemb/2018

Study Arms (1)

People over 60 years of age

People over 60 years of age without previous known atrial fibrillation

Diagnostic Test: Opportunistic atrial fibrillation screening

Interventions

Opportunistic atrial fibrillation screening DIAGNOSTIC_TEST

Opportunistic pulse palpation and/or ECG at least once a year when they visit doctors or nurse for other reasons.

Also known as: detection atrial fibrillation, pulse palpation

People over 60 years of age

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients under 60 years old. Deceased

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• University Rovira i Virgili: collaborator
• Catalan Institute of Health: collaborator

Related Publications (6)

• 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.

  PMID: 26229954 RESULT

• Clua-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.

  PMID: 24776203 RESULT

• 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.

  PMID: 28392870 RESULT

• Clua-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.

  PMID: 22234566 RESULT

• Clua 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.

  PMID: 15546539 RESULT

• Gimenez-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.

  PMID: 24042075 RESULT

MeSH Terms

Conditions

Atrial Fibrillation; Ischemic Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Jose Maria Alegret-Colomè, PhD

  University Rovira i Virgili

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: July 17, 2018
• Study Start: January 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2019
• Last Updated: July 17, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: At the end of the study.
• Access Criteria: Applications received to share results will be independently assessed at the end of the study .