NCT01291953

Brief Summary

To verify if the screening opportunistic of Atrial Fibrillation (AF) by means of the measurement of the arterial peripheral pulse is more effective than the habitual practice for the early detection of AF in 65-year-old who come to Primary care

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,990

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable atrial-fibrillation

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

4.4 years

First QC Date

February 8, 2011

Last Update Submit

February 2, 2024

Conditions

Keywords

atrial fibrillationscreeningpreventioncase findingprimary care

Outcome Measures

Primary Outcomes (1)

  • efficacy of screening: number of cases diagnosed of Atrial fibrillation (AF)

    Risk Relative (RR)=number of cases of AF with the Screening/number of cases of AF with the habitual intervention

    one year

Study Arms (2)

Screening

EXPERIMENTAL

Opportunist Screening asymptomatic patients. Taking the arterial pulse. Will invite patient to realize an ECG, if pulse is irregular

Procedure: Screening

Control

ACTIVE COMPARATOR

Case finding of patient whith symptoms of atrial fibrilation. Taking the arterial pulse. ECG if pulse is irregular

Procedure: Control

Interventions

ScreeningPROCEDURE

Determination of the arterial pulse and if it is arrhythmic, accomplishment of an ECG

Also known as: Asymptomatic patient
Screening
ControlPROCEDURE

Determination of the arterial pulse and if it is arrhythmic, accomplishment of an ECG

Also known as: Symptomatic patient
Control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients that come to his center of health for any motive.
  • That give his assent informed to take part in the study.

You may not qualify if:

  • FA previous Diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Gonzalez Blanco V, Perula de Torres LA, Martin Rioboo E, Martinez Adell MA, Parras Rejano JM, Gonzalez Lama J, Ruiz Moruno J, Martin Alvarez R, Fernandez Garcia JA, Ruiz de Castroviejo J, Roldan Villalobos A, Ruiz Moral R; grupo de estudio colaborativo DOFA-AP. Opportunistic screening for atrial fibrillation versus detecting symptomatic patients aged 65 years and older: A cluster-controlled clinical trial. Med Clin (Barc). 2017 Jan 6;148(1):8-15. doi: 10.1016/j.medcli.2016.07.036. Epub 2016 Oct 26. English, Spanish.

  • Perula-de-Torres LA, Martinez-Adell MA, Gonzalez-Blanco V, Baena-Diez JM, Martin-Rioboo E, Parras-Rejano JM, Gonzalez-Lama J, Martin-Alvarez R, Ruiz-Moral R, Fernandez-Garcia JA, Perez-Diaz M, Ruiz-de-Castroviejo J, Perula-de-Torres C, Valero-Martin A, Roldan-Villalobos A, Criado-Larumbe M, Burdoy-Joaquin E, Coma-Sole M, Cervera-Leon M, Cuixart-Costa L; Collaborative Group DOFA-AP. Opportunistic detection of atrial fibrillation in subjects aged 65 years or older in primare care: a randomised clinical trial of efficacy. DOFA-AP study protocol. BMC Fam Pract. 2012 Oct 30;13:106. doi: 10.1186/1471-2296-13-106.

Related Links

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Luis A Perula, PhD

    Andalusian Health Service

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Responsible GIEAP

Study Record Dates

First Submitted

February 8, 2011

First Posted

February 9, 2011

Study Start

January 1, 2011

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

February 5, 2024

Record last verified: 2024-02