Atrial FibrillationFAMDAPNCT01291953
Effectiveness of Early Detection of Atrial Fibrillation
A study testing Screening in people with Atrial Fibrillation, run by Hospital Universitario Reina Sofia de Cordoba.
Trial 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 Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Screening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,990 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jun 2015
- Phase
- Interventional
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients that come to his center of health for any motive.
- That give his assent informed to take part in the study.
Who cannot join
- FA previous Diagnosis
About this study
Official title: Effectiveness of Early Detection of Atrial Fibrillation in People 65 Years or More bt Physicians and Nurse in Primary Care
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
- Conditions
- Atrial Fibrillation
- Being tested
- Screening, Control
- Keywords
- atrial fibrillation, screening, prevention, case finding, primary care
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScreeningProcedure or surgery
Also called Asymptomatic patient
Determination of the arterial pulse and if it is arrhythmic, accomplishment of an ECG
ControlProcedure or surgery
Also called Symptomatic patient
Determination of the arterial pulse and if it is arrhythmic, accomplishment of an ECG
| Study group | Role | What they receive |
|---|---|---|
| Screening | Experimental | Opportunist Screening asymptomatic patients. Taking the arterial pulse. Will invite patient to realize an ECG, if pulse is irregular Receives: Procedure: Screening |
| Control | Active comparator | Case finding of patient whith symptoms of atrial fibrilation. Taking the arterial pulse. ECG if pulse is irregular Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,990 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Reina Sofia de Cordoba
- Sponsor type
- Other government
- Collaborators
- Spanish Society of Family and Community Medicine
- Responsible party
- Principal investigator, Luis A Perula, Hospital Universitario Reina Sofia de Cordoba
- Investigators
- Luis A Perula, PhD, Principal investigator, Andalusian Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291953
- Sponsor's protocol ID
- PI-0419-2010
- Acronym
- FAMDAP
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2011
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28196583Perula-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.
PubMed 23130754
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Early Detection of Atrial Fibrillation in People 65 Years or More bt Physicians and Nurse in Primary Care
- ClinicalTrials.gov ID
- NCT01291953
- Acronym / sponsor ID
- FAMDAP / PI-0419-2010
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, screening, prevention, case finding, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,990 participants (actual)
- Lead sponsor
- Hospital Universitario Reina Sofia de CordobaOther government
- Collaborators
- Spanish Society of Family and Community Medicine
- Study start
- Jan 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 Feb 2011 (estimated)
- 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.
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
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screening | Experimental | Procedure: ScreeningOpportunist Screening asymptomatic patients. Taking the arterial pulse. Will invite patient to realize an ECG, if pulse is irregular |
| Control | Active comparator | Procedure: ControlCase finding of patient whith symptoms of atrial fibrilation. Taking the arterial pulse. ECG if pulse is irregular |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients that come to his center of health for any motive.
Key exclusion criteria (1 listed)
- FA previous Diagnosis
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 |
|---|---|---|
| ScreeningAlso: Asymptomatic patientDetermination of the arterial pulse and if it is arrhythmic, accomplishment of an ECG | Procedure or surgery | Screening |
| ControlAlso: Symptomatic patientDetermination of the arterial pulse and if it is arrhythmic, accomplishment of an ECG | Procedure or surgery | Control |
Primary outcome
efficacy of screening: number of cases diagnosed of Atrial fibrillation (AF)
Time frame: one year
Risk Relative (RR)=number of cases of AF with the Screening/number of cases of AF with the habitual intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Derived from this study: PubMed 28196583Gonzalez 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.
- Derived from this study: PubMed 23130754Perula-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.
- Study protocolLink provided by the sponsor.
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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.
Luis A Perula, PhD principal investigator
Andalusian Health Service
Questions about this trial
What is this clinical trial studying?
A study testing Screening in people with Atrial Fibrillation, run by Hospital Universitario Reina Sofia de Cordoba.
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 2 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: finished, as of the sponsor's last update on 5 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
efficacy of screening: number of cases diagnosed of Atrial fibrillation (AF) (time frame: one year). 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 NCT01291953, which also lists 2 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 5 Feb 2024.