Atrial FibrillationPREFA-TENCT05772806
Diagnostic Approach of Early Atrial Fibrillation, Silent Stroke and Cognitive Disorder in Patients With High-risk
An observational study of Atrial Fibrillation and Atrial Fibrillation New Onset, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
The goal of this observational study is to determine the impact of the combined use of cardiac rhythm recording devices, biomarkers, echocardiogram, and Magnetic Resonance Imaging (MRI) on the early detection of AF, silent stroke, and cognitive impairment in subjects older than 65 years at high risk. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Atrial Fibrillation, Atrial Fibrillation New Onset, Dementia
- What is being tested?
- Electrocardiogram
- Type of treatment
- Medical device
- How many people
- 148 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2023to Dec 2024
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients between 65-85 years old at high risk of AF will be recruited from the usual consultations in six Primary Health Care Centers (PHCC) managed by the Catalan Health Institute (ICS), two in Tarragonés county and four in Terres de l'Ebre county , both situated in Tarragona (South Catalonia, Spain).
Who may be able to join
- Patients between 65-85 years old
- Patients in Q4 (highest risk) of Atrial Fibrillation (AF). [Clua-Espuny et al, 2020]
- CHADsVASc ≥ 2
- Being capable of using a Smart phone (or the care giver)
Who cannot join
- Patients with previous diagnostic of AF, stroke, or dementia.
- Patients treated with anticoagulants.
- Vital prognosis less than one year.
- Severe cognitive or functional impairment (GDS ≥ 3, and/or Barthel score ≤60, or MRS Rankin ≥4, or severe mobility impairment)
- Pacemaker Carrier
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Eva Maria Satue Gracia
Tarragona, 43004
Francisco Manuel Martin Lujan, Medicine, 0034977778515 ext. 405, fmartin.tgn.ics@gencat.cat
Josep Lluís Clua Espuny, Medicine, PhD
About this study
Official title: Diagnostic Approach of Early Atrial Fibrillation, Silent Stroke and Cognitive Disorder in Patients With High-risk: Multicenter, Prospective Cohort Study
The goal of this observational study is to determine the impact of the combined use of cardiac rhythm recording devices, biomarkers, echocardiogram, and Magnetic Resonance Imaging (MRI) on the early detection of AF, silent stroke, and cognitive impairment in subjects older than 65 years at high risk.
The main questions it aims to answer are:
- The early detection of AF, allowing the establishment of preventive measures, will avoid its main complications, especially strokes and cognitive impairment or dementia, in patients at high risk?
- Will cardiac rhythm monitoring devices be useful in the early detection of AF in patients at high risk? Participants will undertake an initial evaluation through an echocardiogram (to detect atrial dysfunction), cranial MRI (to detect silent strokes), plasma/serum collection to determine biomarkers, and a complete clinical assessment (including electrocardiogram, and scales for measurement of cognitive and functional status). The clinical evaluation will be repeated every 6 months and will allow the recording of the date of occurrence of the study events. In addition, annually, patients will be subjected to cardiac rhythm monitoring by electronic devices with the aim of improving AF detection.
Read the detailed description
Design: Multicenter, prospective cohort study Setting and study population: Patients will be recruited from the usual consultations in six Primary Health Care Centers (PHCC) managed by the Catalan Health Institute (ICS), two in Tarragonés county and four in Terres de l'Ebre county, both situated in Tarragona (South Catalonia, Spain).
Study subjects: Patients between 65-85 years old at high risk of FA who are attended at study' PHCCs, consent to participate, and meet inclusion criteria.
Follow-up: Initially all included patients will undertake echocardiography, biomarkers, and cranial /brain Magnetic resonance imaging (MRI). Cardiac monitoring (for 14 days) with two different electronic devices will be performed once every year during the study period. Every six-month electrocardiogram and complete clinical assessment will be done to register risk factors and comorbidities, new cardiovascular events, anthropometric parameters (arterial pressure, heart rate…), and scores at different tests related to functional status (Barthel or Rankin), cognitive function (Global Deterioration Scale [GBS], Mini-Mental State Examination [MMSE]), or AF / stroke risk (CHADsVASc, HAS-BLED). Any changes in the electronic prescription made by the professional according to the patient's assessment will also be recorded.
Data recording: Most of the study data will be recorded from evaluations/tests performed on patients (from anamnesis -including scales-, physical examination, and laboratory tests) or reports provided by specialists (available at computerized clinical history [e-SAP]), in the case of echocardiography (cardiologist) or MRI (radiologist) searching especially atrial dysfunction and signs of silent strokes. Data registered in the electronic primary care health records (e-CAP) of participants will also be collected. Therapeutic (pharmacological) changes will be registered from the SIRE (Catalan acronym for Integrated Electronic Prescription System). Finally, cardiac monitoring data will be collected through the electronic devices' registers. An ad hoc data collection questionnaire will be created to register and store all study variables. The electronic questionnaire will be available at a specific application (where data will remain stored for five years) accessible from the corporate (ICS) Intranet; only study researchers, through personal passwords, may record and access data.
Definition of the outcome variable: Time until the diagnosis of atrial fibrillation (confirmed by electrocardiogram), stroke (new diagnosis in e-CAP or confirmed by neuroimaging) , and cognitive impairment/dementia [diagnosed through Score in Global Deterioration Scale (GDS)].
Sample calculation: To detect a difference of 0.1 units in the prevalence of atrial fibrillation observed, compared to the reference (0.07) accepting an alpha risk of 0.05 and a beta risk of 0.05 a sample of 148 individuals will be required. Estimated loss rate at 15 per cent.
- Conditions
- Atrial Fibrillation, Atrial Fibrillation New Onset, Dementia, Stroke
- Being tested
- Electrocardiogram
- Keywords
- Atrial Fibrillation, Dementia, Stroke
- Medical subject headings
- Atrial Fibrillation, Dementia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrocardiogramDevice
Also called echocardiography, MRI, Smart Bracelet/watch, Fibricheck
The electrocardiogram will help to diagnose atrial fibrillation and the electronic devices (App Fibricheck and Smart bracelet/watch) will help to detect an arrhythmic rhythm.
The echocardiography will be used for detecting criteria of atrial cardiomyopathy.
MRI may help to detect silent strokes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial Fibrillation
New diagnoses of atrial fibrillation could be made during protocolized evaluations every six months (including electrocardiography) or at any time during the study period, provided that an electrocardiogram is performed on the participant, on suspicion of arrhythmia or for any other reason.
Moreover, a search for new-onset atrial fibrillation will be undertaken for 14 days twice during the study period, through cardiac monitoring with smart bracelets (constant monitoring) and using the FibriCheck application (two times a day and in case of symptoms). All new AF diagnoses will require confirmation via 12-lead electrocardiogram
Measured: Through study completion, an average of 2 years
Stroke
Silent strokes may be detected through cranial MRI at initial evaluation. During the study period new stroke diagnoses will require confirmation through a neuroimaging test or neurologist assessment.
Measured: Through study completion, an average of 2 years
Cognitive impairment/ Dementia
Cognitive impairment will be assessed through changes in the Global Deterioration Scale (GDS) score; scores from four will be considered diagnoses of dementia. This diagnosis will also be considered if confirmed through the neurologist's evaluation.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start15 Jan 2023
- Primary completionSep 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Català de la Salut
- Responsible party
- Sponsor
- Investigators
- Josep Lluís Clua-Espuny, MD PhD, Principal investigator, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaEva Maria Satue-Gracia, MD PhD, Study director, Institut Català de la SalutFrancisco M. Martín-Luján, MD PhD, Study director, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772806
- Sponsor's protocol ID
- SLT/21/000027
- Acronym
- PREFA-TE
- Status last verified
- Dec 2022
- First submitted
- 22 Feb 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: not yet decided as future studies are being considered and may be considered
Publications
Hernandez-Pinilla A, Clua-Espuny JL, Satue-Gracia EM, Palleja-Millan M, Martin-Lujan FM; PREFA-TE Study-Group. Protocol for a multicentre and prospective follow-up cohort study of early detection of atrial fibrillation, silent stroke and cognitive impairment in high-risk primary care patients: the PREFA-TE study. BMJ Open. 2024 Feb 19;14(2):e080736. doi: 10.1136/bmjopen-2023-080736.
PubMed 38373864
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Approach of Early Atrial Fibrillation, Silent Stroke and Cognitive Disorder in Patients With High-risk: Multicenter, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05772806
- Acronym / sponsor ID
- PREFA-TE / SLT/21/000027
- Conditions
- Atrial Fibrillation, Atrial Fibrillation New Onset, Dementia, Stroke
- Keywords
- Atrial Fibrillation, Dementia, Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Institut Català de la Salut
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 16 Mar 2023 (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.
The goal of this observational study is to determine the impact of the combined use of cardiac rhythm recording devices, biomarkers, echocardiogram, and Magnetic Resonance Imaging (MRI) on the early detection of AF, silent stroke, and cognitive impairment in subjects older than 65 years at high risk.
The main questions it aims to answer are:
- The early detection of AF, allowing the establishment of preventive measures, will avoid its main complications, especially strokes and cognitive impairment or dementia, in patients at high risk?
- Will cardiac rhythm monitoring devices be useful in the early detection of AF in patients at high risk? Participants will undertake an initial evaluation through an echocardiogram (to detect atrial dysfunction), cranial MRI (to detect silent strokes), plasma/serum collection to determine biomarkers, and a complete clinical assessment (including electrocardiogram, and scales for measurement of cognitive and functional status). The clinical evaluation will be repeated every 6 months and will allow the recording of the date of occurrence of the study events. In addition, annually, patients will be subjected to cardiac rhythm monitoring by electronic devices with the aim of improving AF detection.
Detailed description
Design: Multicenter, prospective cohort study Setting and study population: Patients will be recruited from the usual consultations in six Primary Health Care Centers (PHCC) managed by the Catalan Health Institute (ICS), two in Tarragonés county and four in Terres de l'Ebre county, both situated in Tarragona (South Catalonia, Spain).
Study subjects: Patients between 65-85 years old at high risk of FA who are attended at study' PHCCs, consent to participate, and meet inclusion criteria.
Follow-up: Initially all included patients will undertake echocardiography, biomarkers, and cranial /brain Magnetic resonance imaging (MRI). Cardiac monitoring (for 14 days) with two different electronic devices will be performed once every year during the study period. Every six-month electrocardiogram and complete clinical assessment will be done to register risk factors and comorbidities, new cardiovascular events, anthropometric parameters (arterial pressure, heart rate…), and scores at different tests related to functional status (Barthel or Rankin), cognitive function (Global Deterioration Scale [GBS], Mini-Mental State Examination [MMSE]), or AF / stroke risk (CHADsVASc, HAS-BLED). Any changes in the electronic prescription made by the professional according to the patient's assessment will also be recorded.
Data recording: Most of the study data will be recorded from evaluations/tests performed on patients (from anamnesis -including scales-, physical examination, and laboratory tests) or reports provided by specialists (available at computerized clinical history [e-SAP]), in the case of echocardiography (cardiologist) or MRI (radiologist) searching especially atrial dysfunction and signs of silent strokes. Data registered in the electronic primary care health records (e-CAP) of participants will also be collected. Therapeutic (pharmacological) changes will be registered from the SIRE (Catalan acronym for Integrated Electronic Prescription System). Finally, cardiac monitoring data will be collected through the electronic devices' registers. An ad hoc data collection questionnaire will be created to register and store all study variables. The electronic questionnaire will be available at a specific application (where data will remain stored for five years) accessible from the corporate (ICS) Intranet; only study researchers, through personal passwords, may record and access data.
Definition of the outcome variable: Time until the diagnosis of atrial fibrillation (confirmed by electrocardiogram), stroke (new diagnosis in e-CAP or confirmed by neuroimaging) , and cognitive impairment/dementia [diagnosed through Score in Global Deterioration Scale (GDS)].
Sample calculation: To detect a difference of 0.1 units in the prevalence of atrial fibrillation observed, compared to the reference (0.07) accepting an alpha risk of 0.05 and a beta risk of 0.05 a sample of 148 individuals will be required. Estimated loss rate at 15 per cent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients between 65-85 years old at high risk of AF will be recruited from the usual consultations in six Primary Health Care Centers (PHCC) managed by the Catalan Health Institute (ICS), two in Tarragonés county and four in Terres de l'Ebre county , both situated in Tarragona (South Catalonia, Spain).
Key inclusion criteria (4 listed)
- Patients between 65-85 years old
- Patients in Q4 (highest risk) of Atrial Fibrillation (AF). [Clua-Espuny et al, 2020]
- CHADsVASc ≥ 2
- Being capable of using a Smart phone (or the care giver)
Key exclusion criteria (5 listed)
- Patients with previous diagnostic of AF, stroke, or dementia.
- Patients treated with anticoagulants.
- Vital prognosis less than one year.
- Severe cognitive or functional impairment (GDS ≥ 3, and/or Barthel score ≤60, or MRS Rankin ≥4, or severe mobility impairment)
- Pacemaker Carrier
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 |
|---|---|---|
| ElectrocardiogramAlso: echocardiography, MRI, Smart Bracelet/watch, FibricheckThe electrocardiogram will help to diagnose atrial fibrillation and the electronic devices (App Fibricheck and Smart bracelet/watch) will help to detect an arrhythmic rhythm. The echocardiography will be used for detecting criteria of atrial cardiomyopathy. MRI may help to detect silent strokes. | Device | – |
Primary outcome
Atrial Fibrillation
Time frame: Through study completion, an average of 2 years
New diagnoses of atrial fibrillation could be made during protocolized evaluations every six months (including electrocardiography) or at any time during the study period, provided that an electrocardiogram is performed on the participant, on suspicion of arrhythmia or for any other reason. Moreover, a search for new-onset atrial fibrillation will be undertaken for 14 days twice during the study period, through cardiac monitoring with smart bracelets (constant monitoring) and using the FibriCheck application (two times a day and in case of symptoms). All new AF diagnoses will require confirmation via 12-lead electrocardiogram
Stroke
Time frame: Through study completion, an average of 2 years
Silent strokes may be detected through cranial MRI at initial evaluation. During the study period new stroke diagnoses will require confirmation through a neuroimaging test or neurologist assessment.
Cognitive impairment/ Dementia
Time frame: Through study completion, an average of 2 years
Cognitive impairment will be assessed through changes in the Global Deterioration Scale (GDS) score; scores from four will be considered diagnoses of dementia. This diagnosis will also be considered if confirmed through the neurologist's evaluation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Derived from this study: PubMed 38373864Hernandez-Pinilla A, Clua-Espuny JL, Satue-Gracia EM, Palleja-Millan M, Martin-Lujan FM; PREFA-TE Study-Group. Protocol for a multicentre and prospective follow-up cohort study of early detection of atrial fibrillation, silent stroke and cognitive impairment in high-risk primary care patients: the PREFA-TE study. BMJ Open. 2024 Feb 19;14(2):e080736. doi: 10.1136/bmjopen-2023-080736.
- Individual participant dataSharing planned: Yes. not yet decided as future studies are being considered and may be considered
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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.
Josep Lluís Clua-Espuny, MD PhD principal investigator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Eva Maria Satue-Gracia, MD PhD study director
Institut Català de la Salut
Francisco M. Martín-Luján, MD PhD study director
University Rovira i Virgili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Atrial Fibrillation New Onset, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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 4 inclusion and 5 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 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Josep Lluís Clua Espuny, MD PhD (0034648743908, jclua@telefonica.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial Fibrillation (time frame: Through study completion, an average of 2 years). The study lists 3 primary outcomes in all. 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 NCT05772806, which also lists 1 linked publication.
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 16 Mar 2023.