Diagnostic Approach of Early Atrial Fibrillation, Silent Stroke and Cognitive Disorder in Patients With High-risk

NCT05772806 | Unknown DMC

• 1 other identifier: SLT/21/000027
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Atrial Fibrillation; Atrial Fibrillation New Onset; Dementia; Stroke

Keywords

Atrial Fibrillation; Dementia; Stroke

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  Through study completion, an average of 2 years

Interventions

Electrocardiogram DEVICE

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.

Also known as: echocardiography, MRI, Smart Bracelet/watch, Fibricheck

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

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).

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Institut Català de la Salut: collaborator

Study Sites (1)

Eva Maria Satue Gracia

Tarragona, 43004, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 38373864 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood plasma and serum

MeSH Terms

Conditions

Atrial Fibrillation; Dementia; Stroke

Interventions

Electrocardiography; Echocardiography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Cardiac Imaging Techniques; Diagnostic Imaging; Ultrasonography

Study Officials

• Josep Lluís Clua-Espuny, MD PhD

  Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

  PRINCIPAL INVESTIGATOR

• Eva Maria Satue-Gracia, MD PhD

  Institut Català de la Salut

  STUDY DIRECTOR

• Francisco M. Martín-Luján, MD PhD

  University Rovira i Virgili

  STUDY DIRECTOR

Central Study Contacts

Josep Lluís Clua Espuny, MD PhD

CONTACT

0034648743908; jclua@telefonica.net

Eva María Satue Gracia, MD PhD

CONTACT

0034977778515; esatue.tgn.ics@gencat.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 16, 2023
• Study Start: January 15, 2023
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2024
• Last Updated: March 16, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2 years
• Access Criteria: The data will be entered on the IDIAP J Gol institution platform

Locations

ES (1)