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

NCT05772806 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 148

Last updated 2023-03-16

No results posted yet for this study

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

Interventions

DEVICE

Electrocardiogram

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.

Sponsors & Collaborators

  • Institut Català de la Salut

    collaborator OTHER

  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    lead OTHER

Principal Investigators

  • Josep Lluís Clua-Espuny, MD PhD · IDIAP JORDI GOL

  • Eva Maria Satue-Gracia, MD PhD · Institut Català de la Salut

  • Francisco M. Martín-Luján, MD PhD · University Rovira i Virgili

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-15
Primary Completion
2023-09-30
Completion
2024-12-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05772806 on ClinicalTrials.gov