Atrial Fibrillation (AF), Ischemic Stroke
Conditions
Brief summary
Acute ischaemic strokes occur despite the use of direct oral anticoagulants (DOACs). Evidence-based scale is necessary to assess ischemic stroke risk in atrial fibrillation (AF) patients.
Interventions
OTHERDOAC Level
Testing for plasma DOAC level concentration to determine 'on-therapy' status
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Patient over 18 years of age * History of AD * Currently on DOACs. * Capacity to understand the study procedures and provide informed consent.
Exclusion criteria
* Patient with valvular AF (mitral stenosis) or mechanical valve prostheses. * Unable to complete a follow-up period of at least 3 months from enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stroke Risk Scale | From January 2023 to December 2027 | To design and validate a stroke risk scale specific to AF patients undergoing DOAC therapy (target patients), through retrospective analysis of a population sample, based on demographic, clinical, socioeconomic and gender factors; as well as other newly identified factors. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma DOACs level | From January 2023 to December 2027 | To determine plasma levels of DOACs in two prospective cohorts of target patients who have or have not had a stroke to assess stroke risk scale |
| Burden of atrial disease | From January 2023 to December 2027 | Analyze the burden of atrial disease (AF burden on Holter and atrial size) in each of the prospective cohorts. |
| Large Intracranial Vessel Occlusion (LVO) | Until the end of the study | To quantify the proportion of thrombotic events evidenced as large intracranial vessel occlusion or intracardiac thrombus in the prospective cohort of AF patients treated with DOACs who present with a stroke. |
| Adherence to DOAC treatment | From January 2023 to December 2027 | To evaluate the impact of a clinical intervention of education on disease and treatment on adherence to DOAC treatment, as determined by a medication adherence scale and plasma levels of DOAC at 3 months from baseline determination in each of the prospective cohort. |
Countries
Spain
Outcome results
None listed