Using cardiac monitors to detect silent atrial fibrillation in stroke patients
Subtle Ultrasound Atrial Anomalies Predicts the Early Diagnosis of Silent Atrial Fibrillation Detected by Implantable Cardiac Monitor in Patients With Cryptogenic Stroke. A Randomized Trial
NA · Parc de Salut Mar · NCT06542770
This study is testing if implantable heart monitors can help find hidden heart rhythm problems in stroke patients who don’t know they have them.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 50 Years to 89 Years |
| Sex | All |
| Sponsor | Parc de Salut Mar (other) |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06542770 on ClinicalTrials.gov |
What this trial studies
This investigation aims to evaluate the effectiveness of implantable cardiac monitors (ICM) for the early detection of silent paroxysmal atrial fibrillation (PAF) in patients who have experienced a cryptogenic stroke. The study will involve a randomized prospective unicentric approach, focusing on clinical and ultrasound predictors of PAF occurrence, particularly atrial contraction strain (ACS). By identifying patients at higher risk for silent PAF, the study seeks to improve monitoring strategies and treatment outcomes. The research is motivated by the need for clearer guidelines regarding the use of ICM in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 50 to 89 who have experienced an acute ischemic stroke or transient ischemic attack of undetermined origin.
Not a fit: Patients with a history of hemorrhagic stroke, prior atrial fibrillation, or severe cardiac abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection and management of silent atrial fibrillation in stroke patients, potentially reducing the risk of future strokes.
How similar studies have performed: Previous studies have shown mixed results regarding the use of implantable cardiac monitors in similar contexts, but early implantation has demonstrated clear benefits in diagnostic yield.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Acute ischemic stroke or transient ischemic attack (TIA) from January 2022 to July 2023 * Age between 50 and 89 years; * Undetermined origin at hospital admission according to the SSS-TOAST criteria (2): 1. Absence of major structural heart disease by cardiac ultrasound (normal global and segmental left ventricle contraction, absence of valvular/rheumatic disease, absence of intracardiac shunts) 2. Absence of AF during 48h ECG-monitoring 3. Absence of major anomalies in the supra-aortic trunks ultrasound. Exclusion Criteria: 1. Patients with a history of hemorrhagic stroke; 2. Presence with prior atrial fibrillation or atrial flutter; 3. Permanent contraindication or indication for OAC for other reasons; 4. Recent (\<1 month) major surgery or cardiac events; 5. Presence of severe cardiac abnormalities; 6. Patients with life expectancy \<1 year or severe stroke (modified Rankin Scale \> 4).
Where this trial is running
Barcelona
- Hospital del Mar — Barcelona, Spain (RECRUITING)
Study contacts
- Principal investigator: Ermengol Valles Gras, PhD — Hospital del Mar
- Study coordinator: Ermengol Valles Gras, PhD
- Email: evalles@psmar.cat
- Phone: 932 48 3118
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Paroxysmal Atrial Fibrillation, Cardiac Rhythm Disorder, Left Atrial Dilatation, Cryptogenic Stroke, Atrial strain. Implantable cardiac monitor