An observational study in Ischemic Stroke, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Completed at 30 sites in 2 countries. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2018-08-03.
Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Observational
The purpose of this study is to determine whether Magnetic Resonance Imaging may predict the risk of Intracerebral Hemorrhage for patients with ischemic stroke who receive indefinite oral anticoagulation
OBJECTIVES. To evaluate whether Magnetic Resonance (MR) helps in predicting the risk of Intracranial Hemorrhage (ICH-OA) in patients with ischemic stroke who will receive Oral Anticoagulants (OA) for the secondary prevention of stroke. By allowing the detection and quantification of leukoaraiosis and microbleeding, MR aids in the assessment of hypertensive and/or amyloid angiopathy, two findings that may increase the risk of ICH-OA. The study of these and other known variables associated with the risk of ICH-OA will improve the selection of patients to be treated with OA. METHODOLOGY. A prospective, observational, multicentric study of 1000 patients with stroke, older than 65 y, candidates to receive OA indefinitely. The primary end-point is ICH-OA. A MR will be performed before starting the treatment, in which we will evaluate the presence and degree of leukoaraiosis (Fazekas's scale) and microbleeding (BOMBS scale). A visit will be scheduled at the first month after inclusion, and thereafter the patient will be followed-up during 2 years with phone interviews, to evaluate the appearance of the primary end-point. We will register data about demographics, vascular risk factors, anticoagulation, MR, echocardiography and co-morbidity. With those variables associated with ICH-OA in the univariate analyses, a regression analysis will be performed, in which ICH-OA will be the dependent variable. Finally, each independent predictive variable will receive a score to elaborate a predictive model of ICH-OA.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 1,000 is above the median of 160 across 1,692 observational studies indexed under Stroke.
Browse Stroke studies →Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients admitted to tertiaty hospital for cardioembolic ischemic stroke
Exclusion Criteria:
Patients who will receive oral anticoagulants indefinitely for the secondary prevention of cardioembolic stroke
Drug: oral anticoagulants
Comparison of patients receiving oral anticoagulants with or without microbleeds in magnetic resonance imaging
Also known as: warfarin, coumarin, dabigatran, rivaroxaban, apixaban
Intracranial Hemorrhage
Telephone interview every 3 months, starting 3 months after ischemic stroke (3, 6, 9, 12, 15, 18, 21 and 24 months)
Time frame: every 3 months after stroke, until 24 months
Ischemic stroke
Time frame: within 24 months after inclusion
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau