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| ID | Type | Description | Link |
|---|---|---|---|
| PI11/00296 | Other Grant/Funding Number | FONDO DE INVESTIGACIONES SANITARIAS |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral anticoagulants | Patients who will receive oral anticoagulants indefinitely for the secondary prevention of cardioembolic stroke |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral anticoagulants | Drug | Comparison of patients receiving oral anticoagulants with or without microbleeds in magnetic resonance imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intracranial Hemorrhage | Telephone interview every 3 months, starting 3 months after ischemic stroke (3, 6, 9, 12, 15, 18, 21 and 24 months) | every 3 months after stroke, until 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ischemic stroke | within 24 months after inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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Patients admitted to tertiaty hospital for cardioembolic ischemic stroke
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| Name | Affiliation | Role |
|---|---|---|
| Joan Martí-Fàbregas, MD,PhD | Biomedical Research Institute Sant Pau (IIB Sant Pau) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arcispedale Santa Maria Nuova IRCCS | Reggio Emilia | Italy | ||||
| Hospital Germans Trias i Pujol |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31004066 | Derived | Marti-Fabregas J, Medrano-Martorell S, Merino E, Prats-Sanchez L, Marin R, Delgado-Mederos R, Martinez-Domeno A, Camps-Renom P, Jimenez-Xarrie E, Zedde M, Gomez-Choco M, Lara L, Boix A, Calleja A, De Arce-Borda AM, Bravo Y, Fuentes B, Hernandez-Perez M, Canovas D, Llull L, Zandio B, Freijo M, Casado-Naranjo I, Sanahuja J, Cocho D, Krupinski J, Rodriguez-Campello A, Palomeras E, De Felipe A, Serrano M, Zapata-Arriaza E, Zaragoza-Brunet J, Diaz-Maroto I, Fernandez-Dominguez J, Lago A, Maestre J, Rodriguez-Yanez M, Gich I; HERO study investigators. MRI predicts intracranial hemorrhage in patients who receive long-term oral anticoagulation. Neurology. 2019 May 21;92(21):e2432-e2443. doi: 10.1212/WNL.0000000000007532. Epub 2019 Apr 19. |
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| Badalona |
| Barcelona |
| Spain |
| Fundació Hospital Asil Granollers | Granollers | Barcelona | Spain |
| Hospital de Mataró | Mataró | Barcelona | Spain |
| Hospital Parc Taulí | Sabadell | Barcelona | Spain |
| Hospital Moisés Broggi | Sant Joan Despí | Barcelona | Spain |
| Mutua de Terrassa | Terrassa | Barcelona | Spain |
| Hospital de la Cinta | Tortosa | Tarragona | Spain |
| Hospital de Albacete | Albacete | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
| Hospital Clínic | Barcelona | Spain |
| Hospital del Mar | Barcelona | Spain |
| Hospital de Basurto | Bilbao | Spain |
| Hospital CA de Burgos | Burgos | Spain |
| Hospital San Pedro de Alcántara | Cáceres | Spain |
| Hospital de Donostia | Donostia / San Sebastian | Spain |
| Hospital Virgen de las Nieves | Granada | Spain |
| Hospital de León | León | Spain |
| Hospital Arnau de Vilanova | Lleida | Spain |
| Hospital La Rioja | Logroño | Spain |
| Hospital Gregorio Marañón | Madrid | Spain |
| Hospital Ramón y Cajal | Madrid | Spain |
| Hospital Universitario La Paz | Madrid | Spain |
| Centro Médico Asturias | Oviedo | Spain |
| Hospital Son Espases | Palma de Mallorca | Spain |
| Hospital de Navarra | Pamplona | Spain |
| CHU Santiago de Compostela | Santiago de Compostela | Spain |
| Hospital Virgen del Rocío | Seville | Spain |
| Hospital La Fe | Valencia | Spain |
| Hospital CU de Valladolid | Valladolid | Spain |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D002543 | Cerebral Hemorrhage |
| D006408 | Hematoma, Subdural |
| D049292 | Leukoaraiosis |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020300 | Intracranial Hemorrhages |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D006406 | Hematoma |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000925 | Anticoagulants |
| D014859 | Warfarin |
| C030123 | coumarin |
| D000069604 | Dabigatran |
| D000069552 | Rivaroxaban |
| C522181 | apixaban |
| ID | Term |
|---|---|
| D006401 | Hematologic Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
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