Intracerebral Hemorrhage Due to Oral Anticoagulants: Prediction of the Risk by Magnetic Resonance
HERO
2 other identifiers
observational
1,000
2 countries
30
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2012
Longer than P75 for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 10, 2014
CompletedFirst Posted
Study publicly available on registry
September 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedAugust 3, 2018
August 1, 2018
5.4 years
September 10, 2014
August 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Ischemic stroke
within 24 months after inclusion
Study Arms (1)
Oral anticoagulants
Patients who will receive oral anticoagulants indefinitely for the secondary prevention of cardioembolic stroke
Interventions
Comparison of patients receiving oral anticoagulants with or without microbleeds in magnetic resonance imaging
Eligibility Criteria
Patients admitted to tertiaty hospital for cardioembolic ischemic stroke
You may qualify if:
- Age \> 65 y
- TIA or ischemic stroke
- The patient will receive indefinitely treatment with oral anticoagulants for the secondary prevention of cardioembolic stroke
- No previous treatment with oral anticoagulants
- Signed consent before performing a Magnetic Resonance
- Long-term follow-up will be possible
You may not qualify if:
- The patient will receive oral anticoagulation as a primary prevention treatment
- The etiology that motivates the onset of oral anticoagulants is not cardioembolism
- Absolute contraindication to receive oral anticoagulants
- Arterial hypertension that is not controlled, hypertensive crisis
- Dementia
- Live-expectancy less than 1 year
- Any social or psychological reason that prevents follow-up
- Contraindication to perform a Magnetic Resonance examination
- Patients who received oral antiacoagulants prior to the current stroke
- The Magnetic Resonance imaging was performed more than 1 month after the onset of treatment with oral anticoagulants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Arcispedale Santa Maria Nuova IRCCS
Reggio Emilia, Italy
Hospital Germans Trias i Pujol
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
Related Publications (1)
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.
PMID: 31004066DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joan Martí-Fàbregas, MD,PhD
Biomedical Research Institute Sant Pau (IIB Sant Pau)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2014
First Posted
September 12, 2014
Study Start
April 1, 2012
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
August 3, 2018
Record last verified: 2018-08