Intracerebral Hemorrhage Due to Oral Anticoagulants: Prediction of the Risk by Magnetic Resonance (HERO)

August 1, 2018 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Intracerebral Hemorrhage Due to Oral Anticoagulants in the Secondary Prevention of Ischemic Stroke: Prediction of the Risk by the Detection of Leukoaraiosis and Microbleeding With Magnetic Resonance

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Reggio Emilia, Italy
        • Arcispedale Santa Maria Nuova IRCCS
  • Spain
      • Albacete, Spain
        • Hospital de Albacete
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital Clínic
      • Bilbao, Spain
        • Hospital de Basurto
      • Burgos, Spain
        • Hospital CA de Burgos
      • Cáceres, Spain
        • Hospital San Pedro de Alcantara
      • Donostia, Spain
        • Hospital de Donostia
      • Granada, Spain
        • Hospital Virgen de las Nieves
      • León, Spain
        • Hospital de Leon
      • Lleida, Spain
        • Hospital Arnau de Vilanova
      • Logroño, Spain
        • Hospital La Rioja
      • Madrid, Spain
        • Hospital Ramón y Cajal
      • Madrid, Spain
        • Hospital Gregorio Marañón
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Oviedo, Spain
        • Centro Médico Asturias
      • Palma de Mallorca, Spain
        • Hospital Son Espases
      • Pamplona, Spain
        • Hospital de Navarra
      • Santiago de Compostela, Spain
        • CHU Santiago de Compostela
      • Sevilla, Spain
        • Hospital Virgen del Rocio
      • Valencia, Spain
        • Hospital La Fe
      • Valladolid, Spain
        • Hospital CU de Valladolid
    • Barcelona
      • Badalona, Barcelona, Spain
        • Hospital Germans Trias i Pujol
      • Granollers, Barcelona, Spain
        • Fundació Hospital Asil Granollers
      • Mataró, Barcelona, Spain
        • Hospital de Mataro
      • Sabadell, Barcelona, Spain
        • Hospital Parc Tauli
      • Sant Joan Despí, Barcelona, Spain
        • Hospital Moisés Broggi
      • Terrassa, Barcelona, Spain
        • Mutua de Terrassa
    • Tarragona
      • Tortosa, Tarragona, Spain
        • Hospital de la Cinta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients admitted to tertiaty hospital for cardioembolic ischemic stroke

Description

Inclusion Criteria:

  1. Age > 65 y
  2. TIA or ischemic stroke
  3. The patient will receive indefinitely treatment with oral anticoagulants for the secondary prevention of cardioembolic stroke
  4. No previous treatment with oral anticoagulants
  5. Signed consent before performing a Magnetic Resonance
  6. Long-term follow-up will be possible

Exclusion Criteria:

  1. The patient will receive oral anticoagulation as a primary prevention treatment
  2. The etiology that motivates the onset of oral anticoagulants is not cardioembolism
  3. Absolute contraindication to receive oral anticoagulants
  4. Arterial hypertension that is not controlled, hypertensive crisis
  5. Dementia
  6. Live-expectancy less than 1 year
  7. Any social or psychological reason that prevents follow-up
  8. Contraindication to perform a Magnetic Resonance examination
  9. Patients who received oral antiacoagulants prior to the current stroke
  10. The Magnetic Resonance imaging was performed more than 1 month after the onset of treatment with oral anticoagulants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Oral anticoagulants
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
Other Names:
  • warfarin
  • apixaban
  • rivaroxaban
  • dabigatran
  • coumarin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intracranial Hemorrhage
Time Frame: every 3 months after stroke, until 24 months
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 Outcome Measures

Outcome Measure
Time Frame
Ischemic stroke
Time Frame: within 24 months after inclusion
within 24 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Investigators

  • Principal Investigator: Joan Martí-Fàbregas, MD,PhD, Biomedical Research Institute Sant Pau (IIB Sant Pau)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

September 10, 2014

First Submitted That Met QC Criteria

September 10, 2014

First Posted (Estimate)

September 12, 2014

Study Record Updates

Last Update Posted (Actual)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-ACO-2010-10
  • PI11/00296 (Other Grant/Funding Number: FONDO DE INVESTIGACIONES SANITARIAS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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