Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Atrial Fibrillation as a Cause of Stroke and Intracranial Hemorrhage Study (The FibStroke Study) (FibStroke)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02146040
Recruitment Status : Unknown
Verified May 2014 by Juhani Airaksinen, University of Turku.
Recruitment status was:  Active, not recruiting
First Posted : May 23, 2014
Last Update Posted : May 23, 2014
Sponsor:
Information provided by (Responsible Party):
Juhani Airaksinen, University of Turku

Brief Summary:

The aim of this study is to evaluate the role of atrial fibrillation (AF) and its treatment in relation to thromboembolic events (stroke, and transient ischemic attacks) and intracranial hemorrhage.

Primary Outcome Measures:

- Incidence and timing of intracranial complications (stroke,TIA, bleedings) in relation to diagnosis and anticoagulation treatment of AF during the study period; comparison of complications between those with and without anticoagulation treatment according to CHADSVASc score.

Secondary Outcome Measures:

  • The effect of anticoagulation pauses and INR level on stroke and bleeding risk; strokes within 30 days after anticoagulation pause and the prevalence of stroke and intracranila bleeding in relation to INR level < 2, 2-3 and >3.
  • Trauma as a risk factor for intracranial bleeding: percentage and risk factors for intracranial bleeding with or without trauma. Type of preceding trauma and type of intracranial bleeding.
  • The time relation between diagnosis of AF and type of intracranial complications: Kaplan Meier analysis of thrombotic (Stroke/TIA) and intracranial bleeding complications after 1st diagnosis of AF in patients with and without anticoagulation
  • The risk of stroke and intracranial bleeding in relation to CHADSVASc score, HAS-BLED score and anticoagulation/antithrombotic treatment
  • Prognosis of stroke and intracranial bleeding: 30-day mortality after stroke and intracerebral bleeding in patients with and without anticoagulation
  • Factors related to underuse of anticoagulation treatment. Data on reasons for not starting or stopping aticoagulation in those with indication of oral anticoagulation
  • Operations and procedure as risk factor for stroke: Frequency and type of operations performed < 30 days before stroke. Data on length of perioperative pause in anticoagulation and use of bridging therapy and timiing of stroke are collected.
  • Cardioversions as a risk factor for stroke: Frequency of stroke and TIA < 30 days after cardioversion in relation to use of anticoagulation and CHADSVASc score
  • The risk of stroke and intracranial bleeding in relation to type of AF (permanent, persistent, paroxysmal) and concomitant carotid disease

Estimated Enrollment: 6000 patients.


Condition or disease
Stroke Transient Ischemic Attacks Intracranial Hemorrhage Atrial Fibrillation

Detailed Description:

Approximately 20% of stroke is caused by atrial fibrillation (AF) and 1% of patients with AF suffer from intracranial hemorrhage. Thus, the net benefit of AF management is the key factor in choosing the successful treatment (pharmacological and interventional).

In this retrospective Finnish multicenter study the investigators collect data on patients with intracranial thromboembolic events or intracranial hemorrhage and AF during the study period. All such patients ≥18 years of age are identified and relevant clinical details are retrospectively gathered from the hospital records of the participating hospitals into an internet-based CRF. The total study period is from 2003 to 2012.

All case records are reviewed using standardized data collection protocol to get information on baseline characteristics and medication of the patients, management of the patients before and during the index complication and during a 30-day follow-up after each complication.

Diagnosis of atrial fibrillation is based 12-lead electrocardiography according to the standard criteria.

Stroke is documented clinically and confirmed by computerized tomography or magnetic resonance imaging to be caused by cerebral infarction. Diagnosis of transient ischemic attacks are based on clinical diagnosis by neurologist when stroke is not confirmed by imaging. After completion of manual registration of data, a computer-based cross-checking of strokes is performed from discharge register data of the included patients to ensure the complete coverage of all events. Diagnosis of inctracranial bleedings are based on patient record and classified as subdural, subarachnoidal and intracerebral and possible preceding trauma is registered. Outcome measures are classified by study neurologist when necessary.

Antigoagulation treatment, INR levels during the index complication, possible pauses in treatment and their casues are registered togethr with information on antiplatelet treatments.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Incidence and Clinical Predictors of Stroke and Intracranial Hemorrhage in Patients With Atrial Fibrillation. A Retrospective Multicenter Study
Study Start Date : October 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Incidence of intracranial complications in relation to diagnosis and anticoagulation treatment of AF during the study period. [ Time Frame: up to 9 years ]

Secondary Outcome Measures :
  1. The number and the timing of TIAs and strokes in relation to anticoagulation pauses. [ Time Frame: up to 9 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients aged 18 or over, hospitalized or having emergency unit visit during the study period because of thromboembolic event (stroke, TIA) or intracranial hemorrhage and having the diagnosis of atrial fibrillation.
Criteria

Inclusion Criteria:

  • All patients aged 18 or over, hospitalized or having emergency unit visit during the study period because of thromboembolic event (stroke, TIA) or intracranial hemorrhage and having the diagnosis of atrial fibrillation.

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02146040


Locations
Layout table for location information
Finland
Keski-Suomi Central Hospital
Jyväskylä, Finland
Kuopio University Hospital
Kuopio, Finland
Satakunta Central Hospital
Pori, Finland
Turku University Hospital
Turku, Finland, 20521
Sponsors and Collaborators
University of Turku
Investigators
Layout table for investigator information
Principal Investigator: Juhani Airaksinen, Professor Turku University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Juhani Airaksinen, Professor, University of Turku
ClinicalTrials.gov Identifier: NCT02146040     History of Changes
Other Study ID Numbers: T137/2012
First Posted: May 23, 2014    Key Record Dates
Last Update Posted: May 23, 2014
Last Verified: May 2014
Keywords provided by Juhani Airaksinen, University of Turku:
anticoagulation
atrial fibrillation
cardioversion
complications
hemorrhage
medications
thromboembolism
TIA
stroke
treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Ischemic Attack, Transient
Intracranial Hemorrhages
Atrial Fibrillation
Hemorrhage
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Brain Ischemia