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The Prevalence of a Low Ankle-Brachial Index in Acute Cerebral Ischemia.

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ClinicalTrials.gov Identifier: NCT03948399
Recruitment Status : Recruiting
First Posted : May 13, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Pawel Sokal, Jan Biziel University Hospital No 2 in Bydgoszcz

Brief Summary:

Aim of the study is assessment the prevalence of the low ankle-brachial index (ABI) defined less than or equal 0.9 in patients with acute cerebral ischemic event (stroke or transient ischemic attack) and determinate the correlation between ABI and internal carotid artery stenosis (ICAS) in the acute cerebral ischemic patients.

The low ABI is a strong marker of generalized atherosclerosis. LEAD is a strong independent predictor for stroke.


Condition or disease Intervention/treatment
Ischemic Stroke Device: Duplex scanning of carotid arteries Device: ABI measurement

Detailed Description:

Aim of the study is assessment the prevalence of the low ankle-brachial index (ABI) defined less than or equal 0.9 in patients with acute cerebral ischemic event (stroke or transient ischemic attack) and determinate the correlation between ABI and internal carotid artery stenosis (ICAS) in the acute cerebral ischemic patients.

The ABI is a non-invasive tool useful for the diagnosis of LEAD. The low ABI is a strong marker of generalized atherosclerosis. LEAD is a strong independent predictor for stroke. Significant ICAS is prevalent among patients having LEAD. Acute ischemic stroke due to significant ICAS has poor prognosis.

Patients with LEAD may be a suitable subgroup for screening for ICAS using duplex scanning.

Estimating the relationship between cerebral ischemic event and the ABI value could help better guide preventive and risk reduction strategies.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: The Prevalence of a Low Ankle-Brachial Index in Patients With Acute Cerebral Ischemic Event.
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Group/Cohort Intervention/treatment
STROKE GROUP
150 patients admitted to Stroke Unit with a diagnosis of acute ischemic stroke (IS) or transient ischemic attack (TIA)
Device: Duplex scanning of carotid arteries
Measurement of carotid arteries

Device: ABI measurement
ankle brachial index (ABI) assessment

CONTROL GROUP
50 individuals admitted to hospital without diagnosis of acute cerebrovascular disease; with diagnosis of dizziness, epilepsy, sclerosis multiplex.
Device: Duplex scanning of carotid arteries
Measurement of carotid arteries

Device: ABI measurement
ankle brachial index (ABI) assessment




Primary Outcome Measures :
  1. ABI [ Time Frame: 7 days ]
    Prevalence of a low ankle-brachial index (ABI) in patients with acute cerebral ischemic event


Secondary Outcome Measures :
  1. ABI/ICAS [ Time Frame: 7 days ]
    Correlation between ABI and internal carotid artery stenosis (ICAS) in the acute cerebral ischemic patients.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients attending to hospital settings diagnosed with acute ischemic event (stroke or TIA) and control group individuals undergo computed tomography (CT) or magnetic resonance imaging (MRI) of the brain, lipid profile, had stroke risk factors assessed.
Criteria

Inclusion Criteria:

  • Acute ischemic stroke or transient ischemic attack of anterior circulation
  • Consent of patient

Exclusion Criteria:

  • primary intracranial hemorrhage,
  • venous sinus thrombosis,
  • unconsciousness,
  • intubation,
  • inability to provide and write a consent application form.

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): NCT03948399


Contacts
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Contact: Paweł Sokal, Ph.D. 600954415 ext 48 pawel.sokal@cm.umk.pl

Locations
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Poland
Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University Recruiting
Bydgoszcz, Poland, 85-168
Contact: Paweł Sokal, Ph.D.    +48600954415    pawel.sokal@cm.umk.pl   
Contact: Magdalena Konieczna- Brazis, M.D.    +48 609 711 611    mpbrazis@wp.pl   
Sponsors and Collaborators
Jan Biziel University Hospital No 2 in Bydgoszcz
Investigators
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Principal Investigator: Paweł Sokal, Ph.D. Jan Biziel University Hospital Collegium Medicum Nicolaus Copernicus University
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Responsible Party: Pawel Sokal, Paweł Sokal, Jan Biziel University Hospital No 2 in Bydgoszcz
ClinicalTrials.gov Identifier: NCT03948399    
Other Study ID Numbers: JBUH-ABI-CIE-2018
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pawel Sokal, Jan Biziel University Hospital No 2 in Bydgoszcz:
Ischemic Stroke
TIA
ABI
LEAD
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes