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出境医 / 临床实验 / The Prevalence of a Low Ankle-Brachial Index in Acute Cerebral Ischemia.

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

Study Description
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.

Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
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.


Eligibility Criteria
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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.
Contacts and Locations

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
Layout table for investigator information
Principal Investigator: Paweł Sokal, Ph.D. Jan Biziel University Hospital Collegium Medicum Nicolaus Copernicus University
Tracking Information
First Submitted Date May 10, 2019
First Posted Date May 13, 2019
Last Update Posted Date May 13, 2019
Actual Study Start Date January 1, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 10, 2019) 		ABI [ Time Frame: 7 days ]
Prevalence of a low ankle-brachial index (ABI) in patients with acute cerebral ischemic event
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 10, 2019) 		ABI/ICAS [ Time Frame: 7 days ]
Correlation between ABI and internal carotid artery stenosis (ICAS) in the acute cerebral ischemic patients.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Prevalence of a Low Ankle-Brachial Index in Acute Cerebral Ischemia.
Official Title The Prevalence of a Low Ankle-Brachial Index in Patients With Acute Cerebral Ischemic Event.
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.
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Ischemic Stroke
Intervention
  • Device: Duplex scanning of carotid arteries
    Measurement of carotid arteries
  • Device: ABI measurement
    ankle brachial index (ABI) assessment
Study Groups/Cohorts
  • STROKE GROUP
    150 patients admitted to Stroke Unit with a diagnosis of acute ischemic stroke (IS) or transient ischemic attack (TIA)
    Interventions:
    • Device: Duplex scanning of carotid arteries
    • Device: ABI measurement
  • CONTROL GROUP
    50 individuals admitted to hospital without diagnosis of acute cerebrovascular disease; with diagnosis of dizziness, epilepsy, sclerosis multiplex.
    Interventions:
    • Device: Duplex scanning of carotid arteries
    • Device: ABI measurement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 10, 2019) 		200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Poland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03948399
Other Study ID Numbers JBUH-ABI-CIE-2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Pawel Sokal, Jan Biziel University Hospital No 2 in Bydgoszcz
Study Sponsor Jan Biziel University Hospital No 2 in Bydgoszcz
Collaborators Not Provided
Investigators
Principal Investigator: Paweł Sokal, Ph.D. Jan Biziel University Hospital Collegium Medicum Nicolaus Copernicus University
PRS Account Jan Biziel University Hospital No 2 in Bydgoszcz
Verification Date May 2019

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