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

May 10, 2019 updated by: Pawel Sokal, Jan Biziel University Hospital No 2 in Bydgoszcz

The Prevalence of a Low Ankle-Brachial Index in Patients With Acute Cerebral Ischemic Event.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

200

Contacts and Locations

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

Study Contact

Study Locations

  • Poland
      • Bydgoszcz, Poland, 85-168
        • Recruiting
        • Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University
        • Contact:
        • Contact:
          • Magdalena Konieczna- Brazis, M.D.
          • Phone Number: +48 609 711 611
          • Email: mpbrazis@wp.pl

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

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ABI
Time Frame: 7 days
Prevalence of a low ankle-brachial index (ABI) in patients with acute cerebral ischemic event
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ABI/ICAS
Time Frame: 7 days
Correlation between ABI and internal carotid artery stenosis (ICAS) in the acute cerebral ischemic patients.
7 days

Collaborators and Investigators

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

Sponsor

Jan Biziel University Hospital No 2 in Bydgoszcz

Investigators

  • Principal Investigator: Paweł Sokal, Ph.D., Jan Biziel University Hospital Collegium Medicum Nicolaus Copernicus University

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 (Actual)

January 1, 2018

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

May 10, 2019

First Submitted That Met QC Criteria

May 10, 2019

First Posted (Actual)

May 13, 2019

Study Record Updates

Last Update Posted (Actual)

May 13, 2019

Last Update Submitted That Met QC Criteria

May 10, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JBUH-ABI-CIE-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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