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

• Conditions: Ischemic Stroke
• Interventions: Device: Duplex scanning of carotid arteries; Device: ABI measurement

• Registration Number: NCT03948399
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-01-01
• Status Verified: 2019-05
• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-10
• Last Update Submitted: 2019-05-10
• Study First Posted: 2019-05-13
• Last Update Posted: 2019-05-13
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
STROKE GROUP	Duplex scanning of carotid arteries	150 patients admitted to Stroke Unit with a diagnosis of acute ischemic stroke (IS) or transient ischemic attack (TIA)
CONTROL GROUP	Duplex scanning of carotid arteries	50 individuals admitted to hospital without diagnosis of acute cerebrovascular disease; with diagnosis of dizziness, epilepsy, sclerosis multiplex.
STROKE GROUP	ABI measurement	150 patients admitted to Stroke Unit with a diagnosis of acute ischemic stroke (IS) or transient ischemic attack (TIA)
CONTROL GROUP	ABI measurement	50 individuals admitted to hospital without diagnosis of acute cerebrovascular disease; with diagnosis of dizziness, epilepsy, sclerosis multiplex.

Primary Outcome Measures

Name	Time	Method
ABI	7 days	Prevalence of a low ankle-brachial index (ABI) in patients with acute cerebral ischemic event

Secondary Outcome Measures

Name	Time	Method
ABI/ICAS	7 days	Correlation between ABI and internal carotid artery stenosis (ICAS) in the acute cerebral ischemic patients.

Trial Locations

Locations (1)

Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University; 🇵🇱 Bydgoszcz, Poland