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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03948399
• Other study ID #: JBUH-ABI-CIE-2018
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2019
• Source: Jan Biziel University Hospital No 2 in Bydgoszcz
• Contact: Pawel Sokal, Ph.D.
• Phone: 600954415
• Email: pawel.sokal[@]cm.umk.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke

Intervention

Device:
• Duplex scanning of carotid arteries
Measurement of carotid arteries
• ABI measurement
ankle brachial index (ABI) assessment

Locations

Country	Name	City	State
Poland	Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University	Bydgoszcz

Sponsors (1)

Lead Sponsor	Collaborator
Jan Biziel University Hospital No 2 in Bydgoszcz

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ABI	Prevalence of a low ankle-brachial index (ABI) in patients with acute cerebral ischemic event	7 days
Secondary	ABI/ICAS	Correlation between ABI and internal carotid artery stenosis (ICAS) in the acute cerebral ischemic patients.	7 days