Extracranial Carotid & Intracranial Arterial Stenosis in Ischemic Stroke

November 16, 2019 updated by: Ahmed Esmael, Mansoura University Hospital

Association Between Extracranial Carotid & Intracranial Arterial Stenosis in Ischemic Stroke Patients: Predictors & Outcome

The aim of the work is to; elucidate how the presence of carotid stenosis influence the pattern of stroke and also how it interact with other risk factors for stroke. Also identify predictors of intracranial stenosis and outcome in patients with carotid stenosis with or without intracranial stenosis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients:

Ischemic stroke patients admitted to Neurology department in Mansoura University hospital (MUH) will be studied

The patients will be grouped as follow:

  1. Patients with significant carotid stenosis without intracranial stenosis.
  2. Patients with carotid and intracranial stenosis.
  3. Patients with lone intracranial stenosis.
  4. patients with no significant carotid or intracranial stenosis.

Methods:

Studied patients will undergo the following:

  • Clinical assessment with NIH scale with is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit, Modified Rankin Scale, Arabic version of Montereal Coginitive Assessment and Arabic version of Beck's Depression Inventory at presentation and after 6 months.
  • carotid duplex+/- MRA neck and brain MRA+/-CT angio on carotid and brain (at 0day) and 6m after.
  • MRI brain with diffusion to detect asymptomatic stroke at 0 day and 6 months later.
  • DSA (digital subtraction angiography) in some cases to confirm diagnosis.
  • Laboratory investigations: complete blood count, liver function and renal function tests, random blood sugar, lipid profile.

All patients will be treated with acetyle-salicylic acid(150/day) +/-clopidogrel (75mg /day) +/- statins, plus modification of risk factors.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

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

Study Locations

  • Egypt
      • Mansoura, Egypt
        • Recruiting
        • Mansoura University Hospital

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

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

141 patients of acute ischemic stroke presented by carotid TIA (transient ischemic attack) or asymptomatic patients with carotid stenosis or anterior circulation stenosis discovered accidentally during investigations for further risk factors.

Description

Inclusion Criteria:

  • Carotid TIA (transient ischemic attack) it should, however, be focal and usually motor-sensory to implicate the carotid artery system or ischemic stroke involving carotid territory.
  • Asymptomatic patients with carotid stenosis or anterior circulation stenosis discovered accidentally during investigations for further risk factors.

Exclusion Criteria:

  • Major functional impairment (Modified Rankin Scale >/= 3)
  • Significant cognitive impairment.
  • Contraindication to acetylsalicylic or dual antiplatelet.
  • Renal dysfunction precluding safe contrast medium administration.
  • pregnancy or refusal.
  • Intracranial aneurysm or AVM.
  • Intra cerebral hemorrhage or hemorrhagic infarction.

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
1)Patients with significant carotid stenosis only
Patients with significant carotid stenosis without intracranial stenosis.
Other: Carotid duplex+/- MRA neck
Carotid duplex and or MRA neck
Other: brain MRA+/-CT angio on carotid and brain
brain MRA and or CT angiography on carotid and brain
Other: MRI brain
MRI brain with diffusion to detect asymptomatic stroke
Other: DSA (digital subtraction angiography)
DSA (digital subtraction angiography) in some cases to confirm diagnosis.
2) Patients with carotid and intracranial stenosis.
Patients with carotid and intracranial stenosis.
Other: Carotid duplex+/- MRA neck
Carotid duplex and or MRA neck
Other: brain MRA+/-CT angio on carotid and brain
brain MRA and or CT angiography on carotid and brain
Other: MRI brain
MRI brain with diffusion to detect asymptomatic stroke
Other: DSA (digital subtraction angiography)
DSA (digital subtraction angiography) in some cases to confirm diagnosis.
3) Patients with lone intracranial stenosis.
Patients with lone intracranial stenosis.
Other: Carotid duplex+/- MRA neck
Carotid duplex and or MRA neck
Other: brain MRA+/-CT angio on carotid and brain
brain MRA and or CT angiography on carotid and brain
Other: MRI brain
MRI brain with diffusion to detect asymptomatic stroke
Other: DSA (digital subtraction angiography)
DSA (digital subtraction angiography) in some cases to confirm diagnosis.
4) Patients with no significant stenosis
Patients with no significant carotid or intracranial stenosis.
Other: Carotid duplex+/- MRA neck
Carotid duplex and or MRA neck
Other: brain MRA+/-CT angio on carotid and brain
brain MRA and or CT angiography on carotid and brain
Other: MRI brain
MRI brain with diffusion to detect asymptomatic stroke

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
National Institutes of Health Stroke Scale
Time Frame: 24 hours
The National Institutes of Health Stroke Scale is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0. The higher score indicate poor outcome.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The modified Rankin Scale
Time Frame: 24 hours
The modified Rankin Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It has become the most widely used clinical outcome measure for stroke clinical trials. The higher score indicate poor outcome.
24 hours
Beck's Depression Inventory
Time Frame: 24hours
The Beck Depression Inventory, created by Aaron T. Beck, is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression.
24hours

Collaborators and Investigators

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

Sponsor

Mansoura University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 1, 2019

Primary Completion (ANTICIPATED)

April 1, 2020

Study Completion (ANTICIPATED)

August 1, 2020

Study Registration Dates

First Submitted

November 11, 2019

First Submitted That Met QC Criteria

November 11, 2019

First Posted (ACTUAL)

November 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2019

Last Update Submitted That Met QC Criteria

November 16, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mansoura University Hospital 4

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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