Clinical trial NCT04162587: Extracranial Carotid & Intracranial Arterial Stenosis in Ischemic Stroke
Official title: Association Between Extracranial Carotid & Intracranial Arterial Stenosis in Ischemic Stroke Patients: Predictors & Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Carotid Stenosis
Keywords: Ischemic Stroke
carotid stenosis
Lead sponsor: Mansoura University Hospital
Sponsor class: OTHER
First posted: 2019-11-14
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: National Institutes of Health Stroke Scale
timeFrame: 24 hours
Secondary outcomes:
measure: The modified Rankin Scale
timeFrame: 24 hours
measure: Beck's Depression Inventory
timeFrame: 24hours
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
Study officials:
affiliation: Assistant Prof of Neurology
name: Esmael M Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
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