Extracranial Carotid & Intracranial Arterial Stenosis in Ischemic Stroke

• Conditions: Carotid Stenosis; Ischemic Stroke
• Interventions: Other: Carotid duplex+/- MRA neck; Other: brain MRA+/-CT angio on carotid and brain; Other: MRI brain; Other: DSA (digital subtraction angiography)

• Registration Number: NCT04162587
• Lead Sponsor: Mansoura University Hospital

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.

Study Timeline

• Study Start: 2019-05-01
• Status Verified: 2019-11
• Study First Submitted: 2019-11-11
• Study First Submitted QC: 2019-11-11
• Study First Posted: 2019-11-14
• Last Update Submitted: 2019-11-16
• Last Update Posted: 2019-11-19
• Primary Completion: 2020-04-01
• Study Completion: 2020-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
4) Patients with no significant stenosis	MRI brain	Patients with no significant carotid or intracranial stenosis.
2) Patients with carotid and intracranial stenosis.	brain MRA+/-CT angio on carotid and brain	Patients with carotid and intracranial stenosis.
2) Patients with carotid and intracranial stenosis.	MRI brain	Patients with carotid and intracranial stenosis.
3) Patients with lone intracranial stenosis.	Carotid duplex+/- MRA neck	Patients with lone intracranial stenosis.
1)Patients with significant carotid stenosis only	brain MRA+/-CT angio on carotid and brain	Patients with significant carotid stenosis without intracranial stenosis.
1)Patients with significant carotid stenosis only	Carotid duplex+/- MRA neck	Patients with significant carotid stenosis without intracranial stenosis.
2) Patients with carotid and intracranial stenosis.	DSA (digital subtraction angiography)	Patients with carotid and intracranial stenosis.
3) Patients with lone intracranial stenosis.	MRI brain	Patients with lone intracranial stenosis.
4) Patients with no significant stenosis	brain MRA+/-CT angio on carotid and brain	Patients with no significant carotid or intracranial stenosis.
1)Patients with significant carotid stenosis only	DSA (digital subtraction angiography)	Patients with significant carotid stenosis without intracranial stenosis.
1)Patients with significant carotid stenosis only	MRI brain	Patients with significant carotid stenosis without intracranial stenosis.
2) Patients with carotid and intracranial stenosis.	Carotid duplex+/- MRA neck	Patients with carotid and intracranial stenosis.
4) Patients with no significant stenosis	Carotid duplex+/- MRA neck	Patients with no significant carotid or intracranial stenosis.
3) Patients with lone intracranial stenosis.	brain MRA+/-CT angio on carotid and brain	Patients with lone intracranial stenosis.
3) Patients with lone intracranial stenosis.	DSA (digital subtraction angiography)	Patients with lone intracranial stenosis.

Primary Outcome Measures

Name	Time	Method
National Institutes of Health Stroke Scale	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.

Secondary Outcome Measures

Name	Time	Method
Beck's Depression Inventory	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.
The modified Rankin Scale	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.

Trial Locations

Locations (1)

Mansoura University Hospital; 🇪🇬 Mansoura, Egypt