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Extracranial Carotid & Intracranial Arterial Stenosis in Ischemic Stroke

M

Mansoura University Hospital

Status

Unknown

Conditions

Ischemic Stroke
Carotid Stenosis

Treatments

Other: DSA (digital subtraction angiography)
Other: Carotid duplex+/- MRA neck
Other: brain MRA+/-CT angio on carotid and brain
Other: MRI brain

Study type

Observational

Funder types

Other

Identifiers

NCT04162587
Mansoura University Hospital 4

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

40+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

120 participants in 4 patient groups

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

Trial contacts and locations

1

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Central trial contact

Esmael M Ahmed, MD

Data sourced from clinicaltrials.gov

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