Extracranial Carotid & Intracranial Arterial Stenosis in Ischemic Stroke

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04162587
• Other study ID #: Mansoura University Hospital 4
• Status: Recruiting
• Start date: May 1, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: November 2019
• Source: Mansoura University Hospital
• Contact: Esmael M Ahmed, MD
• Phone: 00201000372787
• Email: deltaneuro[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carotid Stenosis
• Cerebral Infarction
• Constriction, Pathologic
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Other:
• Carotid duplex+/- MRA neck
Carotid duplex and or MRA neck
• brain MRA+/-CT angio on carotid and brain
brain MRA and or CT angiography on carotid and brain
• MRI brain
MRI brain with diffusion to detect asymptomatic stroke
• DSA (digital subtraction angiography)
DSA (digital subtraction angiography) in some cases to confirm diagnosis.

Locations

Country	Name	City	State
Egypt	Mansoura University Hospital	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (10)

Bonita R, Beaglehole R. Recovery of motor function after stroke. Stroke. 1988 Dec;19(12):1497-500. — View Citation

Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, M — View Citation

Josephson SA, Hills NK, Johnston SC. NIH Stroke Scale reliability in ratings from a large sample of clinicians. Cerebrovasc Dis. 2006;22(5-6):389-95. Epub 2006 Aug 4. — View Citation

Lee SJ, Cho SJ, Moon HS, Shon YM, Lee KH, Kim DI, Lee BB, Byun HS, Han SH, Chung CS. Combined extracranial and intracranial atherosclerosis in Korean patients. Arch Neurol. 2003 Nov;60(11):1561-4. — View Citation

Loftus CM, Harbaugh RE, Fleck JD, Biller J. Carotid occlusive disease: natural history and medical management. In: Winn HR, ed. Youman's Neurological Surgery. 6th ed. Philadelphia, PA: WB Saunders; 2011:3616.

Pinzon R, Asanti L, Sugianto, Widyo K. Risk factors of intracranial stenosis among older adults with acute ischemic stroke. unversa Medicinia 2009;28:1-7.

Rahman TT, El Gaafary MM. Montreal Cognitive Assessment Arabic version: reliability and validity prevalence of mild cognitive impairment among elderly attending geriatric clubs in Cairo. Geriatr Gerontol Int. 2009 Mar;9(1):54-61. doi: 10.1111/j.1447-0594. — View Citation

Sayed A, Ahmed S M, Abdelalim A M, Nagah M, Khairy H. Is peripheral arterial disease associated with carotid artery disease in Egyptians? A pilot study. The Egyptian Journal of Neurology, Psychiatry and neurosurgery 2016;53:12-18.

Sung YF, Lee JT, Tsai CL, Lin CC, Hsu YD, Lin JC, Chu CM, Peng GS. Risk Factor Stratification for Intracranial Stenosis in Taiwanese Patients With Cervicocerebral Stenosis. J Am Heart Assoc. 2015 Dec 15;4(12). pii: e002692. doi: 10.1161/JAHA.115.002692. — View Citation

Wong KS, Li H. Long-term mortality and recurrent stroke risk among Chinese stroke patients with predominant intracranial atherosclerosis. Stroke. 2003 Oct;34(10):2361-6. Epub 2003 Aug 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	National Institutes of Health Stroke Scale	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	The modified Rankin Scale	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
Secondary	Beck's Depression Inventory	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