Extracranial Carotid & Intracranial Arterial Stenosis in Ischemic Stroke
NCT ID: NCT04162587
Last Updated: 2019-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
120 participants
OBSERVATIONAL
2019-05-01
2020-08-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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1)Patients with significant carotid stenosis only
Patients with significant carotid stenosis without intracranial stenosis.
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.
2) Patients with carotid and intracranial stenosis.
Patients with carotid and intracranial stenosis.
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.
3) Patients with lone intracranial stenosis.
Patients with lone intracranial stenosis.
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.
4) Patients with no significant stenosis
Patients with no significant carotid or intracranial stenosis.
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
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Asymptomatic patients with carotid stenosis or anterior circulation stenosis discovered accidentally during investigations for further risk factors.
Exclusion Criteria
* 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.
40 Years
ALL
Yes
Sponsors
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Mansoura University Hospital
OTHER
Responsible Party
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Ahmed Esmael
Assistant Prof of Neurology
Principal Investigators
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Esmael M Ahmed, MD
Role: PRINCIPAL_INVESTIGATOR
Assistant Prof of Neurology
Locations
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Mansoura University Hospital
Al Mansurah, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Bonita R, Beaglehole R. Recovery of motor function after stroke. Stroke. 1988 Dec;19(12):1497-500. doi: 10.1161/01.str.19.12.1497.
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, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):e28-e292. doi: 10.1161/01.cir.0000441139.02102.80. Epub 2013 Dec 18. No abstract available.
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. doi: 10.1159/000094857. Epub 2006 Aug 4.
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. doi: 10.1001/archneur.60.11.1561.
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.1447-0594.2008.00509.x.
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):e002692. doi: 10.1161/JAHA.115.002692.
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. doi: 10.1161/01.STR.0000089017.90037.7A. Epub 2003 Aug 28.
Other Identifiers
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Mansoura University Hospital 4
Identifier Type: -
Identifier Source: org_study_id
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