Ischemic StrokeNCT04162587
Extracranial Carotid & Intracranial Arterial Stenosis in Ischemic Stroke
An observational study of Ischemic Stroke and Carotid Stenosis, run by Mansoura University Hospital at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke, Carotid Stenosis
- What is being tested?
- Carotid duplex+/- MRA neck, brain MRA+/-CT angio on carotid and brain and MRI brain
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2019to 1 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University Hospital
Al Mansurah
Esmael M Ahmed, MD, 00201000382898, deltaneuro@yahoo.com
About this study
Official title: Association Between Extracranial Carotid & Intracranial Arterial Stenosis in Ischemic Stroke Patients: Predictors & Outcome
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.
Read the 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:
- Patients with significant carotid stenosis without intracranial stenosis.
- Patients with carotid and intracranial stenosis.
- Patients with lone intracranial stenosis.
- 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
- Ischemic Stroke, Carotid Stenosis
- Being tested
- Carotid duplex+/- MRA neck, brain MRA+/-CT angio on carotid and brain, MRI brain, DSA (digital subtraction angiography)
- Keywords
- Ischemic Stroke, carotid stenosis
- Medical subject headings
- Ischemic Stroke, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid duplex+/- MRA neckOther
Carotid duplex and or MRA neck
brain MRA+/-CT angio on carotid and brainOther
brain MRA and or CT angiography on carotid and brain
MRI brainOther
MRI brain with diffusion to detect asymptomatic stroke
DSA (digital subtraction angiography)Other
DSA (digital subtraction angiography) in some cases to confirm diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| 1)Patients with significant carotid stenosis only | Patients with significant carotid stenosis without intracranial stenosis. Receives: Other: Carotid duplex+/- MRA neck; Other: brain MRA+/-CT angio on carotid and brain; Other: MRI brain; Other: DSA (digital subtraction angiography) | |
| 2) Patients with carotid and intracranial stenosis. | Patients with carotid and intracranial stenosis. Receives: Other: Carotid duplex+/- MRA neck; Other: brain MRA+/-CT angio on carotid and brain; Other: MRI brain; Other: DSA (digital subtraction angiography) | |
| 3) Patients with lone intracranial stenosis. | Patients with lone intracranial stenosis. Receives: Other: Carotid duplex+/- MRA neck; Other: brain MRA+/-CT angio on carotid and brain; Other: MRI brain; Other: DSA (digital subtraction angiography) | |
| 4) Patients with no significant stenosis | Patients with no significant carotid or intracranial stenosis. Receives: Other: Carotid duplex+/- MRA neck; Other: brain MRA+/-CT angio on carotid and brain; Other: MRI brain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (2)
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.
Measured: 24 hours
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.
Measured: 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start1 May 2019
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Esmael, Mansoura University Hospital
- Investigators
- Esmael M Ahmed, MD, Principal investigator, Assistant Prof of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162587
- Sponsor's protocol ID
- Mansoura University Hospital 4
- Status last verified
- Nov 2019
- First submitted
- 11 Nov 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 3201508Go 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.
PubMed 24352519Josephson 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.
PubMed 16888381Lee 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.
PubMed 14623728Loftus 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.
PubMed 19260980Sayed 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.
PubMed 26672078Wong 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.
PubMed 12947158
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Extracranial Carotid & Intracranial Arterial Stenosis in Ischemic Stroke Patients: Predictors & Outcome
- ClinicalTrials.gov ID
- NCT04162587
- Acronym / sponsor ID
- Mansoura University Hospital 4
- Conditions
- Ischemic Stroke, Carotid Stenosis
- Keywords
- Ischemic Stroke, carotid stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mansoura University HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Patients with significant carotid stenosis without intracranial stenosis.
- Patients with carotid and intracranial stenosis.
- Patients with lone intracranial stenosis.
- 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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1)Patients with significant carotid stenosis only | – | Other: Carotid duplex+/- MRA neck, Other: brain MRA+/-CT angio on carotid and brain, Other: MRI brain, Other: DSA (digital subtraction angiography)Patients with significant carotid stenosis without intracranial stenosis. |
| 2) Patients with carotid and intracranial stenosis. | – | Other: Carotid duplex+/- MRA neck, Other: brain MRA+/-CT angio on carotid and brain, Other: MRI brain, Other: DSA (digital subtraction angiography)Patients with carotid and intracranial stenosis. |
| 3) Patients with lone intracranial stenosis. | – | Other: Carotid duplex+/- MRA neck, Other: brain MRA+/-CT angio on carotid and brain, Other: MRI brain, Other: DSA (digital subtraction angiography)Patients with lone intracranial stenosis. |
| 4) Patients with no significant stenosis | – | Other: Carotid duplex+/- MRA neck, Other: brain MRA+/-CT angio on carotid and brain, Other: MRI brainPatients with no significant carotid or intracranial stenosis. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotid duplex+/- MRA neckCarotid duplex and or MRA neck | Other | 1)Patients with significant carotid stenosis only, 2) Patients with carotid and intracranial stenosis., 3) Patients with lone intracranial stenosis., 4) Patients with no significant stenosis |
| brain MRA+/-CT angio on carotid and brainbrain MRA and or CT angiography on carotid and brain | Other | 1)Patients with significant carotid stenosis only, 2) Patients with carotid and intracranial stenosis., 3) Patients with lone intracranial stenosis., 4) Patients with no significant stenosis |
| MRI brainMRI brain with diffusion to detect asymptomatic stroke | Other | 1)Patients with significant carotid stenosis only, 2) Patients with carotid and intracranial stenosis., 3) Patients with lone intracranial stenosis., 4) Patients with no significant stenosis |
| DSA (digital subtraction angiography)DSA (digital subtraction angiography) in some cases to confirm diagnosis. | Other | 1)Patients with significant carotid stenosis only, 2) Patients with carotid and intracranial stenosis., 3) Patients with lone intracranial stenosis. |
Primary outcome
National Institutes of Health Stroke Scale
Time frame: 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.
2 secondary outcomes
The modified Rankin Scale
Time frame: 24 hours
Beck's Depression Inventory
Time frame: 24hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Results publication: PubMed 3201508Bonita R, Beaglehole R. Recovery of motor function after stroke. Stroke. 1988 Dec;19(12):1497-500. doi: 10.1161/01.str.19.12.1497.
- Results publication: PubMed 24352519Go 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.
- Results publication: PubMed 16888381Josephson 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.
- Results publication: PubMed 14623728Lee 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.
- Results publicationLoftus 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.
- Results publicationPinzon R, Asanti L, Sugianto, Widyo K. Risk factors of intracranial stenosis among older adults with acute ischemic stroke. unversa Medicinia 2009;28:1-7.
- Results publication: PubMed 19260980Rahman 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.
- Results publicationSayed 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.
- Results publication: PubMed 26672078Sung 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.
- Results publication: PubMed 12947158Wong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esmael M Ahmed, MD principal investigator
Assistant Prof of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Carotid Stenosis, run by Mansoura University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esmael M Ahmed, MD (00201000372787, deltaneuro@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Institutes of Health Stroke Scale (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04162587, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.