NCT04162587

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

11 months

First QC Date

November 11, 2019

Last Update Submit

November 16, 2019

Conditions

Ischemic StrokeCarotid Stenosis

Keywords

Ischemic Strokecarotid stenosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The modified Rankin Scale

    24 hours

  • Beck's Depression Inventory

    24hours

Study Arms (4)

1)Patients with significant carotid stenosis only

Patients with significant carotid stenosis without intracranial stenosis.

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

2) Patients with carotid and intracranial stenosis.

Patients with carotid and intracranial stenosis.

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

3) Patients with lone intracranial stenosis.

Patients with lone intracranial stenosis.

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

4) Patients with no significant stenosis

Patients with no significant carotid or intracranial stenosis.

Other: Carotid duplex+/- MRA neckOther: brain MRA+/-CT angio on carotid and brainOther: MRI brain

Interventions

Carotid duplex+/- MRA neckOTHER

Carotid duplex and or MRA neck

1)Patients with significant carotid stenosis only2) 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 brainOTHER

brain MRA and or CT angiography on carotid and brain

1)Patients with significant carotid stenosis only2) Patients with carotid and intracranial stenosis.3) Patients with lone intracranial stenosis.4) Patients with no significant stenosis
MRI brainOTHER

MRI brain with diffusion to detect asymptomatic stroke

1)Patients with significant carotid stenosis only2) Patients with carotid and intracranial stenosis.3) Patients with lone intracranial stenosis.4) Patients with no significant stenosis
DSA (digital subtraction angiography)OTHER

DSA (digital subtraction angiography) in some cases to confirm diagnosis.

1)Patients with significant carotid stenosis only2) Patients with carotid and intracranial stenosis.3) Patients with lone intracranial stenosis.

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Egypt

RECRUITING

Related Publications (10)

  • 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.

    PMID: 3201508RESULT

  • 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.

    PMID: 24352519RESULT

  • 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.

    PMID: 16888381RESULT

  • 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.

    PMID: 14623728RESULT

  • 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.

    RESULT

  • 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.

    RESULT

  • 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.

    PMID: 19260980RESULT

  • 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.

    RESULT

  • 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.

    PMID: 26672078RESULT

  • 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.

    PMID: 12947158RESULT

MeSH Terms

Conditions

Ischemic StrokeCarotid Stenosis

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCarotid Artery DiseasesArterial Occlusive Diseases

Study Officials

  • Esmael M Ahmed, MD

    Assistant Prof of Neurology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Esmael M Ahmed, MD

CONTACT

00201000372787deltaneuro@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Prof of Neurology

Study Record Dates

First Submitted

November 11, 2019

First Posted

November 14, 2019

Study Start

May 1, 2019

Primary Completion

April 1, 2020

Study Completion

August 1, 2020

Last Updated

November 19, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)