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Predictors of AIS Unfavorable Outcomes

Primary Purpose

Ischemic Stroke, Alteplase Adverse Reaction

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Alteplase
Sponsored by
Kafrelsheikh University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring alteplase, acute ischemic stroke, Egypt, Saudi Arabia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The investigators enrolled individuals of both genders, aged between 18 and 75, who presented with acute first-ever ischemic stroke and were eligible for thrombolysis. Exclusion Criteria: The investigators excluded patients who had not been followed up on for 90 days after enrollment, Those with alteplase contraindications or did not receive the total dose of alteplase due to any reason were excluded The investigators excluded patients with a known history of persistent or recurrent CNS pathology (e.g., epilepsy, meningioma, multiple sclerosis, history of head trauma with a residual neurological deficit). The investigators excluded patients who had recurrent ischemic stroke diagnosed by appropriate clinical history and/or MRI brain findings. The investigators excluded patients with symptoms of major organ failure, active malignancies, or an acute myocardial infarction within the previous six weeks. The investigators also excluded pregnant and lactating patients with stroke due to venous thrombosis and stroke following cardiac arrest.

Sites / Locations

  • Kafr Elsheikh University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

favourbale outcome group

unfavourbale outcome group

Arm Description

Four hundred fifty-six acute ischemic stroke (AIS) patients who had modified Rankin scale (mRS) two or less after 90 days of ischemic stroke.

One hundred thirty-six acute ischemic stroke (AIS) patients who had modified Rankin scale (mRS) three or more after 90 days of ischemic stroke.

Outcomes

Primary Outcome Measures

modified Rankin scale (mRS)
To detect the score, investigators assessed modified rankin scale (mRS) after 90 days via a 10-minute telephone interview with patients or their primary caregivers. mRS two or less was considered a favourable outcome. mRS is a scale that assessed the outcome of stroke patients and its score ranged from zero to six. the lower the values the better the outcome
predictors of the unfavourable outcomes
The investigators employed univariate and multivariate Logistic regression analysis to assess the ability of patients' characteristics and risk factors to predict the unfavourable outcomes after 90 days of acute ischemic stroke.

Secondary Outcome Measures

Full Information

First Posted
September 22, 2023
Last Updated
October 5, 2023
Sponsor
Kafrelsheikh University
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1. Study Identification

Unique Protocol Identification Number
NCT06058884
Brief Title
Predictors of AIS Unfavorable Outcomes
Official Title
Predictors of the Unfavourable Outcomes in Acute Ischemic Stroke Patients Treated With Alteplase, a Multi-centre Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 3, 2022 (Actual)
Primary Completion Date
June 3, 2023 (Actual)
Study Completion Date
June 29, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors were predictive variables for unfavourable outcomes.
Detailed Description
Investigators conducted a prospective cohort study between January 2022 and June 2023 and screened 1184 patients presented with AIS and received alteplase and included 592 AIS patients who met the inclusion criteria and were diagnosed based on a thorough clinical assessment, including a detailed medical history, physical examination and specific brain imaging results and treated with alteplase within four and half hours of stroke onset. The investigators assessed mRS after 90 days via a 10-minute telephone interview. With patients or their primary caregivers to detect the score, all of our patients had baseline mRS of zero. mRS two or less was considered a favourable outcome The study consisted of two distinct groups. The first group consisted of 456 patients who experienced favourable outcomes, while the second group comprised 136 patients who experienced unfavourable outcomes. The investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors were predictive variables for unfavourable outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Alteplase Adverse Reaction
Keywords
alteplase, acute ischemic stroke, Egypt, Saudi Arabia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
The study consisted of two distinct groups. The first group consisted of 456 patients who experienced favourable outcomes (mRS two or less), while the second group comprised 136 patients who experienced unfavourable outcomes (mRS more than two).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
592 (Actual)

8. Arms, Groups, and Interventions

Arm Title
favourbale outcome group
Arm Type
Active Comparator
Arm Description
Four hundred fifty-six acute ischemic stroke (AIS) patients who had modified Rankin scale (mRS) two or less after 90 days of ischemic stroke.
Arm Title
unfavourbale outcome group
Arm Type
Active Comparator
Arm Description
One hundred thirty-six acute ischemic stroke (AIS) patients who had modified Rankin scale (mRS) three or more after 90 days of ischemic stroke.
Intervention Type
Drug
Intervention Name(s)
Alteplase
Intervention Description
Following the guidelines set forth by the American Heart Association/American Stroke Association (AHA/ASA), inclusion and exclusion criteria for alteplase were established; 0.9 mg/kg of alteplase up to a maximum dose of 90 mg was administered intravenously to eligible individuals within 4.5 hours of the beginning of their clinical manifestations (10% bolus, 90% infusion in 1 hour). After receiving IV-alteplase, all patients continued their management and rehabilitation in the stroke unit.
Primary Outcome Measure Information:
Title
modified Rankin scale (mRS)
Description
To detect the score, investigators assessed modified rankin scale (mRS) after 90 days via a 10-minute telephone interview with patients or their primary caregivers. mRS two or less was considered a favourable outcome. mRS is a scale that assessed the outcome of stroke patients and its score ranged from zero to six. the lower the values the better the outcome
Time Frame
90 days
Title
predictors of the unfavourable outcomes
Description
The investigators employed univariate and multivariate Logistic regression analysis to assess the ability of patients' characteristics and risk factors to predict the unfavourable outcomes after 90 days of acute ischemic stroke.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The investigators enrolled individuals of both genders, aged between 18 and 75, who presented with acute first-ever ischemic stroke and were eligible for thrombolysis. Exclusion Criteria: The investigators excluded patients who had not been followed up on for 90 days after enrollment, Those with alteplase contraindications or did not receive the total dose of alteplase due to any reason were excluded The investigators excluded patients with a known history of persistent or recurrent CNS pathology (e.g., epilepsy, meningioma, multiple sclerosis, history of head trauma with a residual neurological deficit). The investigators excluded patients who had recurrent ischemic stroke diagnosed by appropriate clinical history and/or MRI brain findings. The investigators excluded patients with symptoms of major organ failure, active malignancies, or an acute myocardial infarction within the previous six weeks. The investigators also excluded pregnant and lactating patients with stroke due to venous thrombosis and stroke following cardiac arrest.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohamed G. Zeinhom, MD,PHD
Organizational Affiliation
neurology department kafr el-sheikh university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kafr Elsheikh University Hospital
City
Kafr Ash Shaykh
ZIP/Postal Code
33511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All the data supporting this research's findings may be available from the principal investigator, Mohamed G. Zeinhom, upon reasonable request.
Citations:
PubMed Identifier
16731270
Citation
Lopez AD, Mathers CD, Ezzati M, Jamison DT, Murray CJ. Global and regional burden of disease and risk factors, 2001: systematic analysis of population health data. Lancet. 2006 May 27;367(9524):1747-57. doi: 10.1016/S0140-6736(06)68770-9.
Results Reference
result
PubMed Identifier
34515113
Citation
Zeinhom MG, Aref HM, El-Khawas H, Roushdy TM, Shokri HM, Elbassiouny A. A pilot study of the ticagrelor role in ischemic stroke secondary prevention. Eur Neurol. 2022;85(1):50-55. doi: 10.1159/000518786. Epub 2021 Aug 30.
Results Reference
result
PubMed Identifier
12221155
Citation
Bruno A, Levine SR, Frankel MR, Brott TG, Lin Y, Tilley BC, Lyden PD, Broderick JP, Kwiatkowski TG, Fineberg SE; NINDS rt-PA Stroke Study Group. Admission glucose level and clinical outcomes in the NINDS rt-PA Stroke Trial. Neurology. 2002 Sep 10;59(5):669-74. doi: 10.1212/wnl.59.5.669.
Results Reference
result
PubMed Identifier
36446950
Citation
Aref HM, El-Khawas H, Elbassiouny A, Shokri HM, Zeinhom MG, Roushdy TM. A randomized pilot study of the efficacy and safety of loading ticagrelor in acute ischemic stroke. Neurol Sci. 2023 Feb;44(2):765-771. doi: 10.1007/s10072-022-06525-7. Epub 2022 Nov 30.
Results Reference
result
PubMed Identifier
35854172
Citation
Ahmed SR, Mohamed AAM, Salem HH, Helmy S, Moustafa RR, Borham SMF. Association of white matter hyperintensities with migraine phenotypes and response to treatment. Acta Neurol Belg. 2023 Oct;123(5):1725-1733. doi: 10.1007/s13760-022-02015-x. Epub 2022 Jul 19.
Results Reference
result

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Predictors of AIS Unfavorable Outcomes

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