Predictors of AIS Unfavorable Outcomes

Ischemic Stroke Clinical Trial

Official title:

Predictors of the Unfavourable Outcomes in Acute Ischemic Stroke Patients Treated With Alteplase, a Multi-centre Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06058884
• Other study ID #: 23091988
• Status: Completed
• Phase: Phase 4
• Start date: January 3, 2022
• Est. completion date: June 29, 2023

Study information

• Verified date: October 2023
• Source: Kafrelsheikh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 592
• Est. completion date: June 29, 2023
• Est. primary completion date: June 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Alteplase
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.

Locations

Country	Name	City	State
Egypt	Kafr Elsheikh University Hospital	Kafr Ash Shaykh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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 — View 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 — View 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):66 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	90 days
Primary	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.	90 days