Predictors of AIS Unfavorable Outcomes

Phase 4

Completed

• Conditions: Ischemic Stroke; Alteplase Adverse Reaction
• Interventions: Drug: Alteplase

• Registration Number: NCT06058884
• Lead Sponsor: Kafrelsheikh University

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.

Study Timeline

• Study Start: 2022-01-03
• Primary Completion: 2023-06-03
• Study Completion: 2023-06-29
• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2023-09-22
• Study First Posted: 2023-09-28
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 592

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
favourbale outcome group	Alteplase	Four hundred fifty-six acute ischemic stroke (AIS) patients who had modified Rankin scale (mRS) two or less after 90 days of ischemic stroke.
unfavourbale outcome group	Alteplase	One hundred thirty-six acute ischemic stroke (AIS) patients who had modified Rankin scale (mRS) three or more after 90 days of ischemic stroke.

Primary Outcome Measures

Name	Time	Method
predictors of the unfavourable outcomes	90 days	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.
modified Rankin scale (mRS)	90 days	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

Trial Locations

Locations (1)

Kafr Elsheikh University Hospital; 🇪🇬 Kafr Ash Shaykh, Egypt