Predictors of AIS Unfavorable Outcomes

Kafrelsheikh University

Status and phase

Completed

Phase 4

Conditions

Ischemic Stroke

Alteplase Adverse Reaction

Treatments

Drug: Alteplase

Study type

Interventional

Funder types

Other

Identifiers

NCT06058884

23091988

Details and patient eligibility

About

The investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors were predictive variables for unfavourable outcomes.

Full 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.

Enrollment

592 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.