Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06653946

the Predictors of Hemorrhagic Transformation Subtypes in Acute Embolic Stroke Patients

The investigators evaluated the impact of AF on different subtypes of post-alteplase hemorrhagic transformation of brain infarction.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Ischemic Stroke Alteplase Adverse Reaction Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

Investigators conducted a prospective cohort study between July 2021 and July 2023. They screened 1550 patients who presented with AIS and received alteplase and included 716 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 the patients' follow-up brain imaging to detect the subtypes of hemorrhagic transformation after receiving alteplase.

The study consisted of two distinct groups. The first group consisted of 454 patients who did not experience hemorrhagic infarction, while the second group comprised 262 patients who experienced hemorrhagic infarction.

The investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors different types of AF were predictive variables for different subtypes of post-alteplase hemorrhagic transformation of brain infarction.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The investigators enrolled individuals of both genders, aged between 18 and 75,
  • All patients had acute first-ever embolic ischemic stroke and were eligible for thrombolysis.
  • All patients had Atrial fibrillation

Exclusion criteria

  • The investigators excluded patients who had alteplase contraindications
  • The investigators excluded patients who did not receive the total dose of alteplase for any reason.
  • The investigators excluded patients who had a known history of persistent or recurrent CNS pathology (e.g., epilepsy, meningioma, multiple sclerosis)
  • 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.

Treatment and study plan

alteplase

Drug

Following the guidelines set 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

Other names: group A

Primary outcomes

  1. the rate of each AF type in the hemorrhagic infarction type 1 group compared to non HT group

    Time frame: 48 days

    The investigators will evaluate the rate of each AF type in the hemorrhagic infarction type 1 group compared to non HT group

Secondary outcomes

  1. the rate of each AF type in the hemorrhagic infarction type 2 group compared to non HT group

    Time frame: 48 hours

    The investigators will evaluate the rate of each AF type in the hemorrhagic infarction type 2 group compared to non HT group

  2. the rate of each AF type in the parenchymal haematoma type 1 group compared to non HT group

    Time frame: 48 hours

    The investigators will evaluate the rate of each AF type in the parenchymal haematoma type 1 group compared to non HT group

  3. the rate of each AF type in the parenchymal haematoma type 2 group compared to non HT group

    Time frame: 48 hours

    The investigators will evaluate the rate of each AF type in the parenchymal haematoma type 2 group compared to non HT group

Study contacts

Contact information is provided by the study sponsor or research team.

mohamed G. Zeinhom, MD

CONTACT

[email protected]

2001009606828

sherihan R. ahmed, MD

CONTACT

[email protected]

2001113432342

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

the Predictors of Different ECASS-based Hemorrhagic Transformation Subtypes in Acute Embolic Stroke Patients Treated With Alteplase

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 23, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.