Clinical trial NCT06653946: the Predictors of Hemorrhagic Transformation Subtypes in Acute Embolic Stroke Patients
Official title: the Predictors of Different ECASS-based Hemorrhagic Transformation Subtypes in Acute Embolic Stroke Patients Treated With Alteplase
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Ischemic Stroke
Alteplase Adverse Reaction
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 716
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study consisted of two distinct groups. The first group comprised 454 patients who did not experience hemorrhagic infarction, while the second group comprised 252 patients who experienced hemorrhagic infarction.
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: the rate of each AF type in the hemorrhagic infarction type 1 group compared to non HT group
timeFrame: 48 days
Secondary outcomes:
measure: the rate of each AF type in the hemorrhagic infarction type 2 group compared to non HT group
timeFrame: 48 hours
measure: the rate of each AF type in the parenchymal haematoma type 1 group compared to non HT group
timeFrame: 48 hours
measure: the rate of each AF type in the parenchymal haematoma type 2 group compared to non HT group
timeFrame: 48 hours
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafr Elsheikh University Hospital
Study officials:
affiliation: neurology department kafr el-sheikh university
name: mohamed G. Zeinhom, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.