Hemodynamic in Postreperfusion Period and Functional Recovery in Acute Ischemic Stroke Patients

Acute Ischemic Stroke Clinical Trial

Official title:

The Influence of Different Hemodynamic Parameters in First 24 Hours After Intravenous Thrombolysis on Acute Ischemic Stroke Outcomes: A Randomised Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05517109
• Other study ID #: IVT-160
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2022
• Est. completion date: January 10, 2025

Study information

• Verified date: March 2024
• Source: Northern State Medical University
• Contact: Alexey Avidzba
• Phone: 9115905137
• Email: avidzba_a[@]rambler.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators are suggtesting that lower goals of systolic blood pressure after intravenous thrombolysis may reduce the risk of hemorrhagic complications and improve functional outcomes after acute ischemic stroke.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 10, 2025
• Est. primary completion date: January 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion ?riteria:

• ischemic stroke diagnosis
• performed intravenous thrombolysis (including "wake up stroke")
• systolic blood pressure >140 mmHg
• informed consent or council of physician agreement

Exclusion criteria:

• absence of informed consent or council of physician agreement
• pregnancy
• patients participainting in other clinical trial in the last 90 days
• any absolute contraindications to intravenous thrombolysis

?ompletion criteria:

• failure to achieve hemodynamic goal for 20 minutes before the start of intravenous thrombolysis
• failure to achieve hemodynamic goal for 60 minutes in first 24 hours after intravenous thrombolysis
• relative arterial hypotension (SBP <100 mmHg for 60 minutes in first 24 hours after intravenous thrombolysis)
• unfavorable effect development (e.g. seizures, angioedema)
• informed consent is retracted

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Hemorrhage
• Intracranial Hemorrhage
• Intracranial Hemorrhages
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Other:
• Hemodynamic goal including lower goal of systolic blood pressure
Different hemodynamic goals in different study arms

Locations

Country	Name	City	State
Russian Federation	City Hospital # 1 n.a. E.E. Volosevich	Arkhangelsk

Sponsors (1)

Lead Sponsor	Collaborator
Northern State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Scale score	Fucntional outcome (Modified Rankin Scale) will be assesed by telephone interview. Score from 0 to 6. Higher scores mean a worse outcome.	90 day after intravenous thrombolysis
Primary	Mortality rate		At 90 day after intravenous thrombolysis
Primary	Rate of symptomatic intracranial hemorrhage	Symptomatic intracranial hemorrhage (sICH) according to SITS-MOST study description of sICH	24 hours after intravenous thrombolysis
Primary	Rate of symptomatic intracranial hemorrhage	Symptomatic intracranial hemorrhage (sICH) according to SITS-MOST study description of sICH	7 days after intravenous thrombolysis
Secondary	Change in National Institutes of Health Stroke Scale (NIHSS)	Score form 0 to 42. Higher score indicates worse outcome	at 28 day after intravenous thrombolysis
Secondary	Rate of all Intracranial hemorrhage	Intracranial hemorrhage will be classified according to Heidelberg bleeding classification	24 hours after intravenous thrombolysis
Secondary	Rate of all Intracranial hemorrhage	Intracranial hemorrhage will be classified according to Heidelberg bleeding classification	7 days after intravenous thrombolysis
Secondary	Lengths of stay in ICU		at 90 day after intravenous thrombolysis
Secondary	Lengths of stay in hospital		at 90 day after intravenous thrombolysis
Secondary	Rate of acute kidney injury	Acute kidney injury will be assesed according to RIFLE Classification	28 day after intravenous thrombolysis or at discharge