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

Primary Purpose

Acute Ischemic Stroke, Intracranial Hemorrhage

Status

Recruiting

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

Hemodynamic goal including lower goal of systolic blood pressure

About this trial

This is an interventional prevention trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion сriteria:

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

Сompletion 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

Sites / Locations

City Hospital # 1 n.a. E.E. VolosevichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group. Standart care

Systolic blood pressure ≤ 160 mmHg

Arm Description

Standart hemodynamic goals: systolic blood pressure 160-185 mmHg in first 24 hours after intravenous thrombolysis

Lower hemodynamic goals: systolic blood pressure ≤ 160 mmHg in first 24 hours after intravenous thrombolysis

Outcomes

Primary Outcome Measures

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.

Mortality rate

Rate of symptomatic intracranial hemorrhage

Symptomatic intracranial hemorrhage (sICH) according to SITS-MOST study description of sICH

Rate of symptomatic intracranial hemorrhage

Symptomatic intracranial hemorrhage (sICH) according to SITS-MOST study description of sICH

Secondary Outcome Measures

Change in National Institutes of Health Stroke Scale (NIHSS)

Score form 0 to 42. Higher score indicates worse outcome

Rate of all Intracranial hemorrhage

Intracranial hemorrhage will be classified according to Heidelberg bleeding classification

Rate of all Intracranial hemorrhage

Intracranial hemorrhage will be classified according to Heidelberg bleeding classification

Lengths of stay in ICU

Lengths of stay in hospital

Rate of acute kidney injury

Acute kidney injury will be assesed according to RIFLE Classification

Full Information

NCT ID

NCT05517109

First Posted

August 6, 2022

Last Updated

August 25, 2022

Sponsor

Northern State Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05517109

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 12, 2022 (Actual)

Primary Completion Date

September 30, 2024 (Anticipated)

Study Completion Date

December 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Northern State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Ischemic Stroke, Intracranial Hemorrhage

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control group. Standart care

Arm Type

No Intervention

Arm Description

Standart hemodynamic goals: systolic blood pressure 160-185 mmHg in first 24 hours after intravenous thrombolysis

Arm Title

Systolic blood pressure ≤ 160 mmHg

Arm Type

Experimental

Arm Description

Lower hemodynamic goals: systolic blood pressure ≤ 160 mmHg in first 24 hours after intravenous thrombolysis

Intervention Type

Other

Intervention Name(s)

Hemodynamic goal including lower goal of systolic blood pressure

Intervention Description

Different hemodynamic goals in different study arms

Primary Outcome Measure Information:

Title

Modified Rankin Scale score

Description

Fucntional outcome (Modified Rankin Scale) will be assesed by telephone interview. Score from 0 to 6. Higher scores mean a worse outcome.

Time Frame

90 day after intravenous thrombolysis

Title

Mortality rate

Time Frame

At 90 day after intravenous thrombolysis

Title

Rate of symptomatic intracranial hemorrhage

Description

Symptomatic intracranial hemorrhage (sICH) according to SITS-MOST study description of sICH

Time Frame

24 hours after intravenous thrombolysis

Title

Rate of symptomatic intracranial hemorrhage

Description

Symptomatic intracranial hemorrhage (sICH) according to SITS-MOST study description of sICH

Time Frame

7 days after intravenous thrombolysis

Secondary Outcome Measure Information:

Title

Change in National Institutes of Health Stroke Scale (NIHSS)

Description

Score form 0 to 42. Higher score indicates worse outcome

Time Frame

at 28 day after intravenous thrombolysis

Title

Rate of all Intracranial hemorrhage

Description

Intracranial hemorrhage will be classified according to Heidelberg bleeding classification

Time Frame

24 hours after intravenous thrombolysis

Title

Rate of all Intracranial hemorrhage

Description

Intracranial hemorrhage will be classified according to Heidelberg bleeding classification

Time Frame

7 days after intravenous thrombolysis

Title

Lengths of stay in ICU

Time Frame

at 90 day after intravenous thrombolysis

Title

Lengths of stay in hospital

Time Frame

at 90 day after intravenous thrombolysis

Title

Rate of acute kidney injury

Description

Acute kidney injury will be assesed according to RIFLE Classification

Time Frame

28 day after intravenous thrombolysis or at discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion сriteria: 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 Сompletion 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alexey Avidzba

Phone

9115905137

Ext

avidzba_a@rambler.ru

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mikhail Kirov, PhD

Organizational Affiliation

Northen state medical university

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Alexey Avidzba

Organizational Affiliation

Northen state medical university

Official's Role

Study Chair

Facility Information:

Facility Name

City Hospital # 1 n.a. E.E. Volosevich

City

Arkhangelsk

ZIP/Postal Code

163000

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mikhail Kirov, PhD

mikhail_kirov@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All IPD that underlie results in a publication

Learn more about this trial

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

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