Acute Ischemic StrokeNCT05517109
Hemodynamic in Postreperfusion Period and Functional Recovery in Acute Ischemic Stroke Patients
A study testing Hemodynamic goal including lower goal of systolic blood pressure in people with Acute Ischemic Stroke and Intracranial Hemorrhage, run by Northern State Medical University at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Intracranial Hemorrhage
- What is being tested?
- Hemodynamic goal including lower goal of systolic blood pressure
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteRussia
- Study dates
- 12 Mar 2022to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ischemic stroke diagnosis
- performed intravenous thrombolysis (including "wake up stroke")
- systolic blood pressure >140 mmHg
- informed consent or council of physician agreement
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Different Hemodynamic Parameters in First 24 Hours After Intravenous Thrombolysis on Acute Ischemic Stroke Outcomes: a Randomised Clinical Trial
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.
- Conditions
- Acute Ischemic Stroke, Intracranial Hemorrhage
- Being tested
- Hemodynamic goal including lower goal of systolic blood pressure
- Medical subject headings
- Ischemic Stroke, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemodynamic goal including lower goal of systolic blood pressureOther
Different hemodynamic goals in different study arms
| Study group | Role | What they receive |
|---|---|---|
| Control group. Standart care | No intervention | Standart hemodynamic goals: systolic blood pressure 160-185 mmHg in first 24 hours after intravenous thrombolysis |
| Systolic blood pressure ≤ 160 mmHg | Experimental | Lower hemodynamic goals: systolic blood pressure ≤ 160 mmHg in first 24 hours after intravenous thrombolysis Receives: Other: Hemodynamic goal including lower goal of systolic blood pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 day after intravenous thrombolysis
Mortality rate
Measured: At 90 day after intravenous thrombolysis
Rate of symptomatic intracranial hemorrhage
Symptomatic intracranial hemorrhage (sICH) according to SITS-MOST study description of sICH
Measured: 24 hours after intravenous thrombolysis
Rate of symptomatic intracranial hemorrhage
Symptomatic intracranial hemorrhage (sICH) according to SITS-MOST study description of sICH
Measured: 7 days after intravenous thrombolysis
Secondary outcomes (6)
Change in National Institutes of Health Stroke Scale (NIHSS)
Score form 0 to 42. Higher score indicates worse outcome
Measured: at 28 day after intravenous thrombolysis
Rate of all Intracranial hemorrhage
Intracranial hemorrhage will be classified according to Heidelberg bleeding classification
Measured: 24 hours after intravenous thrombolysis
Rate of all Intracranial hemorrhage
Intracranial hemorrhage will be classified according to Heidelberg bleeding classification
Measured: 7 days after intravenous thrombolysis
Lengths of stay in ICU
Measured: at 90 day after intravenous thrombolysis
Lengths of stay in hospital
Measured: at 90 day after intravenous thrombolysis
Rate of acute kidney injury
Acute kidney injury will be assesed according to RIFLE Classification
Measured: 28 day after intravenous thrombolysis or at discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start12 Mar 2022
- Primary completion30 Apr 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mikhail Kirov, PhD, Study director, Northen state medical universityAlexey Avidzba, Study chair, Northen state medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517109
- Sponsor's protocol ID
- IVT-160
- Status last verified
- Oct 2024
- First submitted
- 6 Aug 2022
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Different Hemodynamic Parameters in First 24 Hours After Intravenous Thrombolysis on Acute Ischemic Stroke Outcomes: a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT05517109
- Acronym / sponsor ID
- IVT-160
- Conditions
- Acute Ischemic Stroke, Intracranial Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Northern State Medical UniversityUniversity, hospital or other
- Study start
- 12 Mar 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group. Standart care | No intervention | –Standart hemodynamic goals: systolic blood pressure 160-185 mmHg in first 24 hours after intravenous thrombolysis |
| Systolic blood pressure ≤ 160 mmHg | Experimental | Other: Hemodynamic goal including lower goal of systolic blood pressureLower hemodynamic goals: systolic blood pressure ≤ 160 mmHg in first 24 hours after intravenous thrombolysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ischemic stroke diagnosis
- performed intravenous thrombolysis (including "wake up stroke")
- systolic blood pressure >140 mmHg
- informed consent or council of physician agreement
Key exclusion criteria (10 listed)
- 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
- failure to achieve hemodynamic goal for 20 minutes before the start of intravenous thrombolysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemodynamic goal including lower goal of systolic blood pressureDifferent hemodynamic goals in different study arms | Other | Systolic blood pressure ≤ 160 mmHg |
Primary outcome
Modified Rankin Scale score
Time frame: 90 day after intravenous thrombolysis
Fucntional outcome (Modified Rankin Scale) will be assesed by telephone interview. Score from 0 to 6. Higher scores mean a worse outcome.
Mortality rate
Time frame: At 90 day after intravenous thrombolysis
Rate of symptomatic intracranial hemorrhage
Time frame: 24 hours after intravenous thrombolysis
Symptomatic intracranial hemorrhage (sICH) according to SITS-MOST study description of sICH
Rate of symptomatic intracranial hemorrhage
Time frame: 7 days after intravenous thrombolysis
Symptomatic intracranial hemorrhage (sICH) according to SITS-MOST study description of sICH
6 secondary outcomes
Change in National Institutes of Health Stroke Scale (NIHSS)
Time frame: at 28 day after intravenous thrombolysis
Rate of all Intracranial hemorrhage
Time frame: 24 hours after intravenous thrombolysis
Rate of all Intracranial hemorrhage
Time frame: 7 days after intravenous thrombolysis
Lengths of stay in ICU
Time frame: at 90 day after intravenous thrombolysis
Lengths of stay in hospital
Time frame: at 90 day after intravenous thrombolysis
Rate of acute kidney injury
Time frame: 28 day after intravenous thrombolysis or at discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikhail Kirov, PhD study director
Northen state medical university
Alexey Avidzba study chair
Northen state medical university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemodynamic goal including lower goal of systolic blood pressure in people with Acute Ischemic Stroke and Intracranial Hemorrhage, run by Northern State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale score (time frame: 90 day after intravenous thrombolysis). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.