StrokeNCT05305625
Effect of Remote Ischemic Postcondioning on Glymphatic System in Acute Stroke
A study testing remote ischemic postcondioning and standard therapy in people with Stroke, run by The Affiliated Hospital of Xuzhou Medical University.
Trial summary
Investigators aimed to investigate the changes of glymphatic function after remote ischemic postcondioning treatment in acute ischemic stroke . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- remote ischemic postcondioning and standard therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 1 May 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient was 18-80 years old;
- The NIHSS score was ≤ 25 and NIHSS > 5，Glasgow coma score ≥ 8;
- The patients were diagnosed as anterior circulation cerebral infarction and could start remote ischemic postcondioning within 24 hours after onset
- Normal to random time within 24 hours
- Written informed consent signed by patients or their families
Who cannot join
- patients receiving thrombolysis or endovascular therapy;
- modified Rankin scale (mRS) score ≥ 2 before this attack;
- other intracranial lesions, such as cerebral hemorrhage, cerebral venous disease, severe subclavian artery stenosis and other diseases involving the brain;
- Arterial blood pressure ≤ 90/60mmHg or ≥ 180/100mmHg after treatment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Remote Ischemic Postcondioning on Glymphatic System in Acute Ischemic Stroke
Investigators aimed to investigate the changes of glymphatic function after remote ischemic postcondioning treatment in acute ischemic stroke .
- Conditions
- Stroke
- Being tested
- remote ischemic postcondioning, standard therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote ischemic postcondioningProcedure or surgery
remote ischemic postcondioning twice daily, for three consecutive days，the upper arm of the lighter paralyzed side was pressurized to 200mmHg, pressurized 5min and relaxed for 5 minutes for 4 cycles as a complete remote ischemic postcondioning
standard therapyDrug
received standardized treatment
| Study group | Role | What they receive |
|---|---|---|
| standard therapy | Experimental | Patients will be treated with Guideline standard Receives: Drug: standard therapy |
| remote ischemic postcondioning and standard therapy | Experimental | Patients will be treated with remote ischemic postcondioning and Guideline standard , remote ischemic postcondioning twice a day for a total of 3 days. Receives: Procedure: remote ischemic postcondioning; Drug: standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of glial lymphatic system
The size of the vascular spaces was assessed by brain magnetic resonance of ischemic postcondioning group and standard therapy group
Measured: from baseline to 3 day
Secondary outcomes (1)
Differential expression pattern of differential proteins
Differential expression pattern of differential proteins in blood of patients with remote ischemic postcondioning group and standard therapy group
Measured: from baseline to 3 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 May 2022 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305625
- Sponsor's protocol ID
- XYFY2022-KL026
- Status last verified
- Jan 2022
- First submitted
- 25 Jan 2022
- Last updated
- 31 Mar 2022
- 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 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Ischemic Postcondioning on Glymphatic System in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05305625
- Acronym / sponsor ID
- XYFY2022-KL026
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 31 Mar 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.
Investigators aimed to investigate the changes of glymphatic function after remote ischemic postcondioning treatment in acute ischemic stroke .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard therapy | Experimental | Drug: standard therapyPatients will be treated with Guideline standard |
| remote ischemic postcondioning and standard therapy | Experimental | Procedure: remote ischemic postcondioning, Drug: standard therapyPatients will be treated with remote ischemic postcondioning and Guideline standard , remote ischemic postcondioning twice a day for a total of 3 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient was 18-80 years old;
- The NIHSS score was ≤ 25 and NIHSS > 5，Glasgow coma score ≥ 8;
- The patients were diagnosed as anterior circulation cerebral infarction and could start remote ischemic postcondioning within 24 hours after onset
- Normal to random time within 24 hours
- Written informed consent signed by patients or their families
Key exclusion criteria (4 listed)
- patients receiving thrombolysis or endovascular therapy;
- modified Rankin scale (mRS) score ≥ 2 before this attack;
- other intracranial lesions, such as cerebral hemorrhage, cerebral venous disease, severe subclavian artery stenosis and other diseases involving the brain;
- Arterial blood pressure ≤ 90/60mmHg or ≥ 180/100mmHg after treatment.
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 |
|---|---|---|
| remote ischemic postcondioningremote ischemic postcondioning twice daily, for three consecutive days，the upper arm of the lighter paralyzed side was pressurized to 200mmHg, pressurized 5min and relaxed for 5 minutes for 4 cycles as a complete remote ischemic postcondioning | Procedure or surgery | remote ischemic postcondioning and standard therapy |
| standard therapyreceived standardized treatment | Drug | remote ischemic postcondioning and standard therapy, standard therapy |
Primary outcome
Changes of glial lymphatic system
Time frame: from baseline to 3 day
The size of the vascular spaces was assessed by brain magnetic resonance of ischemic postcondioning group and standard therapy group
1 secondary outcome
Differential expression pattern of differential proteins
Time frame: from baseline to 3 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing remote ischemic postcondioning and standard therapy in people with Stroke, run by The Affiliated Hospital of Xuzhou Medical University.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Lu, MD (0086-18151865060, Yulumed@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of glial lymphatic system (time frame: from baseline to 3 day). 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 31 Mar 2022.