Acute Ischemic StrokeNCT04980651
Safety and Efficacy of Remote Ischemic Conditioning for Acute Ischemic Stroke
A study testing Remote ischemic conditioning in people with Acute Ischemic Stroke, run by Yi Yang at 1 site in China.
Trial summary
The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning for 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
- What is being tested?
- Remote ischemic conditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,210 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 1 Oct 2025
- 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
- 1) Age≥18 years, regardless of sex.
- 2) Patients with clinically definite diagnosis of acute ischemic stroke and able to commence RIC treatment within 72 hours of stroke onset.
- 3) Baseline NIHSS ≥ 4, ≤ 24.
- 4) Baseline mRS ≤ 2;
- 5) Signed and dated informed consent is obtained.
Who cannot join
- 1) Patients who undergo thrombolytic therapy or endovascular treatment.
- 2) The patients who had the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture, or vascular injury in the upper limb. Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc.
- 3) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumors,s and other diseases involving the brain.
- 4) Pregnant or lactating women.
- 5) Previous remote ischemic conditioning therapy or similar treatment.
- 6) Severe hepatic and renal dysfunction.
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- 7) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons.
- 8) Unwilling to be followed up or treated for poor compliance.
- 9) He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission.
- 10) Other conditions that the researchers think are not suitable for the group.
Trial locations and contacts
1 site in 1 country.
Zhenni Guo, MD, PhD contact
China1 site, 1 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130000
Yi Yang, MD,PHD, doctor_yangyi@163.com
About this study
Official title: Safety and Efficacy of Remote Ischemic Conditioning for Acute Ischemic Stroke: A Multicenter, Randomized, Parallel-controlled Clinical Trial
The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning for acute ischemic stroke.
Read the detailed description
In this study, 2210 cases of ischemic stroke in 72 hours were included in 10 centers in China according to the principle of random, and parallel control. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 7 consecutive days. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day for 7 consecutive days. Two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning in treating acute ischemic stroke.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Remote ischemic conditioning, Sham remote ischemic conditioning
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioningProcedure or surgery
Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg.
Sham remote ischemic conditioningProcedure or surgery
Sham remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg.
| Study group | Role | What they receive |
|---|---|---|
| RIC+Standard medical treatment | Active comparator | Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 consecutive days. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014. Receives: Procedure: Remote ischemic conditioning |
| Sham RIC+Standard medical treatment | Placebo comparator | Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 consecutive days. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014. Receives: Procedure: Sham remote ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with modified Rankin Scale (mRS) Score 0-2.
Proportion of patients with modified Rankin Scale (mRS) Score 0-2. Ranged from 0 to 6, a low value represents a better outcome.
Measured: 3 months
Secondary outcomes (5)
National Institute of Health stroke scale (NIHSS) at 7 days, 30±3 days, 90±3 days from onset.
National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days, 30±3 days, 90±3 days from onset. Ranged from 0 to 42, a low value represents a better outcome.
Measured: 7days, 30±3 days, 90±3 days
modified Rankin Scale (mRS) Score at 7 days, 30±3 days, 90±3 days from onset.
modified Rankin Scale (mRS) at 24 hours, 7 days, 30±3 days, 90±3 days from onset. Ranged from 0 to 6, a low value represents a better outcome.
Measured: 7days, 30±3 days, 90±3 days
Barthel Index (BI) at 7 days, 30±3 days, 90±3 days from onset.
Barthel Index (BI) at 7 days, 30±3 days, 90±3 days from onset. Ranged from 0 to 100, a high value represents a better outcome.
Measured: 7days, 30±3 days, 90±3 days
Proportion of patients with hemorrhagic transformation during hospitalization.
Proportion of patients with hemorrhagic transformation during hospitalization.
Measured: 7 days
Frequency of adverse events during follow-up.
Severe adverse events through day-90 after the onset of acute ischemic stroke.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Jul 2021
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Yang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980651
- Sponsor's protocol ID
- SERIC
- Status last verified
- Feb 2024
- First submitted
- 13 Jul 2021
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Remote Ischemic Conditioning for Acute Ischemic Stroke: A Multicenter, Randomized, Parallel-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04980651
- Acronym / sponsor ID
- SERIC
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,210 participants (estimated)
- Lead sponsor
- Yi YangUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 28 Jul 2021 (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 purpose of this study is to determine the efficacy and safety of remote ischemic conditioning for acute ischemic stroke.
Detailed description
In this study, 2210 cases of ischemic stroke in 72 hours were included in 10 centers in China according to the principle of random, and parallel control. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 7 consecutive days. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day for 7 consecutive days. Two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning in treating acute ischemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC+Standard medical treatment | Active comparator | Procedure: Remote ischemic conditioningRemote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 consecutive days. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014. |
| Sham RIC+Standard medical treatment | Placebo comparator | Procedure: Sham remote ischemic conditioningRemote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 consecutive days. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1) Age≥18 years, regardless of sex.
- 2) Patients with clinically definite diagnosis of acute ischemic stroke and able to commence RIC treatment within 72 hours of stroke onset.
- 3) Baseline NIHSS ≥ 4, ≤ 24.
- 4) Baseline mRS ≤ 2;
- 5) Signed and dated informed consent is obtained.
Key exclusion criteria (10 listed)
- 1) Patients who undergo thrombolytic therapy or endovascular treatment.
- 2) The patients who had the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture, or vascular injury in the upper limb. Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc.
- 3) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumors,s and other diseases involving the brain.
- 4) Pregnant or lactating women.
- 5) Previous remote ischemic conditioning therapy or similar 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 conditioningRemote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. | Procedure or surgery | RIC+Standard medical treatment |
| Sham remote ischemic conditioningSham remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. | Procedure or surgery | Sham RIC+Standard medical treatment |
Primary outcome
Proportion of patients with modified Rankin Scale (mRS) Score 0-2.
Time frame: 3 months
Proportion of patients with modified Rankin Scale (mRS) Score 0-2. Ranged from 0 to 6, a low value represents a better outcome.
5 secondary outcomes
National Institute of Health stroke scale (NIHSS) at 7 days, 30±3 days, 90±3 days from onset.
Time frame: 7days, 30±3 days, 90±3 days
modified Rankin Scale (mRS) Score at 7 days, 30±3 days, 90±3 days from onset.
Time frame: 7days, 30±3 days, 90±3 days
Barthel Index (BI) at 7 days, 30±3 days, 90±3 days from onset.
Time frame: 7days, 30±3 days, 90±3 days
Proportion of patients with hemorrhagic transformation during hospitalization.
Time frame: 7 days
Frequency of adverse events during follow-up.
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
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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.
Zhenni Guo, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic conditioning in people with Acute Ischemic Stroke, run by Yi Yang at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 2 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 China. 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. Some participants in this study may receive a placebo. 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 Yi Yang, MD, PhD (0086-13756661217, doctor_yangyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with modified Rankin Scale (mRS) Score 0-2. (time frame: 3 months). 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 2 Oct 2024.