Acute Ischemic StrokeNCT04977869
Safety and Efficacy Study of Remote Ischemic Conditioning Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation
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 patients of acute ischemic stroke who underwent endovascular thrombectomy due to large vessel occlusion of anterior circulation. 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
- 498 participants
- Where
- 1 siteChina
- Study dates
- 26 Aug 2021to 16 Sep 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
- 1) Age ≥ 18 years, male or female
- 2) Diagnosis of acute ischemic stroke within 24 hours of symptom onset and underwent endovascular thrombectomy (EVT) adhering to current guidelines for large vessel occlusion in the anterior circulation (confirmed by computed tomography angiography or digital subtraction angiography)
- 3) Pre-EVT NIHSS ≥ 6
- 4) Premorbid mRS ≤ 2
- 5) Written informed consent obtained from the patient or legally responsible person
Who cannot join
- 1) Contraindication of endovascular thrombectomy
- 2) Contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture, or vascular injury in the upper limb, acute or subacute venous thrombosis, arterial occlusive disease, and subclavian steal syndrome
- 3) Head CT showing cerebral hernia and midline displacement
- 4) Pregnancy or lactation
- 5) Previous remote ischemic conditioning therapy or similar treatment
- 6) Severe hepatic and renal dysfunction
Show all 10Show fewer
- 7) Life expectancy of less than 3 months or inability to complete the study for other reasons
- 8) Unwilling to be followed up or poor compliance
- 9) Current or past participation in other clinical research, or participation in this study within 3 months prior to admission
- 10) Other conditions that the researchers think make the patient unsuitable for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy Study of Remote Ischemic Conditioning Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation: A Multicenter, Randomized, Parallel-controlled Clinical Trial
The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning for patients of acute ischemic stroke who underwent endovascular thrombectomy due to large vessel occlusion of anterior circulation.
Read the detailed description
In this study, 498 cases of ischemic stroke who undergo endovascular thrombectomy within 24 hours from the onset are 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 for patients of acute ischemic stroke who underwent endovascular thrombectomy due to large vessel occlusion of anterior circulation.
- 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 | RIC+Standard medical treatment 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 days after endovascular thrombectomy. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2018. Receives: Procedure: Remote ischemic conditioning |
| Sham RIC+Standard medical treatment | Placebo comparator | Sham RIC+Standard medical treatment 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 days after endovascular thrombectomy. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2018. 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 (12)
National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days (or discharge) after EVT.
National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days (or discharge) after EVT. Ranged from 0 to 42, a low value represents a better outcome.
Measured: 24 hours, 7 days (or discharge)
Barthel Index (BI) at 24 hours, 7 days (or discharge) after EVT.
Barthel Index (BI) at 24 hours, 7 days (or discharge) after EVT. Ranged from 0 to 100, a high value represents a better outcome.
Measured: 24 hours, 7 days (or discharge)
Proportion of patients with modified Rankin Scale (mRS) 0-1
Proportion of patients with modified Rankin Scale (mRS) 0-1. Ranged from 0 to 6, a low value represents a better outcome.
Measured: 90±3 days
modified Rankin Scale (mRS) score distribution
modified Rankin Scale (mRS) score distribution
Measured: 90±3 days
Recanalization rate within 7 days after EVT
Recanalization rate within 7 days after EVT
Measured: 7 days
Early neurological deterioration at 7 days
Early neurological deterioration at 7 days
Measured: 7 days
Frequency of Hemorrhagic transformation within 7 days
Frequency of Hemorrhagic transformation within 7 days
Measured: 7 days
Frequency of symptomatic intracranial hemorrhage within 7 days
Frequency of symptomatic intracranial hemorrhage within 7 days
Measured: 7 days
Death within 90 days
Death within 90 days
Measured: 90±3 days
Frequency of adverse events within 90 days
Frequency of adverse events within 90 days
Measured: 90±3 days
Adverse events associated with remote ischemic conditioning within 90 days
Adverse events associated with remote ischemic conditioning within 90 days
Measured: 90±3 days
Frequency of serious adverse events within 90 days
Frequency of serious adverse events within 90 days
Measured: 90±3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start26 Aug 2021
- Primary completion16 Sep 2024
- Study completion16 Sep 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 498 participants (actual)
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
- NCT04977869
- Sponsor's protocol ID
- SERIC-EVT
- Status last verified
- Dec 2024
- First submitted
- 13 Jul 2021
- Last updated
- 16 Dec 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 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Remote Ischemic Conditioning Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation: A Multicenter, Randomized, Parallel-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04977869
- Acronym / sponsor ID
- SERIC-EVT
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- Yi YangUniversity, hospital or other
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 16 Sep 2024 (actual)
- Study completion
- 16 Sep 2024 (actual)
- First posted
- 27 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 patients of acute ischemic stroke who underwent endovascular thrombectomy due to large vessel occlusion of anterior circulation.
Detailed description
In this study, 498 cases of ischemic stroke who undergo endovascular thrombectomy within 24 hours from the onset are 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 for patients of acute ischemic stroke who underwent endovascular thrombectomy due to large vessel occlusion of anterior circulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC+Standard medical treatment | Active comparator | Procedure: Remote ischemic conditioningRIC+Standard medical treatment 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 days after endovascular thrombectomy. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2018. |
| Sham RIC+Standard medical treatment | Placebo comparator | Procedure: Sham remote ischemic conditioningSham RIC+Standard medical treatment 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 days after endovascular thrombectomy. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2018. |
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, male or female
- 2) Diagnosis of acute ischemic stroke within 24 hours of symptom onset and underwent endovascular thrombectomy (EVT) adhering to current guidelines for large vessel occlusion in the anterior circulation (confirmed by computed tomography angiography or digital subtraction angiography)
- 3) Pre-EVT NIHSS ≥ 6
- 4) Premorbid mRS ≤ 2
- 5) Written informed consent obtained from the patient or legally responsible person
Key exclusion criteria (10 listed)
- 1) Contraindication of endovascular thrombectomy
- 2) Contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture, or vascular injury in the upper limb, acute or subacute venous thrombosis, arterial occlusive disease, and subclavian steal syndrome
- 3) Head CT showing cerebral hernia and midline displacement
- 4) Pregnancy or lactation
- 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.
12 secondary outcomes
National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days (or discharge) after EVT.
Time frame: 24 hours, 7 days (or discharge)
Barthel Index (BI) at 24 hours, 7 days (or discharge) after EVT.
Time frame: 24 hours, 7 days (or discharge)
Proportion of patients with modified Rankin Scale (mRS) 0-1
Time frame: 90±3 days
modified Rankin Scale (mRS) score distribution
Time frame: 90±3 days
Recanalization rate within 7 days after EVT
Time frame: 7 days
Early neurological deterioration at 7 days
Time frame: 7 days
Frequency of Hemorrhagic transformation within 7 days
Time frame: 7 days
Frequency of symptomatic intracranial hemorrhage within 7 days
Time frame: 7 days
Death within 90 days
Time frame: 90±3 days
Frequency of adverse events within 90 days
Time frame: 90±3 days
Adverse events associated with remote ischemic conditioning within 90 days
Time frame: 90±3 days
Frequency of serious adverse events within 90 days
Time frame: 90±3 days
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 16 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
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: finished, as of the sponsor's last update on 16 Dec 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?
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?
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 16 Dec 2024.