Acute Ischemic StrokeSERICT-AISNCT04027621
Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating 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 combined with intravenous thrombolysis in treating acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- remote ischemic conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 20 Jul 2020
- 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
- 1) Age≥18 years, < 80 years, regardless of sex;
- 2) Patients with clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis;
- 3) Baseline NIHSS >= 5, and <= 25;
- 4) Baseline GCS ≥8;
- 5) Signed and dated informed consent is obtained
Who cannot join
- 1) Patients who undergo endovascular treatment;
- 2) mRS ≥ 2 before the onset of the disease;
- 3) Double upper limbs or lower limbs paralysis was found in this case;
- 4) Active bleeding of organs within 6 months of admission or current, including cerebral hemorrhage, subarachnoid hemorrhage, gastrointestinal hemorrhage, fundus hemorrhage and so on;
- 5) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumor and other diseases involving the brain;
- 6) Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban;
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- 7) Severe organ dysfunction or failure;
- 8) Patients suffering from severe hematological diseases or severe coagulation disorder dysfunction
- 9) Those who have a history of severe trauma or had major surgery within 6 months prior to admission;
- 10) Those who have a history of atrial fibrillation;
- 11) The patients who have 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;
- 12) Pregnant or lactating women;
- 13) Previous remote ischemic conditioning therapy or similar treatment;
- 14) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons;
- 15) Severe hepatic and renal dysfunction;
- 16) Unwilling to be followed up or treated for poor compliance;
- 17) 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;
- 18) Other conditions that the researchers think are not suitable for the group.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis in treating acute ischemic stroke.
Read the detailed description
In this study, cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times within 6 hours to 24 hours from thrombolysis. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times within 6 hours to 24 hours from thrombolysis . Two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis 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 conditioningDevice
Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg.
sham remote ischemic conditioningDevice
Sham remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg.
| Study group | Role | What they receive |
|---|---|---|
| RIC group | 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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice within 6 to 24 hours from thrombolysis. Additionally,the patients will be treated with standard medical treatment according to Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014. Receives: Device: remote ischemic conditioning |
| control group | 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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice twice within 6 to 24 hours from thrombolysis. Additionally,the patients will be treated with standard medical treatment according to Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014 Receives: Device: sham remote ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events during hospitalization
All adverse events until day-7 or discharge (whichever is earlier)
Measured: 7 days
Frequency of adverse events during follow-up
Severe adverse events through day-90 after the onset of acute ischemic stroke.
Measured: 3 months
Secondary outcomes (2)
National Institute of Health stroke scale (NIHSS) at 7 days from onset or discharge
National Institute of Health stroke scale (NIHSS) at 7 days from onset or discharge. Ranged from 0 to 42, a low value represents a better outcome.
Measured: 7 days
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start1 Jul 2019
- Primary completion1 Jul 2020
- Study completion20 Jul 2020
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
- 50 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
- NCT04027621
- Sponsor's protocol ID
- SERICT-AIS
- Acronym
- SERICT-AIS
- Status last verified
- Jun 2022
- First submitted
- 14 Jul 2019
- Last updated
- 30 Jun 2022
- 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 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04027621
- Acronym / sponsor ID
- SERICT-AIS / SERICT-AIS
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yi YangUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 22 Jul 2019 (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 combined with intravenous thrombolysis in treating acute ischemic stroke.
Detailed description
In this study, cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times within 6 hours to 24 hours from thrombolysis. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times within 6 hours to 24 hours from thrombolysis . Two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis 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 group | Active comparator | Device: 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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice within 6 to 24 hours from thrombolysis. Additionally,the patients will be treated with standard medical treatment according to Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014. |
| control group | Placebo comparator | Device: 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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice twice within 6 to 24 hours from thrombolysis. Additionally,the patients will be treated with standard medical treatment according to Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1) Age≥18 years, < 80 years, regardless of sex;
- 2) Patients with clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis;
- 3) Baseline NIHSS >= 5, and <= 25;
- 4) Baseline GCS ≥8;
- 5) Signed and dated informed consent is obtained
Key exclusion criteria (18 listed)
- 1) Patients who undergo endovascular treatment;
- 2) mRS ≥ 2 before the onset of the disease;
- 3) Double upper limbs or lower limbs paralysis was found in this case;
- 4) Active bleeding of organs within 6 months of admission or current, including cerebral hemorrhage, subarachnoid hemorrhage, gastrointestinal hemorrhage, fundus hemorrhage and so on;
- 5) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumor and other diseases involving the brain;
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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. | Device | RIC group |
| 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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. | Device | control group |
Primary outcome
Frequency of adverse events during hospitalization
Time frame: 7 days
All adverse events until day-7 or discharge (whichever is earlier)
Frequency of adverse events during follow-up
Time frame: 3 months
Severe adverse events through day-90 after the onset of acute ischemic stroke.
2 secondary outcomes
National Institute of Health stroke scale (NIHSS) at 7 days from onset or discharge
Time frame: 7 days
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2
Time frame: 3 months
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 Jun 2022.
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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 18 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 Jun 2022. 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?
Frequency of adverse events during hospitalization (time frame: 7 days). The study lists 2 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 Jun 2022.