Acute Ischemic StrokeRIC-SIIDNCT04069546
The Efficacy of Remote Ischemic Conditioning on Stroke-induced Immunodeficiency
A study testing remote ischemic conditioning in people with Acute Ischemic Stroke, run by Capital Medical University at 1 site in China.
Trial summary
to detect the effects of RIC on stroke-induced immunodeficiency and inflammation response in acute ischemic stroke patients 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
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2019to 1 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18 years old;
- Confirmed diagnosis of acute ischemic stroke(AIS) with onset of symptoms within 48h at recruitment;
- NIHSS score: ≤15;
- Prestroke modified Rankin Scale(mRS) ≤2;
- subject or his or her legally authorized representative was able to provide informed consent.
Who cannot join
- uncontrolled hypertension (defined as systolic blood pressure ≥200 mmHg);
- participation in another device or drug trial simultaneously;
- any vascular, soft tissue, or orthopedic injury (eg, superficial wounds and fractures of the arm) that contraindicated unilateral arm ischemic preconditioning;
- peripheral vascular disease (especially subclavian arterial and upper limb artery stenosis or occlusion);
- Women who have a positive pregnancy test;
- History of malignancies;
Show all 10Show fewer
- Using remote ischemic conditioning within the preceding 1 week;
- known infection at admission;
- a history of infection or the use of antibiotics, immunosuppressants, or steroids within the preceding 3 months.
- Other conditions are not suitable for this trial (evaluated by researchers)
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital, Capital Medical University
Beijing, XI Cheng District,, 100053
About this study
to detect the effects of RIC on stroke-induced immunodeficiency and inflammation response in acute ischemic stroke patients
Read the detailed description
Remote ischemic conditioning, consisting of several brief cycles of intermittent ischemia-reperfusion of the arm or leg, may potentially confer systemic protection against prolonged ischemia in a distant organ. Numerous reports have confirmed its strongest endogenous neuroprotection against brain injury after stroke, of which the immune mechanisms are majorly involved in RIC. At the same time, the inflammation response plays a great role in stroke development, which may expand the infarct area. Stroke-induced immunodeficiency can potentiate stroke-associated pneumonia, which is an important cause of death after strokes. In this study, the investigators will assess the effect of RIC on stroke-induced immunodeficiency and inflammation response in AIS patients.
- Conditions
- Acute Ischemic Stroke
- Being tested
- remote ischemic conditioning
- Keywords
- Acute Ischemic Stroke, Remote ischemic preconditioning, Stroke-induced immunodeficiency, Stroke-associated Pneumonia, inflammation response
- 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
RIC is a physical strategy performed by an electric device with cuffs placed on the unilateral arm and inflated to 180 mmHg for 5-min followed by deflation for 5-min, the procedures are performed repeatedly for 5 times.
| Study group | Role | What they receive |
|---|---|---|
| AIS-RIC | Experimental | RIC is a physical strategy performed through cuffs placed on the unilateral arm and inflated to 180 mmHg for 5-min followed by deflation for 5-min, the procedures are performed repeatedly for 5 times. This group of patients received regular therapy of acute ischemic stroke plus unilateral arm of RIC intervention. Receives: Device: remote ischemic conditioning |
| AIS | No intervention | This group of patients received regular therapy of acute ischemic stroke. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of mHLA-DR level in plasma
through flow cytometry
Measured: change from baseline to 2(±24h)days, and at 7(±24h)days after admission
Secondary outcomes (7)
The changes of TLR-2, TLR-4 level in plasma
through flow cytometry
Measured: change from baseline to 2(±24h)days, and at 7(±24h)days after admission
Incidence of Stroke-associated Pneumonia within 1 week
Stroke-associated Pneumonia diagnostic criteria base on the consensus of 2015
Stroke-associated Pneumonia diagnostic criteria base on the consensus of 2015
Stroke-associated Pneumonia diagnostic criteria base on the consensus of 2015
Measured: within 7(±24h)days after admission
Number of Participants with physician-diagnosed pneumonia within 90 days after stroke onset
Number of Participants with Physician-diagnosed Pneumonia within 90 days after stroke onset Physician-diagnosed Pneumonia within 90 days
Measured: 90( ±7days) days after ischemic stroke onset
White blood cell count, monocyte count
through routine blood test
Measured: baseline, 2(±24h) days, 7(±24h) days after admission
Concentration of IL-1β、IL-6、IL-10、TNFα（CRP if patients are infected）level
inflammatory cytokines
Measured: baseline, 2(±24h)days, and at 7(±24h)days after admission
Number of Participants with Favorable outcome at 90 days
definition of favorable outcome: mRS : 0-2 or NIHSS: 0-1
Measured: 90 days after ischemic stroke onset
Number of Participants with any adverse events
adverse events include stroke extension, gastrointestinal bleed, cardiac events, increased liver or renal enzymes, and transfer to intensive care unit.
Measured: during baseline to 90 days after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start7 Sep 2019
- Primary completion1 Feb 2020
- Study completion1 Feb 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.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069546
- Sponsor's protocol ID
- RIC-SIID
- Acronym
- RIC-SIID
- Status last verified
- Dec 2020
- First submitted
- 23 Aug 2019
- Last updated
- 28 Dec 2020
- 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 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Remote Ischemic Conditioning on Stroke-induced Immunodeficiency
- ClinicalTrials.gov ID
- NCT04069546
- Acronym / sponsor ID
- RIC-SIID / RIC-SIID
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Remote ischemic preconditioning, Stroke-induced immunodeficiency, Stroke-associated Pneumonia, inflammation response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 7 Sep 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 28 Aug 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.
to detect the effects of RIC on stroke-induced immunodeficiency and inflammation response in acute ischemic stroke patients
Detailed description
Remote ischemic conditioning, consisting of several brief cycles of intermittent ischemia-reperfusion of the arm or leg, may potentially confer systemic protection against prolonged ischemia in a distant organ. Numerous reports have confirmed its strongest endogenous neuroprotection against brain injury after stroke, of which the immune mechanisms are majorly involved in RIC. At the same time, the inflammation response plays a great role in stroke development, which may expand the infarct area. Stroke-induced immunodeficiency can potentiate stroke-associated pneumonia, which is an important cause of death after strokes. In this study, the investigators will assess the effect of RIC on stroke-induced immunodeficiency and inflammation response in AIS patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIS-RIC | Experimental | Device: remote ischemic conditioningRIC is a physical strategy performed through cuffs placed on the unilateral arm and inflated to 180 mmHg for 5-min followed by deflation for 5-min, the procedures are performed repeatedly for 5 times. This group of patients received regular therapy of acute ischemic stroke plus unilateral arm of RIC intervention. |
| AIS | No intervention | –This group of patients received regular therapy of acute ischemic stroke. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age≥18 years old;
- Confirmed diagnosis of acute ischemic stroke(AIS) with onset of symptoms within 48h at recruitment;
- NIHSS score: ≤15;
- Prestroke modified Rankin Scale(mRS) ≤2;
- subject or his or her legally authorized representative was able to provide informed consent.
Key exclusion criteria (10 listed)
- uncontrolled hypertension (defined as systolic blood pressure ≥200 mmHg);
- participation in another device or drug trial simultaneously;
- any vascular, soft tissue, or orthopedic injury (eg, superficial wounds and fractures of the arm) that contraindicated unilateral arm ischemic preconditioning;
- peripheral vascular disease (especially subclavian arterial and upper limb artery stenosis or occlusion);
- Women who have a positive pregnancy test;
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 conditioningRIC is a physical strategy performed by an electric device with cuffs placed on the unilateral arm and inflated to 180 mmHg for 5-min followed by deflation for 5-min, the procedures are performed repeatedly for 5 times. | Device | AIS-RIC |
Primary outcome
The changes of mHLA-DR level in plasma
Time frame: change from baseline to 2(±24h)days, and at 7(±24h)days after admission
through flow cytometry
7 secondary outcomes
The changes of TLR-2, TLR-4 level in plasma
Time frame: change from baseline to 2(±24h)days, and at 7(±24h)days after admission
Incidence of Stroke-associated Pneumonia within 1 week
Time frame: within 7(±24h)days after admission
Number of Participants with physician-diagnosed pneumonia within 90 days after stroke onset
Time frame: 90( ±7days) days after ischemic stroke onset
White blood cell count, monocyte count
Time frame: baseline, 2(±24h) days, 7(±24h) days after admission
Concentration of IL-1β、IL-6、IL-10、TNFα（CRP if patients are infected）level
Time frame: baseline, 2(±24h)days, and at 7(±24h)days after admission
Number of Participants with Favorable outcome at 90 days
Time frame: 90 days after ischemic stroke onset
Number of Participants with any adverse events
Time frame: during baseline to 90 days after stroke onset
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 28 Dec 2020.
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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 Capital Medical University 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 28 Dec 2020. 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. 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?
The changes of mHLA-DR level in plasma (time frame: change from baseline to 2(±24h)days, and at 7(±24h)days after admission). 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 28 Dec 2020.