StrokePhase 1/2NCT01672515
Protective Effects of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction
A Phase 1/2 study testing RIPC group in people with Stroke, run by Capital Medical University.
Trial summary
Stroke is one of the three leading causes of human death, and a major cause of adult disability. Our pre-clinical studies confirmed that ischemic preconditioning can prevent cerebral infarction. Animal studies confirmed that ischemic postconditioning can reduce infarct size of cerebral infarction. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- RIPC group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Oct 2013
- Phase
- Phase 1/2
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 40 to 80 Years
- Ischemic cerebrovascular disease within 6 hours
- National Institutes of Health Stroke Scale(NIHSS) score 0-15,and Modified Rankin Scale(mRS) score 0-4
- Cranial CT to rule out the the cerebral hemorrhage
- Written informed consent was
Who cannot join
- Cerebral hemorrhage
- Other parts of the active bleeding disease
- Atrial fibrillation
- Moyamoya disease or vasculitis
- Hereditary disease, such as with CADASIL, FABRY, mitochondrial myopathy
- Out coagulation disorder
- Severe lesions of severe liver and kidney disease, malignancy or other systemic
- Cannot tolerate BLIPC or without informed consent
About this study
Official title: Phase 2 Study of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction
Stroke is one of the three leading causes of human death, and a major cause of adult disability. Our pre-clinical studies confirmed that ischemic preconditioning can prevent cerebral infarction. Animal studies confirmed that ischemic postconditioning can reduce infarct size of cerebral infarction. Investigators hypothesized that postconditioning would reduce infarct volume of ischemic stroke patients.
Read the detailed description
This study explored the neuroprotective effects of post-positioning on ischemic stroke patients with randomized, double-blinded and controlled method. Patients are divided into experimental and placebo groups to receive remote ischemic post-conditioning for 30 days. Remote ischemic post-conditioning is performed by the inflating tourniquets to certain extents on bilateral arms with 5 cycles of 5min inflation and 5min relax alternation for the total of 30 consecutive days. It is 200mmHg for RIPC group and 60mmHg for control group. Evaluation parameters include CRP, TNF-α, ICAM-1 and GFAP in blood at 0, 3, 7, 15 and 30 days after treatment; and MRI at 0 and 30 days after treatment.
- Conditions
- Stroke
- Being tested
- RIPC group, Control group
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIPC groupDevice
Also called Brand name: Doctormate, Type: IPC-906X, Productor: Beijing Renqiao Institute of Neuroscience
Control groupDevice
Also called Brand name: Doctormate, Type: modified version of IPC-906X, Productor: Beijing Renqiao Institute of Neuroscience
| Study group | Role | What they receive |
|---|---|---|
| RIPC group | Experimental | RIPC treatment was performed by the inflating tourniquets to 200mmHg on bilateral arms with 5 cycles of 5min inflation and 5min relax alternation for the total of 30 consecutive days. Receives: Device: RIPC group |
| Control group | Sham comparator | RIPC sham was performed by the inflating tourniquets to 60mmHg on bilateral arms with 5 cycles of 5min inflation and 5min relax alternation for the total of 30 consecutive days. Receives: Device: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tissue damage 30 days after RIPC treatment
Evaluated by the doctor blinded to the study protocol, including: local edema, redness, skin breakage
Measured: 30 days after RIPC treatment
Levels of plasma biomarkers assay right before RIPC treatment
levels of CRP、TINF-α、slCAM-1 and GFAP
Measured: right before RIPC treatment (within 24hrs)
Levels of plasma biomarkers assay 3 days after RIPC treatment.
levels of CRP、TINF-α、slCAM-1 and GFAP
Measured: 3 days after RIPC treatment.
Levels of plasma biomarkers assay 15 days after RIPC treatment.
levels of CRP、TINF-α、slCAM-1 and GFAP
Measured: 15 days after RIPC treatment.
Levels of plasma biomarkers assay 30 days after RIPC treatment
levels of CRP、TINF-α、slCAM-1 and GFAP
Measured: 30 days after RIPC treatment
Levels of plasma biomarkers assay right after RIPC treatment
levels of CRP、TINF-α、slCAM-1 and GFAP
Measured: right after RIPC treatment (within 24hrs)
Secondary outcomes (2)
Infarct volume evaluation before RIPC treatment.
MRI evaluation of infarct volume in ischemic stroke patients before RIPC treatment.
Measured: Acute phase of ischemic stroke, and before RIPC treatment
Infarct volume after RIPC treatment in ischemic stroke patients
Infarct volume evaluation in ischemic stroke patients after 30 RIPC treatment
Measured: 30 days after RIPC treatment in ischemic stroke patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2013 (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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672515
- Sponsor's protocol ID
- 2012-RIPC-cerebral infarction
- Status last verified
- Aug 2012
- First submitted
- 19 Aug 2012
- Last updated
- 27 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction
- ClinicalTrials.gov ID
- NCT01672515
- Acronym / sponsor ID
- 2012-RIPC-cerebral infarction
- Conditions
- Stroke
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (estimated)
- First posted
- 27 Aug 2012 (estimated)
- 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.
Stroke is one of the three leading causes of human death, and a major cause of adult disability. Our pre-clinical studies confirmed that ischemic preconditioning can prevent cerebral infarction. Animal studies confirmed that ischemic postconditioning can reduce infarct size of cerebral infarction. Investigators hypothesized that postconditioning would reduce infarct volume of ischemic stroke patients.
Detailed description
This study explored the neuroprotective effects of post-positioning on ischemic stroke patients with randomized, double-blinded and controlled method. Patients are divided into experimental and placebo groups to receive remote ischemic post-conditioning for 30 days. Remote ischemic post-conditioning is performed by the inflating tourniquets to certain extents on bilateral arms with 5 cycles of 5min inflation and 5min relax alternation for the total of 30 consecutive days. It is 200mmHg for RIPC group and 60mmHg for control group. Evaluation parameters include CRP, TNF-α, ICAM-1 and GFAP in blood at 0, 3, 7, 15 and 30 days after treatment; and MRI at 0 and 30 days after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIPC group | Experimental | Device: RIPC groupRIPC treatment was performed by the inflating tourniquets to 200mmHg on bilateral arms with 5 cycles of 5min inflation and 5min relax alternation for the total of 30 consecutive days. |
| Control group | Sham comparator | Device: Control groupRIPC sham was performed by the inflating tourniquets to 60mmHg on bilateral arms with 5 cycles of 5min inflation and 5min relax alternation for the total of 30 consecutive days. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age between 40 to 80 Years
- Ischemic cerebrovascular disease within 6 hours
- National Institutes of Health Stroke Scale(NIHSS) score 0-15,and Modified Rankin Scale(mRS) score 0-4
- Cranial CT to rule out the the cerebral hemorrhage
- Written informed consent was
Key exclusion criteria (8 listed)
- Cerebral hemorrhage
- Other parts of the active bleeding disease
- Atrial fibrillation
- Moyamoya disease or vasculitis
- Hereditary disease, such as with CADASIL, FABRY, mitochondrial myopathy
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 |
|---|---|---|
| RIPC groupAlso: Brand name: Doctormate, Type: IPC-906X, Productor: Beijing Renqiao Institute of Neuroscience | Device | RIPC group |
| Control groupAlso: Brand name: Doctormate, Type: modified version of IPC-906X, Productor: Beijing Renqiao Institute of Neuroscience | Device | Control group |
Primary outcome
Local tissue damage 30 days after RIPC treatment
Time frame: 30 days after RIPC treatment
Evaluated by the doctor blinded to the study protocol, including: local edema, redness, skin breakage
Levels of plasma biomarkers assay right before RIPC treatment
Time frame: right before RIPC treatment (within 24hrs)
levels of CRP、TINF-α、slCAM-1 and GFAP
Levels of plasma biomarkers assay 3 days after RIPC treatment.
Time frame: 3 days after RIPC treatment.
levels of CRP、TINF-α、slCAM-1 and GFAP
Levels of plasma biomarkers assay 15 days after RIPC treatment.
Time frame: 15 days after RIPC treatment.
levels of CRP、TINF-α、slCAM-1 and GFAP
Levels of plasma biomarkers assay 30 days after RIPC treatment
Time frame: 30 days after RIPC treatment
levels of CRP、TINF-α、slCAM-1 and GFAP
Levels of plasma biomarkers assay right after RIPC treatment
Time frame: right after RIPC treatment (within 24hrs)
levels of CRP、TINF-α、slCAM-1 and GFAP
2 secondary outcomes
Infarct volume evaluation before RIPC treatment.
Time frame: Acute phase of ischemic stroke, and before RIPC treatment
Infarct volume after RIPC treatment in ischemic stroke patients
Time frame: 30 days after RIPC treatment in ischemic stroke patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2012.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RIPC group in people with Stroke, run by Capital 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 8 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 27 Aug 2012. 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. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Local tissue damage 30 days after RIPC treatment (time frame: 30 days after RIPC treatment). The study lists 6 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 27 Aug 2012.