Stroke, AcutertPA-RICNCT02886390
r-tPA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke Recovery
A study testing ischemic conditioning in people with Stroke, Acute, run by Capital Medical University at 2 sites in China.
Trial summary
to detect the efficiency and safety of intravenous rtPA combined with RIPC in acute ischemic stroke patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- ischemic conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 16 Jun 2018to May 2019
- 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
- Male or female, age≥18;
- Clinical sign and symptoms consistent with the diagnosis of an acute ischemic stroke, onset of stroke symptoms within 4.5 h before initiation of intravenous rt-PA thrombolytic therapy;
- Baseline National Institutes of Health Stroke Scale (NIHSS) score of 4-15 (assessed before intravenous alteplase), mRS ≤1 before onset of stroke symptom;
- No contraindication for MRI.
- Informed consent obtained
Who cannot join
- Cardioembolism；
- Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs;
- Life expectancy < 1 year;
- Pregnant or breast-feeding women;
- Unwilling to be followed up or poor compliance for treatment; (5) Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Ruiwen Che, MD, rwcadl@163.com
- Not yet recruiting
Lu He hospital, Capital Medical University
Beijing, Beijing Municipality, 101149
Geng, MD
About this study
Official title: Intravenous Rt-PA Thrombolysis Combined With Remote Ischemic Post-Conditioning for Acute Ischemic Stroke Patients
to detect the efficiency and safety of intravenous rtPA combined with RIPC in acute ischemic stroke patients
Read the detailed description
Remote ischemic post-conditioning, which consists of several brief cycles of intermittent ischemia-reperfusion of the arm or leg, may potentially confer a powerful systemic protection against prolonged ischemia in a distant organ. Numerous reports have confirmed it strongest endogenous neuroprotection against brain injury after stroke. Ren et al demonstrated that remote ischemic post-conditioning (RIPC) performed in the hind limbs can not only significantly reduce the stroke volume within 3 hours in rat model, but also ameliorate the outcome of the behavioral test. A long-term repeated RIPC therapy can also help improving neurological functions. A combination of RIPC and tPA can help with neuroprotection which improves the neurological functions. Thus, it is meaningful to transform these basic experimental results to the clinical treatment. In the RECAST-1 trial, RIC has shown it safety and efficiency in AIS patients without tPA. However, there is no further explanation for the patients with IVT. Thus, in this study, we aim to demonstrate the efficiency and safety of RIPC in AIS patients performed rt-PA within 4.5 hours.
- Conditions
- Stroke, Acute
- Being tested
- ischemic conditioning
- Keywords
- remote ischemic conditioning, r-tPA thrombolytic therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ischemic conditioningDevice
Also called Doctormate, IPC-906
In this study, the remote ischemic conditioning treatment was composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which was induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation.
| Study group | Role | What they receive |
|---|---|---|
| RIC group | Experimental | The upper limb ischemic conditioning is composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which is induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. This therapy started within 2 hours after r-tPA thrombolytic therapy. In addition, all participants receive a standard clinical therapy. Receives: Device: ischemic conditioning |
| Control group | No intervention | The participants received r-tPA thrombolytic therapy after diagnosed ischemic stroke. In addition, all participants receive a standard clinical therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
infarction volume in brain between two groups
assess by MRI-DWI and ADC
Measured: measured during 72 h
Secondary outcomes (18)
The score of Modified Rankin scale score
The Modified Rankin Scale Score (mRS) is the most comprehensive and most widely used primary outcome measurement to assess the neurological functional disability in contemporary acute stroke trials. The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranges from 0 (no symptom) to 5 (severe disability) and 6 (death). We will use mRS to evaluate the degree of disability or dependence during daily activities. The mRS will be assessed by certified study investigator, who is blinded to the treatment assignment, at 90 days postoperation. The distribution of mRS will be compared between groups
Measured: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
proportional of Modified Rankin scale scored 0-1
The Modified Rankin Scale Score (mRS) is the most comprehensive and most widely used primary outcome measurement to assess the neurological functional disability in contemporary acute stroke trials. The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranges from 0 (no symptom) to 5 (severe disability) and 6 (death). We will use mRS to evaluate the degree of disability or dependence during daily activities. The mRS will be assessed by certified study investigator, who is blinded to the treatment assignment, at 90 days postoperation. The distribution of mRS will be compared between groups
Measured: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
The score of National Institute of Health stroke scale score
National Institute of Health Stroke Scale (NIHSS) is considered as a standardized assessment of neurological functions in the acute phase of stroke, and it is generally used to quantify patient's neurological impairments on 15 items in 11 fields of different neurological status.The score of the scale ranges from 0 to 42.And higher score indicates worse neurological function.
Measured: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
The score of Barthel Index(BI)
the BI is used to measure performance in activities of daily living.The score of the scale ranges from 0 to 100. And lower score indicates worse activities of daily living.
Measured: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
recurrence of stroke and TIA
Stroke recurrence was defined as sudden functional deterioration in neurologic status with a decrease of 4 or more in the NIHSS, or a new stroke lesion on MRI/DWI located at the territory of the affected intracranial arteries.
Measured: changes from baseline(before RIPC) to 90±7 days
death and any other adverse events
The investigator will record the number.
Measured: changes from baseline(before RIPC) to 90±7 days
any ICH
Head computed tomography or magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.
Measured: changes from baseline(before RIPC) to 90±7 days
Distal radial pulses
professional doctors will check the distal radial pulses
Measured: during 90 days
Visual inspection for local edema
Professional oculists will check the fundus oculi to evaluate whether there is local edema.
Measured: during 90 days
The number of patients with erythema,and/or skin lesions related to RIC
Professional doctors will check it and the investigator will record the number.
Measured: during 90 days
Palpation for tenderness
Professional doctors will check it.
Measured: during 90 days
The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure
The investigator will record the number.
Measured: during 90 days
the score of Numeric Rating Scale (NRS)
The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. The score from 0-10. the higher
Measured: during 90 days
the score of Hamilton Rating Scale for Depression（HAMAD）
this score was used to provide an indication of depression, and as a guide to evaluate recovery.
Measured: change from baseline(before rtPA) to 90 days
level of MMP-9
Blood samples will be drawn from cubital vein to test these biomarkers.These samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
Measured: measured at baseline(before RIPC,after rtPA) and 7 days
level of IL-6
Blood samples will be drawn from cubital vein to test these biomarkers.These samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
Measured: measured at baseline(before RIPC,after rtPA) and 7 days
level of HS-CRP
Blood samples will be drawn from cubital vein to test these biomarkers.These samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
Measured: measured at baseline(before RIPC,after rtPA) and 7 days
The level of vascular endothelial growth factor
Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
Measured: measured at baseline(before RIPC,after rtPA) and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study start16 Jun 2018
- Primary completionFeb 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
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
- Investigators
- Xunming Ji, MD. PhD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886390
- Sponsor's protocol ID
- RIC-2016
- Acronym
- rtPA-RIC
- Status last verified
- Jun 2018
- First submitted
- 28 Aug 2016
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Rt-PA Thrombolysis Combined With Remote Ischemic Post-Conditioning for Acute Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT02886390
- Acronym / sponsor ID
- rtPA-RIC / RIC-2016
- Conditions
- Stroke, Acute
- Keywords
- remote ischemic conditioning, r-tPA thrombolytic therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 16 Jun 2018 (actual)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 1 Sep 2016 (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.
to detect the efficiency and safety of intravenous rtPA combined with RIPC in acute ischemic stroke patients
Detailed description
Remote ischemic post-conditioning, which consists of several brief cycles of intermittent ischemia-reperfusion of the arm or leg, may potentially confer a powerful systemic protection against prolonged ischemia in a distant organ. Numerous reports have confirmed it strongest endogenous neuroprotection against brain injury after stroke. Ren et al demonstrated that remote ischemic post-conditioning (RIPC) performed in the hind limbs can not only significantly reduce the stroke volume within 3 hours in rat model, but also ameliorate the outcome of the behavioral test. A long-term repeated RIPC therapy can also help improving neurological functions. A combination of RIPC and tPA can help with neuroprotection which improves the neurological functions. Thus, it is meaningful to transform these basic experimental results to the clinical treatment. In the RECAST-1 trial, RIC has shown it safety and efficiency in AIS patients without tPA. However, there is no further explanation for the patients with IVT. Thus, in this study, we aim to demonstrate the efficiency and safety of RIPC in AIS patients performed rt-PA within 4.5 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC group | Experimental | Device: ischemic conditioningThe upper limb ischemic conditioning is composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which is induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. This therapy started within 2 hours after r-tPA thrombolytic therapy. In addition, all participants receive a standard clinical therapy. |
| Control group | No intervention | –The participants received r-tPA thrombolytic therapy after diagnosed ischemic stroke. In addition, all participants receive a standard clinical therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, age≥18;
- Clinical sign and symptoms consistent with the diagnosis of an acute ischemic stroke, onset of stroke symptoms within 4.5 h before initiation of intravenous rt-PA thrombolytic therapy;
- Baseline National Institutes of Health Stroke Scale (NIHSS) score of 4-15 (assessed before intravenous alteplase), mRS ≤1 before onset of stroke symptom;
- No contraindication for MRI.
- Informed consent obtained
Key exclusion criteria (5 listed)
- Cardioembolism；
- Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs;
- Life expectancy < 1 year;
- Pregnant or breast-feeding women;
- Unwilling to be followed up or poor compliance for treatment; (5) Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.
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 |
|---|---|---|
| ischemic conditioningAlso: Doctormate, IPC-906In this study, the remote ischemic conditioning treatment was composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which was induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. | Device | RIC group |
Primary outcome
infarction volume in brain between two groups
Time frame: measured during 72 h
assess by MRI-DWI and ADC
18 secondary outcomes
The score of Modified Rankin scale score
Time frame: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
proportional of Modified Rankin scale scored 0-1
Time frame: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
The score of National Institute of Health stroke scale score
Time frame: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
The score of Barthel Index(BI)
Time frame: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
recurrence of stroke and TIA
Time frame: changes from baseline(before RIPC) to 90±7 days
death and any other adverse events
Time frame: changes from baseline(before RIPC) to 90±7 days
any ICH
Time frame: changes from baseline(before RIPC) to 90±7 days
Distal radial pulses
Time frame: during 90 days
Visual inspection for local edema
Time frame: during 90 days
The number of patients with erythema,and/or skin lesions related to RIC
Time frame: during 90 days
Palpation for tenderness
Time frame: during 90 days
The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure
Time frame: during 90 days
the score of Numeric Rating Scale (NRS)
Time frame: during 90 days
the score of Hamilton Rating Scale for Depression（HAMAD）
Time frame: change from baseline(before rtPA) to 90 days
level of MMP-9
Time frame: measured at baseline(before RIPC,after rtPA) and 7 days
level of IL-6
Time frame: measured at baseline(before RIPC,after rtPA) and 7 days
level of HS-CRP
Time frame: measured at baseline(before RIPC,after rtPA) and 7 days
The level of vascular endothelial growth factor
Time frame: measured at baseline(before RIPC,after rtPA) and 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
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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.
Xunming Ji, MD. PhD principal investigator
Xuanwu Hospital, Beijing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ischemic conditioning in people with Stroke, Acute, run by Capital Medical University at 2 sites 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 5 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 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xunming Ji, MD. PhD (+86-10-83198952, jixm@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infarction volume in brain between two groups (time frame: measured during 72 h). 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 20 Jun 2018; AzTrials last refreshed its copy on 6 Nov 2026.