r-tPA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke Recovery (rtPA-RIC)
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ClinicalTrials.gov Identifier: NCT02886390 |
Recruitment Status : Unknown
Verified June 2018 by Ji Xunming,MD,PhD, Capital Medical University.
Recruitment status was: Recruiting
First Posted : September 1, 2016
Last Update Posted : June 20, 2018
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Condition or disease | Intervention/treatment | Phase |
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Stroke, Acute | Device: ischemic conditioning | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Intravenous Rt-PA Thrombolysis Combined With Remote Ischemic Post-Conditioning for Acute Ischemic Stroke Patients |
Actual Study Start Date : | June 16, 2018 |
Estimated Primary Completion Date : | February 2019 |
Estimated Study Completion Date : | May 2019 |

Arm | Intervention/treatment |
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Experimental: RIC group
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.
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Device: ischemic conditioning
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.
Other Name: Doctormate, IPC-906 |
No Intervention: Control group
The participants received r-tPA thrombolytic therapy after diagnosed ischemic stroke. In addition, all participants receive a standard clinical therapy.
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- infarction volume in brain between two groups [ Time Frame: measured during 72 h ]assess by MRI-DWI and ADC
- 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 ]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
- 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 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
- 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 ]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.
- 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 ]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.
- recurrence of stroke and TIA [ Time Frame: changes from baseline(before RIPC) to 90±7 days ]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.
- death and any other adverse events [ Time Frame: changes from baseline(before RIPC) to 90±7 days ]The investigator will record the number.
- any ICH [ Time Frame: changes from baseline(before RIPC) to 90±7 days ]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.
- Distal radial pulses [ Time Frame: during 90 days ]professional doctors will check the distal radial pulses
- Visual inspection for local edema [ Time Frame: during 90 days ]Professional oculists will check the fundus oculi to evaluate whether there is local edema.
- The number of patients with erythema,and/or skin lesions related to RIC [ Time Frame: during 90 days ]Professional doctors will check it and the investigator will record the number.
- Palpation for tenderness [ Time Frame: during 90 days ]Professional doctors will check it.
- The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure [ Time Frame: during 90 days ]The investigator will record the number.
- the score of Numeric Rating Scale (NRS) [ Time Frame: during 90 days ]The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. The score from 0-10. the higher
- the score of Hamilton Rating Scale for Depression(HAMAD) [ Time Frame: change from baseline(before rtPA) to 90 days ]this score was used to provide an indication of depression, and as a guide to evaluate recovery.
- level of MMP-9 [ Time Frame: measured at baseline(before RIPC,after rtPA) and 7 days ]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
- level of IL-6 [ Time Frame: measured at baseline(before RIPC,after rtPA) and 7 days ]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
- level of HS-CRP [ Time Frame: measured at baseline(before RIPC,after rtPA) and 7 days ]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
- The level of vascular endothelial growth factor [ Time Frame: measured at baseline(before RIPC,after rtPA) and 7 days ]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

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02886390
Contact: Xunming Ji, MD. PhD | +86-10-83198952 | jixm@ccmu.edu.cn |
China, Beijing | |
Xuanwu Hospital, Capital Medical University | Recruiting |
Beijing, Beijing, China, 100053 | |
Contact: Ruiwen Che, MD rwcadl@163.com | |
Lu He hospital, Capital Medical University | Not yet recruiting |
Beijing, Beijing, China, 101149 | |
Contact: Geng, MD |
Principal Investigator: | Xunming Ji, MD. PhD | Xuanwu Hospital, Beijing |
Responsible Party: | Ji Xunming,MD,PhD, professor, Capital Medical University |
ClinicalTrials.gov Identifier: | NCT02886390 |
Other Study ID Numbers: |
RIC-2016 |
First Posted: | September 1, 2016 Key Record Dates |
Last Update Posted: | June 20, 2018 |
Last Verified: | June 2018 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
remote ischemic conditioning r-tPA thrombolytic therapy |
Stroke Ischemic Stroke Ischemia Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes |