Clinical trial NCT02886390: r-tPA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke Recovery
Official title: Intravenous Rt-PA Thrombolysis Combined With Remote Ischemic Post-Conditioning for Acute Ischemic Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Acute
Keywords: remote ischemic conditioning
r-tPA thrombolytic therapy
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: infarction volume in brain between two groups
timeFrame: measured during 72 h
Secondary outcomes:
measure: The score of Modified Rankin scale score
timeFrame: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
measure: proportional of Modified Rankin scale scored 0-1
timeFrame: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
measure: The score of National Institute of Health stroke scale score
timeFrame: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
measure: The score of Barthel Index(BI)
timeFrame: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
measure: recurrence of stroke and TIA
timeFrame: changes from baseline(before RIPC) to 90±7 days
measure: death and any other adverse events
timeFrame: changes from baseline(before RIPC) to 90±7 days
measure: any ICH
timeFrame: changes from baseline(before RIPC) to 90±7 days
measure: Distal radial pulses
timeFrame: during 90 days
measure: Visual inspection for local edema
timeFrame: during 90 days
measure: The number of patients with erythema,and/or skin lesions related to RIC
timeFrame: during 90 days
measure: Palpation for tenderness
timeFrame: during 90 days
measure: The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure
timeFrame: during 90 days
measure: the score of Numeric Rating Scale (NRS)
timeFrame: during 90 days
measure: the score of Hamilton Rating Scale for Depression（HAMAD）
timeFrame: change from baseline(before rtPA) to 90 days
measure: level of MMP-9
timeFrame: measured at baseline(before RIPC,after rtPA) and 7 days
measure: level of IL-6
timeFrame: measured at baseline(before RIPC,after rtPA) and 7 days
measure: level of HS-CRP
timeFrame: measured at baseline(before RIPC,after rtPA) and 7 days
measure: The level of vascular endothelial growth factor
timeFrame: measured at baseline(before RIPC,after rtPA) and 7 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Lu He hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Xunming Ji, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References: