Rt-PA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke
Not Applicable
Completed
- Conditions
- Ischemic Stroke
- Interventions
- Device: Remote ischemic conditioning
- Registration Number
- NCT03231384
- Lead Sponsor
- Capital Medical University
- Brief Summary
The purpose of this study is to determine the safety and feasibility of remote limb ischemic conditioning(RIC) in acute ischemic stroke patients who received r-tPA thrombolytic therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
Inclusion Criteria
- Male or female, age≥18;
- Acute ischemic stroke;
- modified Rankin Scale (mRS) score of 2-5;
- mRS score less than 1 before onset of stroke symptom;
- Onset of stroke symptoms within 4.5h before initiation of intravenous rt-PA thrombolytic therapy;
- Good compliance for Remote Ischemic Conditioning(RIC) therapy;
- Informed consent obtained.
Exclusion Criteria
- Stroke or serious head trauma within the previous 3 months
- Major surgery or severe trauma with in the preceding 3 months
- Intracranial hemorrhage
- Systolic pressure greater than 185 mm Hg or diastolic pressure greater than 110 mm Hg, or aggressive treatment intravenous medication) necessary to reduce blood pressure to these limits
- Symptoms rapidly improving
- Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal
- Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 21 days
- Arterial puncture at a noncompressible site within the previous 7 days
- Seizure at the onset of stroke
- Platelet count of less than 100,000 per cubic millimeter
- Received heparin within the 48 hours preceding the onset of stroke and had an elevated partial-thromboplastin time
- Received oral anticoagulation therapy preceding the onset of stroke and INR greater than 1.7 or prothrombin times greater than 15 seconds
- CT showed a multiple infarction (low density area greater than 1/3 cerebral hemisphere)
- Use or plan to use intervention for diagnosis or treating
- Intracranial neoplasm, cerebral aneurysm or arteriovenous malformation
- severe hepatic or renal dysfunction
- Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.
- Life expectancy<1 years
- Pregnant or breast-feeding women
- Unwilling to be followed up or poor compliance for treatment
- Patients being enrolled or having been enrolled
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RIC group Remote ischemic conditioning The upper limb ischemic conditioning is composed of five cycles of 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.
- Primary Outcome Measures
Name Time Method Feasibility of RIC after acute ischemic stroke 7 days The proportion of enrolled subjects that completed all the designed RIC procedures.
- Secondary Outcome Measures
Name Time Method Objective signs of tissue or neurovascular injury within 7(±24h) days objective signs of tissue or neurovascular injury felt to be due to cuff inflation. Inspection included palpation of distal radial pulses, visual inspection (for local edema, redness, skin breakdown), and palpation for tenderness
Number of participants with intracranial hemorrhage in two groups 7(±24h)days Scores assessed by National Institutes of Health Stroke Scale(NIHSS) 7(±24h)days The functional outcome at 90 days assessed by modified Rankin scale (mRS). 90( ±7days) days functional outcome assessed by Barthel Index(BI) 90( ±7days)days cerebral infarct volume. 3-7 days after stroke onset The infarct volume of cerebral infarct is evaluated by cranial noncontrast CT
Cardiovascular parameters during 7 days of RIC treatment. 7 days the blood pressure were measured immediately before RIC and also be measured 5 minutes after RIC.
the heart rate during 7 days of RIC treatment. 7 days the heart rate were measured immediately before RIC and also be measured 5 minutes after RIC.
Levels of plasma myoglobin baseline and 7(±2)days Levels of serum IL-6 baseline and 7(±2)days Levels of serum HS-CRP baseline and 7(±2)days Levels of serum HCY baseline and 7(±2)days Any adverse events 90(±7)days
Trial Locations
- Locations (1)
Xuanwu Hospital, Capital Medical University
🇨🇳Beijing, XI Cheng District, China