Status:
COMPLETED
Rt-PA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke
Lead Sponsor:
Capital Medical University
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2018
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03231384
Start Date
August 10 2017
End Date
February 14 2018
Last Update
March 27 2018
Active Locations (1)
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1
Xuanwu Hospital, Capital Medical University
Beijing, XI Cheng District, China, 100053