Clinical trial NCT03231384: Rt-PA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke
Official title: Safety and Feasibility of Rt-PA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke(rtPA-RIC1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2017-07-27
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Feasibility of RIC after acute ischemic stroke
timeFrame: 7 days
Secondary outcomes:
measure: Objective signs of tissue or neurovascular injury
timeFrame: within 7(±24h) days
measure: Number of participants with intracranial hemorrhage in two groups
timeFrame: 7(±24h)days
measure: Scores assessed by National Institutes of Health Stroke Scale(NIHSS)
timeFrame: 7(±24h)days
measure: The functional outcome at 90 days assessed by modified Rankin scale (mRS).
timeFrame: 90( ±7days) days
measure: functional outcome assessed by Barthel Index(BI)
timeFrame: 90( ±7days)days
measure: cerebral infarct volume.
timeFrame: 3-7 days after stroke onset
measure: cerebral infarct volume.
timeFrame: 3-7 days after stroke onset
measure: Cardiovascular parameters during 7 days of RIC treatment.
timeFrame: 7 days
measure: the heart rate during 7 days of RIC treatment.
timeFrame: 7 days
measure: Levels of plasma myoglobin
timeFrame: baseline and 7(±2)days
measure: Levels of serum IL-6
timeFrame: baseline and 7(±2)days
measure: Levels of serum HS-CRP
timeFrame: baseline and 7(±2)days
measure: Levels of serum HCY
timeFrame: baseline and 7(±2)days
measure: Any adverse events
timeFrame: 90(±7)days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: XI Cheng District
Study officials:
References: