Rt-PA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke

Capital Medical University

Status: Completed

Conditions: Ischemic Stroke

Treatments: Device: Remote ischemic conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT03231384

RIC/rtPA

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 2 patient groups

RIC group

Experimental group

Description:

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.

Treatment:

Device: Remote ischemic conditioning

Control group

No Intervention group

Description:

The participants received r-tPA thrombolytic therapy after diagnosed ischemic stroke. In addition, all participants receive a standard clinical therapy.