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

Safety and Feasibility of Rt-PA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke(rtPA-RIC1)

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke
• Intervention / Treatment: Device: Remote ischemic conditioning

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • XI Cheng District
    • Beijing, XI Cheng District, China, 100053
      • Xuanwu Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; The participants received r-tPA thrombolytic therapy after diagnosed ischemic stroke. In addition, all participants receive a standard clinical therapy.
Experimental: RIC group; 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.	Device: Remote ischemic conditioning; In this study, the remote ischemic conditioning treatment was composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which was 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. Doctormate, IPC-906

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of RIC after acute ischemic stroke	The proportion of enrolled subjects that completed all the designed RIC procedures.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective signs of tissue or neurovascular injury	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	within 7(±24h) days
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.	The infarct volume of cerebral infarct is evaluated by cranial noncontrast MRI	3-7 days after stroke onset
cerebral infarct volume.	The infarct volume of cerebral infarct is evaluated by cranial noncontrast CT	3-7 days after stroke onset
Cardiovascular parameters during 7 days of RIC treatment.	the blood pressure were measured immediately before RIC and also be measured 5 minutes after RIC.	7 days
the heart rate during 7 days of RIC treatment.	the heart rate were measured immediately before RIC and also be measured 5 minutes after RIC.	7 days
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

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2017
• Primary Completion (Actual): October 30, 2017
• Study Completion (Actual): February 14, 2018

Study Registration Dates

• First Submitted: July 5, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): March 27, 2018
• Last Update Submitted That Met QC Criteria: March 24, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: RIC/rtPA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No