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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03231384
• Other study ID #: RIC/rtPA
• Status: Completed
• Phase: N/A
• First received: July 5, 2017
• Last updated: March 24, 2018
• Start date: August 10, 2017
• Est. completion date: February 14, 2018

Study information

• Verified date: March 2018
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 14, 2018
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing	XI Cheng District

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of RIC after acute ischemic stroke	The proportion of enrolled subjects that completed all the designed RIC procedures.	7 days
Secondary	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
Secondary	Number of participants with intracranial hemorrhage in two groups		7(±24h)days
Secondary	Scores assessed by National Institutes of Health Stroke Scale(NIHSS)		7(±24h)days
Secondary	The functional outcome at 90 days assessed by modified Rankin scale (mRS).		90( ±7days) days
Secondary	functional outcome assessed by Barthel Index(BI)		90( ±7days)days
Secondary	cerebral infarct volume.	The infarct volume of cerebral infarct is evaluated by cranial noncontrast MRI	3-7 days after stroke onset
Secondary	cerebral infarct volume.	The infarct volume of cerebral infarct is evaluated by cranial noncontrast CT	3-7 days after stroke onset
Secondary	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
Secondary	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
Secondary	Levels of plasma myoglobin		baseline and 7(±2)days
Secondary	Levels of serum IL-6		baseline and 7(±2)days
Secondary	Levels of serum HS-CRP		baseline and 7(±2)days
Secondary	Levels of serum HCY		baseline and 7(±2)days
Secondary	Any adverse events		90(±7)days