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

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Remote ischemic conditioning
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Xuanwu Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

RIC group

Control group

Arm 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.

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

Outcomes

Primary Outcome Measures

Feasibility of RIC after acute ischemic stroke
The proportion of enrolled subjects that completed all the designed RIC procedures.

Secondary Outcome Measures

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
Number of participants with intracranial hemorrhage in two groups
Scores assessed by National Institutes of Health Stroke Scale(NIHSS)
The functional outcome at 90 days assessed by modified Rankin scale (mRS).
functional outcome assessed by Barthel Index(BI)
cerebral infarct volume.
The infarct volume of cerebral infarct is evaluated by cranial noncontrast MRI
cerebral infarct volume.
The infarct volume of cerebral infarct is evaluated by cranial noncontrast CT
Cardiovascular parameters during 7 days of RIC treatment.
the blood pressure were measured immediately before RIC and also be measured 5 minutes after RIC.
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.
Levels of plasma myoglobin
Levels of serum IL-6
Levels of serum HS-CRP
Levels of serum HCY
Any adverse events

Full Information

First Posted
July 5, 2017
Last Updated
March 24, 2018
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03231384
Brief Title
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

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
August 10, 2017 (Actual)
Primary Completion Date
October 30, 2017 (Actual)
Study Completion Date
February 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RIC group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The participants received r-tPA thrombolytic therapy after diagnosed ischemic stroke. In addition, all participants receive a standard clinical therapy.
Intervention Type
Device
Intervention Name(s)
Remote ischemic conditioning
Intervention Description
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
Primary Outcome Measure Information:
Title
Feasibility of RIC after acute ischemic stroke
Description
The proportion of enrolled subjects that completed all the designed RIC procedures.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Objective signs of tissue or neurovascular injury
Description
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
Time Frame
within 7(±24h) days
Title
Number of participants with intracranial hemorrhage in two groups
Time Frame
7(±24h)days
Title
Scores assessed by National Institutes of Health Stroke Scale(NIHSS)
Time Frame
7(±24h)days
Title
The functional outcome at 90 days assessed by modified Rankin scale (mRS).
Time Frame
90( ±7days) days
Title
functional outcome assessed by Barthel Index(BI)
Time Frame
90( ±7days)days
Title
cerebral infarct volume.
Description
The infarct volume of cerebral infarct is evaluated by cranial noncontrast MRI
Time Frame
3-7 days after stroke onset
Title
cerebral infarct volume.
Description
The infarct volume of cerebral infarct is evaluated by cranial noncontrast CT
Time Frame
3-7 days after stroke onset
Title
Cardiovascular parameters during 7 days of RIC treatment.
Description
the blood pressure were measured immediately before RIC and also be measured 5 minutes after RIC.
Time Frame
7 days
Title
the heart rate during 7 days of RIC treatment.
Description
the heart rate were measured immediately before RIC and also be measured 5 minutes after RIC.
Time Frame
7 days
Title
Levels of plasma myoglobin
Time Frame
baseline and 7(±2)days
Title
Levels of serum IL-6
Time Frame
baseline and 7(±2)days
Title
Levels of serum HS-CRP
Time Frame
baseline and 7(±2)days
Title
Levels of serum HCY
Time Frame
baseline and 7(±2)days
Title
Any adverse events
Time Frame
90(±7)days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
State/Province
XI Cheng District
ZIP/Postal Code
100053
Country
China

12. IPD Sharing Statement

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

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