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

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ClinicalTrials.gov Identifier: NCT03231384
Recruitment Status : Completed
First Posted : July 27, 2017
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Ji Xunming, Capital Medical University

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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Device: Remote ischemic conditioning Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Feasibility of Rt-PA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke(rtPA-RIC1)
Actual Study Start Date : August 10, 2017
Actual Primary Completion Date : October 30, 2017
Actual Study Completion Date : February 14, 2018

Arm Intervention/treatment
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


No Intervention: Control group
The participants received r-tPA thrombolytic therapy after diagnosed ischemic stroke. In addition, all participants receive a standard clinical therapy.



Primary Outcome Measures :
  1. Feasibility of RIC after acute ischemic stroke [ Time Frame: 7 days ]
    The proportion of enrolled subjects that completed all the designed RIC procedures.


Secondary Outcome Measures :
  1. Objective signs of tissue or neurovascular injury [ Time Frame: within 7(±24h) days ]
    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

  2. Number of participants with intracranial hemorrhage in two groups [ Time Frame: 7(±24h)days ]
  3. Scores assessed by National Institutes of Health Stroke Scale(NIHSS) [ Time Frame: 7(±24h)days ]
  4. The functional outcome at 90 days assessed by modified Rankin scale (mRS). [ Time Frame: 90( ±7days) days ]
  5. functional outcome assessed by Barthel Index(BI) [ Time Frame: 90( ±7days)days ]
  6. cerebral infarct volume. [ Time Frame: 3-7 days after stroke onset ]
    The infarct volume of cerebral infarct is evaluated by cranial noncontrast MRI

  7. cerebral infarct volume. [ Time Frame: 3-7 days after stroke onset ]
    The infarct volume of cerebral infarct is evaluated by cranial noncontrast CT

  8. Cardiovascular parameters during 7 days of RIC treatment. [ Time Frame: 7 days ]
    the blood pressure were measured immediately before RIC and also be measured 5 minutes after RIC.

  9. the heart rate during 7 days of RIC treatment. [ Time Frame: 7 days ]
    the heart rate were measured immediately before RIC and also be measured 5 minutes after RIC.

  10. Levels of plasma myoglobin [ Time Frame: baseline and 7(±2)days ]
  11. Levels of serum IL-6 [ Time Frame: baseline and 7(±2)days ]
  12. Levels of serum HS-CRP [ Time Frame: baseline and 7(±2)days ]
  13. Levels of serum HCY [ Time Frame: baseline and 7(±2)days ]
  14. Any adverse events [ Time Frame: 90(±7)days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03231384


Locations
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China, XI Cheng District
Xuanwu Hospital, Capital Medical University
Beijing, XI Cheng District, China, 100053
Sponsors and Collaborators
Capital Medical University
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Responsible Party: Ji Xunming, professor, Capital Medical University
ClinicalTrials.gov Identifier: NCT03231384    
Other Study ID Numbers: RIC/rtPA
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Infarction
Necrosis