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Thrombolysis and RIPC in Acute Ischemic Stroke (tripcais)

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ClinicalTrials.gov Identifier: NCT03218293
Recruitment Status : Completed
First Posted : July 14, 2017
Last Update Posted : August 23, 2021
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

Brief Summary:
Remote ischemic postconditioning (RIPC) is suggested to protect the cerebral cell against ischemia in various settings. However, the effect of RIPC in patients with acute ischemic stroke who undergo thrombolysis has yet to be examined. In this single-center, randomized controlled trial, we examined the effect of RIPC on the resolution of nerve function deficient in response to thrombolysis. Patients in the RIPC group had five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm after thrombolysis. The primary endpoint was the recovery of nerve function deficient assessed by National Institutes of Health Stroke Scale(NIHSS), Activities of Daily Living(ADL), Modified Rankin Scale(mRS), CT cerebral perfusion imaging (CTP) and CT angiography(CTA). Secondary endpoints included the following: angiogenesis assessed by the level of vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF).

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke, Cerebral Embolism and Thrombosis Device: RIPC device (IPC-906X) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Recovery of Nerve Function Deficient of Combined Intravenous Thrombolysis and Remote Ischemic Post-conditioning in Acute Ischemic Stroke.
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : October 31, 2020
Actual Study Completion Date : October 31, 2020

Arm Intervention/treatment
Experimental: RIPC
Remote ischemic postconditioning(RIPC):Patients in the RIPC group not only receive foundational treatment but also have five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm using a RIPC device (IPC-906X; Beijing Renqiao Institute of Neuroscience, Beijing, China) after thrombolysis while in-hospital.
Device: RIPC device (IPC-906X)
Patients in the RIPC group had five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm after thrombolysis.
Other Name: Thrombolysis

No Intervention: Blank control group(BC)
Blank control group:Patients in the BC group only receive foundational treatment, including free radical elimination in the acute stage, blood pressure and blood glucose stabilization, and antiplatelet (aspirin, 100-300 mg/d) and lipid-lowering (atorvastatin, 20 mg/d) drugs,throughout the 14 days in-hospital period without remote ischemic postconditioning after thrombolysis.



Primary Outcome Measures :
  1. the percentage of patients with a favorable outcome, defined as a score of 0 or 1 on the modified Rankin scale (mRS). [ Time Frame: Day 90 ]

Secondary Outcome Measures :
  1. the percentage of functional recovery at discharge and at day 90, as measured by the NIHSS, the Barthel index (BI) and the mRS [ Time Frame: Day 90 and at discharge(up to day 14) ]
    we measured how many patients achieved a score of 0 or 1 for the NIHSS, 95 for the BI, and 0 - 2 for the mRS.

  2. Plasma biomarker concentrations [ Time Frame: Day 1 and at discharge ( up to day 14) ]
    Venous blood was drawn before the administration of IV tPA and at the end of hospitalization to determine the effect of repeated RIPC on anti-inflammatory (S100-β), vascular (VEGF, bFGF), anti-edema (MMP9), anti-oxidants (OH1) and other pathways (BDNF, HSP).


Other Outcome Measures:
  1. mortality rate [ Time Frame: up to 3 months. ]
    three-month mortality rate

  2. the rate of symptomatic hemorrhagic transformation [ Time Frame: up to 36 hours ]
    Defined by European Cooperative Acute Stroke Study III classification

  3. Early neurological deterioration [ Time Frame: up to 24 hours after IV tPA ]
  4. The tolerance index [ Time Frame: up to 14 days ]
    the proportion of patients that could complete every RIPC treatment session during his/her hospital stay.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • In accordance with the Guideline of Thrombolysis in Acute Ischemic Stroke and accomplish intravenous thrombolytic therapy using alteplase;
  • The consciousness of patients are conscious,somnolence,confusion and stupor,can comply better with the RIPC treatment;
  • Acute ischemic stroke confirmed by cranial CT/MRI;
  • Provision of written informed consent.

Exclusion criteria:

  • History of cerebral embolism,cerebral hemorrhage, brain tumor, brain trauma or other brain lesion;
  • Severe cardiac, liver, or kidney disease, malignancy, systemic organ dysfunction;
  • Blood pressure <90/60 mmHg or >200/110 mmHg after treatment;
  • Dementia or mental illness;
  • History of major surgery or trauma 4 weeks prior to admission;
  • Failure to provide informed consent.

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): NCT03218293


Locations
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China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China, 710061
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
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Principal Investigator: Guogang Luo, MD, PHD First Affiliated Hospital Xi'an Jiaotong University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT03218293    
Other Study ID Numbers: XJTU1AF-CRF-2016-013
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: August 23, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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
Intracranial Embolism
Intracranial Embolism and Thrombosis
Thrombosis
Embolism
Embolism and Thrombosis
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Infarction
Necrosis
Thromboembolism