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Thrombolysis and RIPC in Acute Ischemic Stroke (tripcais)

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ClinicalTrials.gov Identifier: NCT03218293
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : March 16, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 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. vascular endothelial growth factor (VEGF), pg/ml [ Time Frame: From date of randomization until the date of 14 days and 3 months or date of death from any cause, whichever came first, assessed up to 12 months ]
  2. basic fibroblast growth factor (bFGF),pg/ml [ Time Frame: From date of randomization until the date of 14 days and 3 months or date of death from any cause, whichever came first, assessed up to 12 months ]

Secondary Outcome Measures :
  1. Change from baseline National Institute of Health stroke scale at 14 days, scores. [ Time Frame: 14 days ]
  2. Change from baseline Activities of Daily Living at 3 months, scores. [ Time Frame: 3 months ]


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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


Contacts
Contact: Guogang Luo, doctor 0086-13991974085 lguogang@163.com
Contact: Jiaqi An, master 0086-15309273807 1533846713@qq.com

Locations
China
The First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, China, 710061
Contact: Guogang Luo, Ph.D.    86-13991974085      
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University

Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT03218293     History of Changes
Other Study ID Numbers: XJTU1AF-CRF-2016-013
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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

Additional relevant MeSH terms:
Embolism and Thrombosis
Intracranial Embolism and Thrombosis
Stroke
Ischemia
Thrombosis
Cerebral Infarction
Embolism
Intracranial Embolism
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Thromboembolism