Thrombolysis and RIPC in Acute Ischemic Stroke

NCT03218293 | Completed DMC

• 1 other identifier: XJTU1AF-CRF-2016-013
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Ischemic Stroke, Cerebral Embolism and Thrombosis

Outcome Measures

Primary Outcomes (1)

• the percentage of patients with a favorable outcome, defined as a score of 0 or 1 on the modified Rankin scale (mRS).

  Day 90

Secondary Outcomes (2)

• the percentage of functional recovery at discharge and at day 90, as measured by the NIHSS, the Barthel index (BI) and the mRS

  Day 90 and at discharge(up to day 14)

• Plasma biomarker concentrations

  Day 1 and at discharge ( up to day 14)

Other Outcomes (4)

• mortality rate

  up to 3 months.

• the rate of symptomatic hemorrhagic transformation

  up to 36 hours

• Early neurological deterioration

  up to 24 hours after IV tPA

Study Arms (2)

RIPC

EXPERIMENTAL

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)

Blank control group(BC)

NO INTERVENTION

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.

Interventions

RIPC device (IPC-906X) DEVICE

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.

Also known as: Thrombolysis

RIPC

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, 710061, China

Location

Related Publications (1)

• An JQ, Cheng YW, Guo YC, Wei M, Gong MJ, Tang YL, Yuan XY, Song WF, Mu CY, Zhang AF, Saguner AM, Li GL, Luo GG. Safety and efficacy of remote ischemic postconditioning after thrombolysis in patients with stroke. Neurology. 2020 Dec 15;95(24):e3355-e3363. doi: 10.1212/WNL.0000000000010884. Epub 2020 Oct 7.

  PMID: 33028663 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Intracranial Embolism; Thrombosis

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Embolism and Thrombosis; Thromboembolism; Embolism and Thrombosis

Study Officials

• Guogang Luo, MD, PHD

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 14, 2017
• Study Start: August 1, 2017
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: August 23, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)