Thrombolysis and RIPC in Acute Ischemic Stroke

NCT ID: NCT03218293

Last Updated: 2021-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2020-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

RIPC device (IPC-906X)

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Thrombolysis

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guogang Luo, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 33028663 (View on PubMed)

Other Identifiers

XJTU1AF-CRF-2016-013

Identifier Type: -

Identifier Source: org_study_id