Thrombolysis and RIPC in Acute Ischemic Stroke

Not Applicable

Completed

• Conditions: Acute Ischemic Stroke, Cerebral Embolism and Thrombosis
• Interventions: Device: RIPC device (IPC-906X)

• Registration Number: NCT03218293
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-06
• Study First Submitted QC: 2017-07-12
• Study First Posted: 2017-07-14
• Study Start: 2017-08-01
• Primary Completion: 2020-10-31
• Study Completion: 2020-10-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-19
• Last Update Posted: 2021-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIPC	RIPC device (IPC-906X)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)	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.
Plasma biomarker concentrations	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).

Trial Locations

Locations (1)

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, China