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Endovascular Treatment and RIPC in Acute Ischemic Stroke (EnTRIPS)

Primary Purpose

Acute Ischemic Stroke, Endovascular Treatment

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

RIPC device (IPC-906X)

foundational treatment

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

acute ischemic stroke（AIS） patients with large vessel occlusion (internal carotid artery system and vertebral basilar artery system) within 24 hours after onset, endovascular treatment (mechanical thrombotomy, intra-arterial thrombolysis, balloon dilatation or stent angioplastyand) successful opening were performed, and the definition of successful opening was defined by Modified Thrombolysis standard [Modified Thrombolysis in Cerebral infarction, mTICI]≥ 2B，The standards of endovascular interventional treatment are in line with the indications and contraindications formulated in the Chinese Guidelines for the Early Treatment of Acute Ischemic Stroke 2018；
Modified Rankin scale score (mRS) ≤1 before onset:
The Alberta Stroke Program Early CT score (ASPECTS)≥6 on admission;
National Institute of Health Stroke Scale (NIHSS) score ≥6 on admission;
Provision of written informed consent.

Exclusion Criteria:

CT or MRI scan showed significant midline deviation and the mass effect;
Glasgow(GCS) score ≤8 on admission;
failure to accomplish 3-months and 6-months follow up;
Severe cardiac, liver, or kidney disease, malignancy, severe coagulation dysfunction, severe anemia and systemic organ dysfunction;
Pregnant or nursing women, or patients with moderate to severe mental disorders or dementia;
Severe soft tissue injuries, fractures, thrombosis and other known peripheral vascular lesions of the upper limbs，active visceral hemorrhage, acute stage of fundus hemorrhage, cerebral aneurysm or cerebral arteriovenous malformation, and other unsuitable for bilateral upper arm compression.

Sites / Locations

First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

RIPC

foundational treatment group (FT)

Arm Description

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 endovascular treatment while in-hospital.

Patients in the FT group only receive foundational treatment, including free radical elimination in the acute stage, blood pressure and blood glucose stabilization, and antiplatelet (aspirin or/and clopidogrel,100-300mg/d) and lipid-lowering (atorvastatin 20-60mg/d,rosuvastatin 10-20mg/d) drugs, during the study period without remote ischemic postconditioning after endovascular treatment.

Outcomes

Primary Outcome Measures

Modified Rankin scale (mRS)

The percentage of patients with a favorable outcome from baseline at 90 days and 180 days postoperatively, defined as a score of 0 or 2 on the modified Rankin scale (mRS)（Notes:mRS score from 0-6, higher scores mean worse outcome）

Secondary Outcome Measures

The change of NIHSS score

The percentage of functional recovery from baseline at 90 days and 180 days postoperatively, as measured by the National Institute of Health Stroke Scale, short for NIHSS（Notes:NIHSS score from 0-42. higher scores mean worse outcome）

The change of Barthel Index

The change of functional recovery from baseline at 90 days and 180 days postoperatively, as measured by the Barthel Index （Notes:Barthel Index score from 0-100. higher scores mean better outcome）

The change of Montreal Cognitive Assessment (MoCA) score

The change of cognitive recovery from baseline at 90 days and 180 days postoperatively, as measured by the MoCA （Notes:MoCA score from 0-30. higher scores mean better outcome）

The change of MMSE score

The change of cognitive recovery from baseline at 90 days and 180 days postoperatively, as measured by the MMSE（Notes:MMSE score from 0-30. higher scores mean better outcome）

The change of inflammatory indicators

Peripheral venous blood was drawn before Endovascular Treatment(ET) and 24 hours and 7 days postoperatively to determine the effect of repeated RIPC on anti-inflammatory (hIL-1β、hIL-2R、hIL-6、hIL8、hIL-10、S100-β、TNF-α) （Notes: unit ng/ml）

The change of angiogenic factors

Peripheral venous blood was drawn before ET and 24 hours and 7 days postoperatively to determine the effect of repeated RIPC on vascular (VEGF、bFGF、EPO、HIF-1α、BDNF) and other pathways (S100B、NSE)（Notes: unit ng/ml）

The change of hemoglobin and Blood viscosity

Peripheral venous blood was drawn before ET and 24 hours and 7 days postoperatively to determine the effect of repeated RIPC on Hb and Blood viscosity（Notes: unit g/L , mPa.s）

Postoperative hemorrhagic transformation

The proportion of patients with postoperative hemorrhagic transformation, based on CT scan and symptom

The change of MRI FLAIR Fazekas score

Cerebral white matter demyelination measured by MRI FLAIR Fazekas score，（Notes:Fazekas score from 0-6. higher scores mean worse outcome）

The change of blood flow velocity

Vascular blood flow velocity measured by transcranial doppler （TCD） examination

Vascular resistance

Vascular resistance measured by TCD examination

mortality rate

90-days and 180-days mortality rate

recurrence rate of cerebrovascular disease

90-days and 180-days recurrence rate of cerebrovascular disease

blood pressure

The effect of RIPC on blood pressure

heart rate

The effect of RIPC on heart rate

Full Information

NCT ID

NCT04581759

First Posted

September 9, 2020

Last Updated

May 6, 2022

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Collaborators

Second Affiliated Hospital of Xi'an Jiaotong University, Shaanxi Provincial People's Hospital, Xijing Hospital, Tang-Du Hospital, Xi'an No.3 Hospital, Xi'an Gaoxin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04581759

Brief Title

Endovascular Treatment and RIPC in Acute Ischemic Stroke

Acronym

EnTRIPS

Official Title

Endovascular Treatment Combined With Remote Ischemic Postconditioning in Patients With Acute Ischemic Stroke Improves the Prognosis，a Multicenter, Randomized, Prospective Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 12, 2021 (Actual)

Primary Completion Date

April 30, 2023 (Anticipated)

Study Completion Date

October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Collaborators

Second Affiliated Hospital of Xi'an Jiaotong University, Shaanxi Provincial People's Hospital, Xijing Hospital, Tang-Du Hospital, Xi'an No.3 Hospital, Xi'an Gaoxin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Endovascular treatment（ET）is an effective therapy for acute ischemic stroke(AIS) with great vessel obstruction. However, acute complications such as high postoperative perfusion injury, hemorrhagic transformation and restenosis resulted in functional independence in only about 50% of patients 90 days after interventional surgery. Therefore, it is very important to protect the neurologic function after emergency endovascular treatment. The investigators' previous studies have shown that combined with intravenous thrombolytic therapy and remote postconditioning（RIPC）can significantly improve the neurological impairment and short-term and long-term prognosis in patients with acute stroke. In this multicenter, randomized controlled trial, the investigators assumed patients with acute ischemic stroke who had successfully revascularization after ET might benefit from RIPC as well. Patients in the RIPC group had five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm after ET. The primary endpoint measure was the proportion of patients with a favorable recovery of nerve function deficient assessed by Modified Rankin Scale （mRS≤2） 90 days after surgery. Secondary endpoints included the following: (1) Symptom endpoints: Neurological intelligence and function scores, postoperative hemorrhagic transformation rate, etc. (2) Blood index test: postoperative inflammatory factors, neuron-specific enolase (NSE) and other indicators. (3) Imaging endpoints: MRI-FLAIR , TCD, etc.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Ischemic Stroke, Endovascular Treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RIPC

Arm Type

Experimental

Arm Description

Arm Title

foundational treatment group (FT)

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

RIPC device (IPC-906X)

Intervention Description

Patients in the RIPC group will have five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm twice a day after Mechanical Thrombectomy.

Intervention Type

Drug

Intervention Name(s)

foundational treatment

Intervention Description

foundational treatment, including free radical elimination in the acute stage, blood pressure and blood glucose stabilization, and antiplatelet (aspirin or/and clopidogrel ) and lipid-lowering (statins) drugs

Primary Outcome Measure Information:

Title

Modified Rankin scale (mRS)

Description

Time Frame