Clinical trial NCT04581759: Endovascular Treatment and RIPC in Acute Ischemic Stroke
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
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Ischemic Stroke
Endovascular Treatment
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Xi'an Jiaotong University
name: Shaanxi Provincial People's Hospital
name: Xijing Hospital
name: Tang-Du Hospital
name: Xi'an No.3 Hospital
name: Xi'an Gaoxin Hospital
First posted: 2020-10-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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；
2. Modified Rankin scale score (mRS) ≤1 before onset:
3. The Alberta Stroke Program Early CT score (ASPECTS)≥6 on admission;
4. National Institute of Health Stroke Scale (NIHSS) score ≥6 on admission;
5. Provision of written informed consent.

Exclusion Criteria:

1. CT or MRI scan showed significant midline deviation and the mass effect;
2. Glasgow(GCS) score ≤8 on admission;
3. failure to accomplish 3-months and 6-months follow up;
4. Severe cardiac, liver, or kidney disease, malignancy, severe coagulation dysfunction, severe anemia and systemic organ dysfunction;
5. Pregnant or nursing women, or patients with moderate to severe mental disorders or dementia;
6. 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.

Primary outcomes:
measure: Modified Rankin scale (mRS)
timeFrame: 7days, 90 days and 180 days after the surgery and at discharge
Secondary outcomes:
measure: The change of NIHSS score
timeFrame: 7days, 90 days and 180 days after the surgery and at discharge
measure: The change of Barthel Index
timeFrame: 7days, 90 days and 180 days after the surgery and at discharge
measure: The change of Montreal Cognitive Assessment (MoCA) score
timeFrame: 7days, 90 days and 180 days after the surgery and at discharge
measure: The change of MMSE score
timeFrame: 7days, 90 days and 180 days after the surgery and at discharge
measure: The change of inflammatory indicators
timeFrame: before ET, 24 hours and 7 days after the surgery
measure: The change of angiogenic factors
timeFrame: before ET, 24 hours and 7 days after the surgery
measure: The change of hemoglobin and Blood viscosity
timeFrame: up to 7 days after the surgery
measure: Postoperative hemorrhagic transformation
timeFrame: 72 hours after ET and hospitalization
measure: The change of MRI FLAIR Fazekas score
timeFrame: the changs from within 7 days to 90 days after the surgery
measure: The change of blood flow velocity
timeFrame: the changs from 24 hours after ET to 7 days after the surgery
measure: Vascular resistance
timeFrame: the changs from 24 hours after ET to 7 days after the surgery
measure: mortality rate
timeFrame: up to 90 days and 180 days
measure: recurrence rate of cerebrovascular disease
timeFrame: up to 90 days and 180 days
measure: blood pressure
timeFrame: up to 7days
measure: heart rate
timeFrame: up to 7days
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
References: