An interventional study of RIPC device (IPC-906X) and foundational treatment in Acute Ischemic Stroke and Endovascular Treatment, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-10.
Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Not applicable, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 300 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: RIPC device (IPC-906X) · Drug: foundational treatment
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.
Drug: foundational treatment
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.
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
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）
Time frame: 7days, 90 days and 180 days after the surgery and at discharge
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）
Time frame: 7days, 90 days and 180 days after the surgery and at discharge
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）
Time frame: 7days, 90 days and 180 days after the surgery and at discharge
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）
Time frame: 7days, 90 days and 180 days after the surgery and at discharge
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）
Time frame: 7days, 90 days and 180 days after the surgery and at discharge
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）
Time frame: before ET, 24 hours and 7 days after the surgery
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）
Time frame: before ET, 24 hours and 7 days after the surgery
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）
Time frame: up to 7 days after the surgery
Postoperative hemorrhagic transformation
The proportion of patients with postoperative hemorrhagic transformation, based on CT scan and symptom
Time frame: 72 hours after ET and hospitalization
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）
Time frame: the changs from within 7 days to 90 days after the surgery
The change of blood flow velocity
Vascular blood flow velocity measured by transcranial doppler （TCD） examination
Time frame: the changs from 24 hours after ET to 7 days after the surgery
Vascular resistance
Vascular resistance measured by TCD examination
Time frame: the changs from 24 hours after ET to 7 days after the surgery
mortality rate
90-days and 180-days mortality rate
Time frame: up to 90 days and 180 days
recurrence rate of cerebrovascular disease
90-days and 180-days recurrence rate of cerebrovascular disease
Time frame: up to 90 days and 180 days
blood pressure
The effect of RIPC on blood pressure
Time frame: up to 7days
heart rate
The effect of RIPC on heart rate
Time frame: up to 7days
Plan to share: Yes
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
First Affiliated Hospital Xi'an Jiaotong University