Ischemic Post-conditioning in the Treatment of Acute Ischemic Stroke
NCT Number: NCT06456437
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Ischemic Stroke|Large Vessel Occlusion|Intracranial Artery Occlusion With Cerebral Infarction|Endovascular Treatments
Interventions: DEVICE: Post-conditioning Balloon dilation and contraction
Sponsor: Ming Wei
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-11-01
Completion Date: 2025-12-31
Locations: Tianjin Huanhu Hospital, Tianjin, Tianjin, China

Summary:
Post-ischemic adaptation is a physical brain protective treatment strategy in which an ischemic event in an organ or tissue is treated and blood flow is restored, and an ischemic stimulus is given to local tissues to induce the production of anti-ischemic damage factors and reduce the damage associated with reperfusion therapy . Relevant basic studies have confirmed that post-ischemic adaptation can reduce infarct volume and promote neurological function recovery in animal models of cerebral infarction. Therefore, it may be beneficial to the recovery of neurological function in patients with acute ischemic stroke undergoing mechanical thrombus extraction.

Based on the above background, the use of a balloon to repeatedly dilate-contract at the original occlusion site after revascularization to block and restore arterial flow may be an effective cerebroprotective treatment for patients with large-vessel occlusion who undergo thrombolysis. However, can this approach be safely used in patients with acute ischemic stroke treated with thrombolysis? What is the protocol for the length of time patients can tolerate post-ischemic adaptation? The application of this method in the treatment of acute ischemic stroke will be explored in this study.

Primary Outcome Measures: Infarct volume at 24(-6/+12) h postoperatively, Infarct volume at 24(-6/+12) h postoperatively (CT/DWI, preferred DWI), 24 (-6/+12) h postoperatively
Secondary Outcome Measures: Change in final cerebral infarct volume relative to baseline at 24 (-2/+12) hours postoperatively on CT/MR, Change in final cerebral infarct volume relative to baseline at 24 (-2/+12) hours postoperatively on CT/MR, 24 hours after thrombectomy|Postoperative 90 d mRS score (0-2 vs 3-6), Percentage of mRS scores 0-2 vs 3-6 at 90 d postoperatively, 90 days after thrombectomy|Postoperative 90 d mRS score (0-3 vs 4-6), Percentage of mRS scores 0-3 vs 4-6 at 90 d postoperatively, 90 days after thrombectomy|Distribution of mRS scores at 90 d postoperatively, Distribution of mRS（modified Rankin scale）scores at 90 d postoperatively, 90 days after thrombectomy|NIHSS score at 24 h postoperatively, NIHSS(National Institute of Health stroke scale) score at 24 h postoperatively, 24 hours after thrombectomy|Proportion of patients with a good prognosis early after treatment, Decrease in NIHSS score ≥ 8 or NIHSS score of 0-2 in 24 (-2/+12) hours, 24 hours after thrombectomy|NIHSS score at 7 d postoperatively/discharge, NIHSS(National Institute of Health stroke scale) score at 7 d postoperatively/discharge, 7 days after thrombectomy/time of discharge|Vascular recanalization, Postoperative revascularisation assessed by CTA/MRA/DSA using Arterial Occlusive Lesion (AOL) grading at 24 (-2/+12) hours postoperatively； Postoperative revascularisation assessed by CTA/MRA/DSA using modified Thrombolysis In Cerebral Infarction(mTICI) grading at 24 (-2/+12) hours postoperatively； Application of bedside TCD for assessment of revascularisation, 24 hours after thrombectomy|Haemodynamic assessment within 24 h postoperatively (confirmed by CTA, MRA, DSA or TCD), This was defined as an exploratory outcome: primary measures included CT or MR perfusion, dynamic contrast contrast-enhanced magnetic resonance (DCE MRI) or permeability surface (PS) detection of the blood-brain barrier., 24 hours after thrombectomy