About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1)Ischemic stroke confirmed by CT or MRI of the head;
2) Large vessel occlusion confirmed by CTA or MRA of the head, including: intracranial internal carotid artery (ICA), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA), and posterior cerebral artery (PCA P1/P2);
3) Recanalization of the occluded vessel at eTICI grade 2b/3 as confirmed by DSA after thrombectomy;
4)The patient/legally authorized representative has signed an informed consent form.
Disqualifiers
1) Inability to perform an MRI or CT scan for any reason;
2)The patient has any condition that would interfere with neurologic assessment or psychiatric disorders;
3)Stroke onset with seizures resulted in the inability to obtain an accurate NIHSS baseline;
4)Pregnancy
Trial population
Patients with acute cerebral infarction receiving endovascular treatment
Trial design
Cohort
Prospective
Treatments tested in this trial
Post-conditioning Balloon dilation and contraction
DeviceThe balloon was filled at a pressure of no more than 4 atm at the original occlusion of the vessel to block blood flow for 2 minutes (confirmed by angiography), and then contracted to reperfuse the blood flow for 2 minutes, and the above steps were repeated 4 times to complete the in situ ischaemic post-acclimatisation intervention.
Treatment groups
Trial outcomes
Primary outcomes
Infarct volume at 24(-6/+12) h postoperatively
Infarct volume at 24(-6/+12) h postoperatively (CT/DWI, preferred DWI)
Secondary outcomes
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
Postoperative 90 d mRS score (0-2 vs 3-6)
Percentage of mRS scores 0-2 vs 3-6 at 90 d postoperatively
Postoperative 90 d mRS score (0-3 vs 4-6)
Percentage of mRS scores 0-3 vs 4-6 at 90 d postoperatively
Distribution of mRS scores at 90 d postoperatively
Distribution of mRS(modified Rankin scale)scores at 90 d postoperatively
Sponsors and contacts
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Ming Wei
Lead sponsor
Tianjin Huanhu Hospital
Sponsor institution