Ischemic Post-conditioning in the Treatment of Acute Ischemic Stroke

NCT06456437 | Recruiting DMC FDA Device

• 1 other identifier: TJHH-2023-WM26
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Ischemic Stroke; Large Vessel Occlusion; Intracranial Artery Occlusion With Cerebral Infarction; Endovascular Treatments

Keywords

Endovascular treatments; Acute ischemic stroke; Retrieved clots; Ischemic Post-conditioning; Stroke etiology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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)

  90 days after thrombectomy

• Postoperative 90 d mRS score (0-3 vs 4-6)

  90 days after thrombectomy

• Distribution of mRS scores at 90 d postoperatively

  90 days after thrombectomy

• NIHSS score at 24 h postoperatively

  24 hours after thrombectomy

Study Arms (2)

Post-ischemic adaptation to combined endovascular therapy

Device: Post-conditioning Balloon dilation and contraction

Endovascular therapy alone

Interventions

Post-conditioning Balloon dilation and contraction DEVICE

The 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.

Post-ischemic adaptation to combined endovascular therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute cerebral infarction receiving endovascular treatment

You may qualify if:

• )Ischemic stroke confirmed by CT or MRI of the head;
• \) 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);
• \) Recanalization of the occluded vessel at eTICI grade 2b/3 as confirmed by DSA after thrombectomy;
• )The patient/legally authorized representative has signed an informed consent form.

You may not qualify if:

• \) Inability to perform an MRI or CT scan for any reason;
• ）The patient has any condition that would interfere with neurologic assessment or psychiatric disorders;
• ）Stroke onset with seizures resulted in the inability to obtain an accurate NIHSS baseline;
• ）Pregnancy
• ）Other serious, advanced or terminal illness;

Sponsors & Collaborators

• Ming Wei: lead

Study Sites (1)

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Thrombosis specimens；Blood samples

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ming Wei, doctorate

  Tianjin Huanhu Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Wei, PhD

CONTACT

13502182903; drweiming@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Head of Neurosurgery, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 13, 2024
• Study Start: November 1, 2021
• Primary Completion: September 1, 2025
• Study Completion: December 31, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

CN (1)