Acute Ischemic StrokeNCT06456437
Ischemic Post-conditioning in the Treatment of Acute Ischemic Stroke
An observational study of Acute Ischemic Stroke and Large Vessel Occlusion, run by Ming Wei at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Large Vessel Occlusion, Intracranial Artery Occlusion With Cerebral Infarction
- What is being tested?
- Post-conditioning Balloon dilation and contraction
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 31 Dec 2025
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute cerebral infarction receiving endovascular treatment
Who may be able to join
- 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.
Who cannot join
- 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
- 5）Other serious, advanced or terminal illness;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality
Ming Wei, 13502182903, drweiming@163.com
About this study
Official title: Ischemic Post-conditioning in the Treatment of Acute Ischemic Stroke--a Multicenter, Prospective Cohort Study
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.
Read the detailed description
Stroke has become the second leading cause of death in the world and the first cause of death and disability in adults in China; among them, ischemic stroke (AIS) accounts for about 80% of all strokes, and is the most important type of stroke . Ischemic stroke is usually caused by acute occlusion of cerebral blood vessels, therefore, opening the occluded blood vessels is the key to its treatment; at present, intravenous thrombolysis and endovascular mechanical thrombolysis are recommended by domestic and international guidelines for recanalization of blood vessels, and they have become the most effective treatment measures for ischemic stroke . However, due to the short therapeutic time window (<4.5 hours) and low recanalization rate of large vessel occlusion (less than 20%) of intravenous thrombolysis, endovascular mechanical thrombolysis is increasingly favored because of its long therapeutic time window, high recanalization rate of large vessel occlusion, and other advantages . However, although mechanical thrombolysis has a high rate of revascularization, the clinical prognosis of patients is not satisfactory, and both domestic and international studies have found that among patients treated with mechanical thrombolysis, the percentage of disability-free at 3 months is less than 30%, while the rate of death and disability is as high as more than 70% . The ischemia-reperfusion injury that occurs after revascularization may be the root cause of patients' still unsatisfactory prognosis . Therefore, trying to reduce ischemia-reperfusion injury after opening the occluded vessel to further improve the prognosis of patients is a scientific problem that needs to be solved urgently nowadays.
At present, scholars at home and abroad agree that effective neuroprotective therapy based on revascularization is expected to be an important treatment method to further improve the prognosis of patients with AIS, but there is no conclusion on how revascularization should be combined with neuroprotective therapy ; moreover, although a large number of studies have been carried out on neuroprotective therapy for acute ischemic stroke and hundreds of measures have been confirmed to have neuroprotective effects by animal experiments, the neuroprotective effects of such measures are not yet known. In addition, although a large number of studies have been conducted on neuroprotective therapy for acute ischemic stroke, and hundreds of measures have been demonstrated to be neuroprotective by animal experiments, there are still no clinically available neuroprotective measures .
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 . This method has been widely studied in the field of coronary heart disease rescue, and the results suggest that in situ ischemic post-adaptation immediately after coronary revascularization can safely and effectively reduce ischemia-reperfusion myocardial injury, reduce the size of myocardial infarction, and improve clinical prognosis . The process of mechanical thrombolysis for acute ischemic stroke is similar to that of emergency recanalization for acute coronary syndromes, and 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
- Being tested
- Post-conditioning Balloon dilation and contraction
- Keywords
- Endovascular treatments, Acute ischemic stroke, Retrieved clots, Ischemic Post-conditioning, Stroke etiology
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-conditioning Balloon dilation and contractionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Post-ischemic adaptation to combined endovascular therapy | Not described Receives: Device: Post-conditioning Balloon dilation and contraction | |
| Endovascular therapy alone | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct volume at 24(-6/+12) h postoperatively
Infarct volume at 24(-6/+12) h postoperatively (CT/DWI, preferred DWI)
Measured: 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
Change in final cerebral infarct volume relative to baseline at 24 (-2/+12) hours postoperatively on CT/MR
Measured: 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
Measured: 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
Measured: 90 days after thrombectomy
Distribution of mRS scores at 90 d postoperatively
Distribution of mRS（modified Rankin scale）scores at 90 d postoperatively
Measured: 90 days after thrombectomy
NIHSS score at 24 h postoperatively
NIHSS(National Institute of Health stroke scale) score at 24 h postoperatively
Measured: 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
Measured: 24 hours after thrombectomy
NIHSS score at 7 d postoperatively/discharge
NIHSS(National Institute of Health stroke scale) score at 7 d postoperatively/discharge
Measured: 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
Measured: 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.
Measured: 24 hours after thrombectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Nov 2021
- Primary completion1 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Ming Wei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ming Wei, Tianjin Huanhu Hospital
- Investigators
- Ming Wei, doctorate, Principal investigator, Tianjin Huanhu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456437
- Sponsor's protocol ID
- TJHH-2023-WM26
- Status last verified
- Jun 2024
- First submitted
- 30 May 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ischemic Post-conditioning in the Treatment of Acute Ischemic Stroke--a Multicenter, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06456437
- Acronym / sponsor ID
- TJHH-2023-WM26
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ming WeiUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Stroke has become the second leading cause of death in the world and the first cause of death and disability in adults in China; among them, ischemic stroke (AIS) accounts for about 80% of all strokes, and is the most important type of stroke . Ischemic stroke is usually caused by acute occlusion of cerebral blood vessels, therefore, opening the occluded blood vessels is the key to its treatment; at present, intravenous thrombolysis and endovascular mechanical thrombolysis are recommended by domestic and international guidelines for recanalization of blood vessels, and they have become the most effective treatment measures for ischemic stroke . However, due to the short therapeutic time window (<4.5 hours) and low recanalization rate of large vessel occlusion (less than 20%) of intravenous thrombolysis, endovascular mechanical thrombolysis is increasingly favored because of its long therapeutic time window, high recanalization rate of large vessel occlusion, and other advantages . However, although mechanical thrombolysis has a high rate of revascularization, the clinical prognosis of patients is not satisfactory, and both domestic and international studies have found that among patients treated with mechanical thrombolysis, the percentage of disability-free at 3 months is less than 30%, while the rate of death and disability is as high as more than 70% . The ischemia-reperfusion injury that occurs after revascularization may be the root cause of patients' still unsatisfactory prognosis . Therefore, trying to reduce ischemia-reperfusion injury after opening the occluded vessel to further improve the prognosis of patients is a scientific problem that needs to be solved urgently nowadays.
At present, scholars at home and abroad agree that effective neuroprotective therapy based on revascularization is expected to be an important treatment method to further improve the prognosis of patients with AIS, but there is no conclusion on how revascularization should be combined with neuroprotective therapy ; moreover, although a large number of studies have been carried out on neuroprotective therapy for acute ischemic stroke and hundreds of measures have been confirmed to have neuroprotective effects by animal experiments, the neuroprotective effects of such measures are not yet known. In addition, although a large number of studies have been conducted on neuroprotective therapy for acute ischemic stroke, and hundreds of measures have been demonstrated to be neuroprotective by animal experiments, there are still no clinically available neuroprotective measures .
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 . This method has been widely studied in the field of coronary heart disease rescue, and the results suggest that in situ ischemic post-adaptation immediately after coronary revascularization can safely and effectively reduce ischemia-reperfusion myocardial injury, reduce the size of myocardial infarction, and improve clinical prognosis . The process of mechanical thrombolysis for acute ischemic stroke is similar to that of emergency recanalization for acute coronary syndromes, and 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-ischemic adaptation to combined endovascular therapy | – | Device: Post-conditioning Balloon dilation and contraction |
| Endovascular therapy alone | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute cerebral infarction receiving endovascular treatment
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
- 5）Other serious, advanced or terminal illness;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post-conditioning Balloon dilation and contractionThe 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. | Device | Post-ischemic adaptation to combined endovascular therapy |
Primary outcome
Infarct volume at 24(-6/+12) h postoperatively
Time frame: 24 (-6/+12) h postoperatively
Infarct volume at 24(-6/+12) h postoperatively (CT/DWI, preferred DWI)
9 secondary outcomes
Change in final cerebral infarct volume relative to baseline at 24 (-2/+12) hours postoperatively on CT/MR
Time frame: 24 hours after thrombectomy
Postoperative 90 d mRS score (0-2 vs 3-6)
Time frame: 90 days after thrombectomy
Postoperative 90 d mRS score (0-3 vs 4-6)
Time frame: 90 days after thrombectomy
Distribution of mRS scores at 90 d postoperatively
Time frame: 90 days after thrombectomy
NIHSS score at 24 h postoperatively
Time frame: 24 hours after thrombectomy
Proportion of patients with a good prognosis early after treatment
Time frame: 24 hours after thrombectomy
NIHSS score at 7 d postoperatively/discharge
Time frame: 7 days after thrombectomy/time of discharge
Vascular recanalization
Time frame: 24 hours after thrombectomy
Haemodynamic assessment within 24 h postoperatively (confirmed by CTA, MRA, DSA or TCD)
Time frame: 24 hours after thrombectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Wei, doctorate principal investigator
Tianjin Huanhu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke and Large Vessel Occlusion, run by Ming Wei at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Wei, PhD (13502182903, drweiming@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct volume at 24(-6/+12) h postoperatively (time frame: 24 (-6/+12) h postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.