Acute Ischemic StrokePROTECTNCT05153655
Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy
A study testing Local ischemic post-conditioning in people with Acute Ischemic Stroke, run by Capital Medical University at 1 site in China.
Trial summary
Ischemic post-conditioning is a neuroprotective strategy that has been proven to attenuate reperfusion injury in animal models of stroke. The purpose of this proof-of-concept study is to determine the safety and tolerability of ischemic post-conditioning in patients with acute ischemic stroke who are treated with… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Local ischemic post-conditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2021to 15 Aug 2022
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years;
- Acute ischemic stroke caused by middle cerebral artery M1 segment occlusion;
- Successful recanalization (mTICI 2b/3) after endovascular thrombectomy that confirmed by digital subtraction angiography;
- Written informed consent provided by the patients or their legal relatives.
Who cannot join
- Known diagnosis or clinical suspicion of cerebral vasculitis or fibromuscular dysplasia;
- Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning;
- Stenting in the middle cerebral artery as rescue therapy during the thrombectomy procedures;
- > 2 times of balloon dilations as rescue therapy due to angioplasty during the thrombectomy procedures;
- Moderate or severe residual stenosis (≥ 50%) of the culprit artery after recanalization;
- Difficulty in complying with ischemic post-conditioning or other conditions that the investigator considered inappropriate for inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Tolerability of Local Ischemic Post-conditioning in Patients With Acute Ischemic Stroke After Mechanical Thrombectomy
Ischemic post-conditioning is a neuroprotective strategy that has been proven to attenuate reperfusion injury in animal models of stroke. The purpose of this proof-of-concept study is to determine the safety and tolerability of ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Local ischemic post-conditioning
- Keywords
- acute ischemic stroke, ischemic postconditioning, endovascular thrombectomy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local ischemic post-conditioningProcedure or surgery
Direct local ischemic post-conditioning will be applied after successful recanalization of the culprit middle cerebral artery. Local ischemic post-conditioning consists of briefly repeated 4 cycles of occlusion and reperfusion (equal duration) of the initially occluded culprit middle cerebral artery using a balloon. The schedule of advancing duration is 0 " 1 " 2 " 3 " 4 " 5 min.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic post-conditioning group | Experimental | The safety and tolerability of ischemic post-conditioning will be investigated using 3+3 dose-escalation trial design. Receives: Procedure: Local ischemic post-conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with major response
Major response is any of the following:
- Vessel perforation or rupture;
- Reocclusion of the culprit vessel after post-conditioning;
- Vessel dissection;
- Severe vasospasm;
- Ischemic post-conditioning related thrombotic events;
- Rupture of the balloon used for post-conditioning.
In the 3 + 3 design, 3 subjects are recruited for a given ischemic post-conditioning dose level. The trial is stopped if ≥ 2 of 3 subjects at a given dose level show major response. If only 1 of 3 subjects shows major response, 3 more subjects are recruited at a given dose level and a major response in any of them will stop the trial. Otherwise, same procedure is followed for the next ischemic post-conditioning dose level. Maximum tolerable dose will be the dose at the level before stopping of the trial.
Measured: Immediately after intervention on the day of ischemic post-conditioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start15 Dec 2021
- Primary completion15 Jul 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153655
- Sponsor's protocol ID
- PROTECT
- Acronym
- PROTECT
- Status last verified
- Jan 2023
- First submitted
- 29 Nov 2021
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.
Publications
Wu L, Wei M, Zhang B, Zhang B, Chen J, Wang S, Luo L, Liu S, Li S, Ren C, Hess DC, Song H, Zhao W, Ji X. Safety and Tolerability of Direct Ischemic Postconditioning Following Thrombectomy for Acute Ischemic Stroke. Stroke. 2023 Sep;54(9):2442-2445. doi: 10.1161/STROKEAHA.123.044060. Epub 2023 Jul 27.
PubMed 37497674Wu L, Zhang B, Zhao W, Ji X, Wei M. Ischemic post-conditioning in acute ischemic stroke thrombectomy: A phase-I duration escalation study. Front Neurosci. 2022 Dec 8;16:1054823. doi: 10.3389/fnins.2022.1054823. eCollection 2022.
PubMed 36523440
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Local Ischemic Post-conditioning in Patients With Acute Ischemic Stroke After Mechanical Thrombectomy
- ClinicalTrials.gov ID
- NCT05153655
- Acronym / sponsor ID
- PROTECT / PROTECT
- Conditions
- Acute Ischemic Stroke
- Keywords
- acute ischemic stroke, ischemic postconditioning, endovascular thrombectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 10 Dec 2021 (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.
Ischemic post-conditioning is a neuroprotective strategy that has been proven to attenuate reperfusion injury in animal models of stroke. The purpose of this proof-of-concept study is to determine the safety and tolerability of ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ischemic post-conditioning group | Experimental | Procedure: Local ischemic post-conditioningThe safety and tolerability of ischemic post-conditioning will be investigated using 3+3 dose-escalation trial design. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80 years;
- Acute ischemic stroke caused by middle cerebral artery M1 segment occlusion;
- Successful recanalization (mTICI 2b/3) after endovascular thrombectomy that confirmed by digital subtraction angiography;
- Written informed consent provided by the patients or their legal relatives.
Key exclusion criteria (6 listed)
- Known diagnosis or clinical suspicion of cerebral vasculitis or fibromuscular dysplasia;
- Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning;
- Stenting in the middle cerebral artery as rescue therapy during the thrombectomy procedures;
- > 2 times of balloon dilations as rescue therapy due to angioplasty during the thrombectomy procedures;
- Moderate or severe residual stenosis (≥ 50%) of the culprit artery after recanalization;
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 |
|---|---|---|
| Local ischemic post-conditioningDirect local ischemic post-conditioning will be applied after successful recanalization of the culprit middle cerebral artery. Local ischemic post-conditioning consists of briefly repeated 4 cycles of occlusion and reperfusion (equal duration) of the initially occluded culprit middle cerebral artery using a balloon. The schedule of advancing duration is 0 " 1 " 2 " 3 " 4 " 5 min. | Procedure or surgery | Ischemic post-conditioning group |
Primary outcome
Number of participants with major response
Time frame: Immediately after intervention on the day of ischemic post-conditioning
Major response is any of the following: * Vessel perforation or rupture; * Reocclusion of the culprit vessel after post-conditioning; * Vessel dissection; * Severe vasospasm; * Ischemic post-conditioning related thrombotic events; * Rupture of the balloon used for post-conditioning. In the 3 + 3 design, 3 subjects are recruited for a given ischemic post-conditioning dose level. The trial is stopped if ≥ 2 of 3 subjects at a given dose level show major response. If only 1 of 3 subjects shows major response, 3 more subjects are recruited at a given dose level and a major response in any of them will stop the trial. Otherwise, same procedure is followed for the next ischemic post-conditioning dose level. Maximum tolerable dose will be the dose at the level before stopping of the trial.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Derived from this study: PubMed 37497674Wu L, Wei M, Zhang B, Zhang B, Chen J, Wang S, Luo L, Liu S, Li S, Ren C, Hess DC, Song H, Zhao W, Ji X. Safety and Tolerability of Direct Ischemic Postconditioning Following Thrombectomy for Acute Ischemic Stroke. Stroke. 2023 Sep;54(9):2442-2445. doi: 10.1161/STROKEAHA.123.044060. Epub 2023 Jul 27.
- Derived from this study: PubMed 36523440Wu L, Zhang B, Zhao W, Ji X, Wei M. Ischemic post-conditioning in acute ischemic stroke thrombectomy: A phase-I duration escalation study. Front Neurosci. 2022 Dec 8;16:1054823. doi: 10.3389/fnins.2022.1054823. eCollection 2022.
- Individual participant dataSharing planned: Yes. Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local ischemic post-conditioning in people with Acute Ischemic Stroke, run by Capital Medical University 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 6 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: finished, as of the sponsor's last update on 4 Jan 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with major response (time frame: Immediately after intervention on the day of ischemic post-conditioning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05153655, which also lists 2 linked publications.
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 4 Jan 2023.