Intracranial ArteriosclerosisNCT05653505
Remote Ischemic Conditioning Combined With Endovascular Stenting for Symptomatic Intracranial Atherosclerotic Stenosis
An observational study of Intracranial Arteriosclerosis and Ischemic Preconditioning, run by Tianjin Huanhu Hospital at 1 site in China.
Trial summary
The purpose of this registry is to evaluate the safety and efficacy of RIC for patients with symptomatic intracranial atherosclerotic stenosis (sICAS) undergoing endovascular therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Arteriosclerosis, Ischemic Preconditioning, Endovascular Procedures
- What is being tested?
- Remote Ischemic Conditioning
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Jul 2026
- How long will I take part?
- 12 Months
- 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
- Adult, Older adult
Study population: This study prospectively collects data of patients with sICAS who receive endovascular therapy in the Comprehensive Neurovascular Ward of Tianjin Huanhu Hospital. Depending on their preference, patients enrolled in this registry will be divided into 2 groups, receiving either endovascular therapy alone or endovascular therapy plus RIC respectively.
Who may be able to join
- Patient admitted from Jan. 1st 2023 to Jan. 1st 2025;
- Age ≥ 18;
- Intracranial atherosclerosis stenosis measured as ≥70% by digital subtraction angiography or by other noninvasive methods, such as transcranial doppler, computed tomography angiography, or magnetic resonance angiography;
- A history of stroke/transient ischemic attack attributed to ICAS;
- Verbal and written informed consent is provided at the time of admission by patients or their legally authorized representatives.
Who cannot join
- Stenosis of other causes;
- Prior ipsilateral stroke with residual deficits;
- Uncontrolled hypertension (defined as systolic blood pressure ≥200 mm Hg despite medications at enrollment);
- Peripheral vascular disease (especially subclavian arterial and upper limb artery stenosis or occlusion).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Remote Ischemic Conditioning Combined With Endovascular Stenting in Patients With Symptomatic Intracranial Atherosclerotic Stenosis
The purpose of this registry is to evaluate the safety and efficacy of RIC for patients with symptomatic intracranial atherosclerotic stenosis (sICAS) undergoing endovascular therapy.
Read the detailed description
Intracranial atherosclerotic stenosis (ICAS) is one of the leading causes of ischemic stroke, and its incidence varies widely among different ethnic groups. ICAS may represent approximately 10% of ischemic stroke in Caucasians and even be responsible for up to 50% in Chinese population. Recurrent stroke risks are as high as 23% 1 year after transient ischemic stroke (TIA) or stroke in patients with a stenosis of 70% or more. The Chinese IntraCranial AtheroSclerosis (CICAS) study indicated the prevalence of ICAS was 46.6%; Patients with ICAS had more severe stroke at admission and stayed longer in hospitals compared with those without intracranial stenosis. After 12 months, recurrent stroke occurred in 3.27% of patients with no stenosis, in 3.82% for those with 50% to 69% stenosis, in 5.16% for those with 70% to 99% stenosis, and in 7.27% for those with total occlusion.
Current guidelines recommend best medical treatment (BMM) for patients with sICAS, which contains antithrombotic therapy, management of vascular risk factor (diabetes, lipids, and especially hypertension) and patient behaviors modification (diet, exercise and smoking cessation). But, even with the intervention of BMM, the recurrence of ischemic stroke or transient ischemic attacks (TIAs) in patients with sICAS still cannot be reduced. Endovascular therapy with intracranial angioplasty and/or stenting holds great promise as a treatment for sICAS. A recent trial found that, compared with bare-metal stent, drug-eluting stent reduced the risks of In-stent restenosis and ischemic stroke recurrence in patients with sICAS. However, endovascular therapy for patients with sICAS is known to be associated with potentially serious complications such as cerebral hyper-perfusion syndrome, intracranial hemorrhage, embolism and In-stent restenosis, etc. Those are the main reasons that affect the effect of endovascular therapy, thus limiting its application and popularization to a great degree.
Remote Ischemic Conditioning (RIC) is one of the most potent neuroprotective approaches that can minimize neuronal damage by protecting against ischemia-reperfusion injury and promote neuronal recovery by stimulating endogenous protective mechanism through transiently occluding the blood supply to non-significant organs or tissues such as limbs. The investigators see a promising future for RIC in facilitating further clinical translation and application due to its unique features of safety, simplicity and non-invasiveness. In recent years, the safety and efficacy of RIC on stroke intervention has been confirmed by a series of basic and clinical researches, among which RIC in combination with adjuvant drug therapy for sICAS-induced ischemic stroke patient improve cerebral blood flow and reduce stroke recurrence. Since its safety and efficacy has been verified, RIC can also be used to reduce the risks of In-stent restenosis for patients with carotid stent implantation and has extensive application prospects for patients with severe acute ischemic stroke treated with endovascular thrombectomy.
There is not enough evidence as to provide any specific recommendation regarding the use of RIC in sICAS patients, But we speculate that RIC has a certain effect on preventing perioperative complications for patients with sICAS undergoing endovascular therapy. Therefore, we intend to conduct this prospective cohort study to shed light on the utility of this promising therapy.
This study prospectively collects data of patients with sICAS who receive endovascular therapy in the Comprehensive Neurovascular Ward of Tianjin Huanhu Hospital. Depending on their preference, patients enrolled in this registry will be divided into 2 groups, receiving either endovascular therapy alone or endovascular therapy plus RIC respectively.
- Being tested
- Remote Ischemic Conditioning
- Keywords
- Remote Ischemic Conditioning, Endovascular Stenting, Symptomatic Intracranial Atherosclerotic Stenosis
- Medical subject headings
- Intracranial Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic ConditioningOther
Remote ischaemic conditioning (RIC) refers to a process whereby periods of intermittent ischemia, typically via the cyclical application of a blood pressure cuff to a limb at above systolic pressure, confers systemic protection against ischemia in spatially distinct vascular territories.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular therapy | According to current guideline recommendations, patients enrolled in this cohort will receive standardized perioperative management, endovascular therapy, and postoperative medical therapy. | |
| Endovascular therapy+Remote ischemic conditioning | Patients enrolled in this cohort will receive the same treatment as those in the endovascular therapy alone cohort as well as additional remote ischemic conditioning treatment.
Remote ischemic conditioning treatment protocol: RIC will be applied immediately after admission to the integrated neurovascular ward and the treatment continues until the patient is discharged, Once the patient is discharged, the choice of whether to continue RIC treatment depends on the patient's preference. RIC was induced through a standard blood pressure cuff placed around the non-paretic arm. The protocol includes 5 cycles of intermittent manually induced upper limb ischemia, alternating 5 minutes of inflation (20mmHg above systolic blood pressure), and 5 minutes of deflation twice a day. Receives: Other: Remote Ischemic Conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of ≥1 new brain lesions on DWI within 48 hours after endovascular stenting
A new brain lesion was diagnosed if increased signal intensity was visible on DWI with correspondent decreased signal on apparent diffusion coefficient.
Measured: 48 hours
Incidence of clinical adverse events within 12 months after endovascular stenting
Clinical adverse events include ischemic stroke, TIA, acute myocardial infarction,hemorrhagic stroke, hyperperfusion syndrome, and death.
Measured: 12 months
Secondary outcomes (4)
Number of new brain lesions on DWI within 48 hours after endovascular stenting
The number of new DWI lesions
Measured: 48 hours
The volume of new brain lesions on DWI within 48 hours after endovascular stenting
The volume of single lesions, and volume of all lesions were measured on DWI.
Measured: 48 hours
National Institutes of Health Stroke Scale (NIHSS) scores at 12 months
The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Measured: 12 months
Modified Rankin Scale (mRS) scores at 12 months
The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.functional disability.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial ArteriosclerosisStudies 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
- 160 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Tianjin Huanhu Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Wei, Tianjin Huanhu Hospital
- Investigators
- Ming Wei, PhD, Principal investigator, Tianjin Huanhu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653505
- Sponsor's protocol ID
- TJHH-2022-WM11
- Status last verified
- Dec 2022
- First submitted
- 8 Dec 2022
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Remote Ischemic Conditioning Combined With Endovascular Stenting in Patients With Symptomatic Intracranial Atherosclerotic Stenosis
- ClinicalTrials.gov ID
- NCT05653505
- Acronym / sponsor ID
- TJHH-2022-WM11
- Keywords
- Remote Ischemic Conditioning, Endovascular Stenting, Symptomatic Intracranial Atherosclerotic Stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Tianjin Huanhu HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 16 Dec 2022 (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.
The purpose of this registry is to evaluate the safety and efficacy of RIC for patients with symptomatic intracranial atherosclerotic stenosis (sICAS) undergoing endovascular therapy.
Detailed description
Intracranial atherosclerotic stenosis (ICAS) is one of the leading causes of ischemic stroke, and its incidence varies widely among different ethnic groups. ICAS may represent approximately 10% of ischemic stroke in Caucasians and even be responsible for up to 50% in Chinese population. Recurrent stroke risks are as high as 23% 1 year after transient ischemic stroke (TIA) or stroke in patients with a stenosis of 70% or more. The Chinese IntraCranial AtheroSclerosis (CICAS) study indicated the prevalence of ICAS was 46.6%; Patients with ICAS had more severe stroke at admission and stayed longer in hospitals compared with those without intracranial stenosis. After 12 months, recurrent stroke occurred in 3.27% of patients with no stenosis, in 3.82% for those with 50% to 69% stenosis, in 5.16% for those with 70% to 99% stenosis, and in 7.27% for those with total occlusion.
Current guidelines recommend best medical treatment (BMM) for patients with sICAS, which contains antithrombotic therapy, management of vascular risk factor (diabetes, lipids, and especially hypertension) and patient behaviors modification (diet, exercise and smoking cessation). But, even with the intervention of BMM, the recurrence of ischemic stroke or transient ischemic attacks (TIAs) in patients with sICAS still cannot be reduced. Endovascular therapy with intracranial angioplasty and/or stenting holds great promise as a treatment for sICAS. A recent trial found that, compared with bare-metal stent, drug-eluting stent reduced the risks of In-stent restenosis and ischemic stroke recurrence in patients with sICAS. However, endovascular therapy for patients with sICAS is known to be associated with potentially serious complications such as cerebral hyper-perfusion syndrome, intracranial hemorrhage, embolism and In-stent restenosis, etc. Those are the main reasons that affect the effect of endovascular therapy, thus limiting its application and popularization to a great degree.
Remote Ischemic Conditioning (RIC) is one of the most potent neuroprotective approaches that can minimize neuronal damage by protecting against ischemia-reperfusion injury and promote neuronal recovery by stimulating endogenous protective mechanism through transiently occluding the blood supply to non-significant organs or tissues such as limbs. The investigators see a promising future for RIC in facilitating further clinical translation and application due to its unique features of safety, simplicity and non-invasiveness. In recent years, the safety and efficacy of RIC on stroke intervention has been confirmed by a series of basic and clinical researches, among which RIC in combination with adjuvant drug therapy for sICAS-induced ischemic stroke patient improve cerebral blood flow and reduce stroke recurrence. Since its safety and efficacy has been verified, RIC can also be used to reduce the risks of In-stent restenosis for patients with carotid stent implantation and has extensive application prospects for patients with severe acute ischemic stroke treated with endovascular thrombectomy.
There is not enough evidence as to provide any specific recommendation regarding the use of RIC in sICAS patients, But we speculate that RIC has a certain effect on preventing perioperative complications for patients with sICAS undergoing endovascular therapy. Therefore, we intend to conduct this prospective cohort study to shed light on the utility of this promising therapy.
This study prospectively collects data of patients with sICAS who receive endovascular therapy in the Comprehensive Neurovascular Ward of Tianjin Huanhu Hospital. Depending on their preference, patients enrolled in this registry will be divided into 2 groups, receiving either endovascular therapy alone or endovascular therapy plus RIC respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular therapy | – | –According to current guideline recommendations, patients enrolled in this cohort will receive standardized perioperative management, endovascular therapy, and postoperative medical therapy. |
| Endovascular therapy+Remote ischemic conditioning | – | Other: Remote Ischemic ConditioningPatients enrolled in this cohort will receive the same treatment as those in the endovascular therapy alone cohort as well as additional remote ischemic conditioning treatment. Remote ischemic conditioning treatment protocol: RIC will be applied immediately after admission to the integrated neurovascular ward and the treatment continues until the patient is discharged, Once the patient is discharged, the choice of whether to continue RIC treatment depends on the patient's preference. RIC was induced through a standard blood pressure cuff placed around the non-paretic arm. The protocol includes 5 cycles of intermittent manually induced upper limb ischemia, alternating 5 minutes of inflation (20mmHg above systolic blood pressure), and 5 minutes of deflation twice a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study prospectively collects data of patients with sICAS who receive endovascular therapy in the Comprehensive Neurovascular Ward of Tianjin Huanhu Hospital. Depending on their preference, patients enrolled in this registry will be divided into 2 groups, receiving either endovascular therapy alone or endovascular therapy plus RIC respectively.
Key inclusion criteria (5 listed)
- Patient admitted from Jan. 1st 2023 to Jan. 1st 2025;
- Age ≥ 18;
- Intracranial atherosclerosis stenosis measured as ≥70% by digital subtraction angiography or by other noninvasive methods, such as transcranial doppler, computed tomography angiography, or magnetic resonance angiography;
- A history of stroke/transient ischemic attack attributed to ICAS;
- Verbal and written informed consent is provided at the time of admission by patients or their legally authorized representatives.
Key exclusion criteria (4 listed)
- Stenosis of other causes;
- Prior ipsilateral stroke with residual deficits;
- Uncontrolled hypertension (defined as systolic blood pressure ≥200 mm Hg despite medications at enrollment);
- Peripheral vascular disease (especially subclavian arterial and upper limb artery stenosis or occlusion).
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 |
|---|---|---|
| Remote Ischemic ConditioningRemote ischaemic conditioning (RIC) refers to a process whereby periods of intermittent ischemia, typically via the cyclical application of a blood pressure cuff to a limb at above systolic pressure, confers systemic protection against ischemia in spatially distinct vascular territories. | Other | Endovascular therapy+Remote ischemic conditioning |
Primary outcome
The presence of ≥1 new brain lesions on DWI within 48 hours after endovascular stenting
Time frame: 48 hours
A new brain lesion was diagnosed if increased signal intensity was visible on DWI with correspondent decreased signal on apparent diffusion coefficient.
Incidence of clinical adverse events within 12 months after endovascular stenting
Time frame: 12 months
Clinical adverse events include ischemic stroke, TIA, acute myocardial infarction,hemorrhagic stroke, hyperperfusion syndrome, and death.
4 secondary outcomes
Number of new brain lesions on DWI within 48 hours after endovascular stenting
Time frame: 48 hours
The volume of new brain lesions on DWI within 48 hours after endovascular stenting
Time frame: 48 hours
National Institutes of Health Stroke Scale (NIHSS) scores at 12 months
Time frame: 12 months
Modified Rankin Scale (mRS) scores at 12 months
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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, PhD 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 Intracranial Arteriosclerosis and Ischemic Preconditioning, run by Tianjin Huanhu Hospital 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 5 inclusion and 4 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 16 Dec 2022. 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?
The presence of ≥1 new brain lesions on DWI within 48 hours after endovascular stenting (time frame: 48 hours). The study lists 2 primary outcomes in all. 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 16 Dec 2022.