Carotid Artery OcclusionSERIC-HSNCT06702644
Safety and Efficacy of Remote Ischemic Conditioning in Patients with Chronic Internal Carotid Artery Occlusion Receiving Hybird Surgery: a Pilot, Randomized Controlled Trial
A study testing Remote ischemic conditioning in people with Carotid Artery Occlusion, run by Yi Yang.
Trial summary
The purpose of this study is to explore the safety and efficacy of remote ischemic conditioning in patients with internal carotid artery occlusion receiving hybird surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Occlusion
- What is being tested?
- Remote ischemic conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age≥18 years, regardless of sex
- Patients with chronic carotid artery occlusion who are going to undergo hybird surgery
- Can cooperate with and complete brain magnetic resonance imaging (MRI) examination
- Signed and dated informed consent is obtained
Who cannot join
- Hemorrhagic stroke
- Severe cardiac dysfunction or arrhythmia
- Uncontrolled hypertension (defined as systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg, despite medication taken at enrollment)
- Severe hepatic and renal dysfunction (defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 times higher than the upper limit of the normal range, creatinine >265umol/l (3mg/dl))
- The patients who have the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb. Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc.
- Pregnant or lactating women
- He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission
- Other conditions that the researchers think are not suitable for the group
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Zhenni Guo, MD, PhD contact
About this study
The purpose of this study is to explore the safety and efficacy of remote ischemic conditioning in patients with internal carotid artery occlusion receiving hybird surgery.
Read the detailed description
In this study, 60 patients with internal carotid artery occlusion receiving hybird surgery are included in our center in China. The experimental group will receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 6 consecutive days. The control group will receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day for 6 consecutive days. Two groups will be followed up for 90 days to evaluate the safety and efficacy of remote ischemic conditioning in patients with internal carotid artery occlusion receiving hybird surgery.
- Conditions
- Carotid Artery Occlusion
- Being tested
- Remote ischemic conditioning, Sham remote ischemic conditioning
- Keywords
- RIC, remote ischemic conditioning, carotid artery occlusion, hybird surgery, interventional surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioningDevice
Remote ischemic conditioning: Remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mmHg.
Sham remote ischemic conditioningDevice
Sham remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 60 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| RIC | Active comparator | Remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mmHg. RIC will be conducted twice daily for 6 consecutive days after enrollment. Receives: Device: Remote ischemic conditioning |
| Sham RIC | Placebo comparator | Sham remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mmHg. Sham RIC will be conducted twice daily for 6 consecutive days after enrollment. Receives: Device: Sham remote ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with new Diffusion Weighted Imaging (DWI) - positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.
Patients will undergo magnetic resonance imaging (including DWI) at baseline and 6 days after randomization.
Measured: 6 days
Secondary outcomes (5)
The number of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.
Patients will undergo magnetic resonance imaging (including DWI)at baseline and 6 days after randomization.
Measured: 6 days
The volume of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.
Patients will undergo magnetic resonance imaging(including DWI) at baseline and 6 days after randomization.
Measured: 6 days
Number of patients with cerebrovascular events, cardiovascular events or death
Cerebrovascular events include ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage. Cardiovascular events include angina and myocardial infarction. Death include all-cause of death.
Measured: 90±7 days
Proportion of patients with any side effects of RIC treatment.
The side effects referred to any side effects of RIC or sham RIC treatment, not including the sides effect of medications or hybrid surgery.
Measured: 6 days
Proportion of patients with any adverse events（including serious adverse events)
Adverse events due to any cause after enrollment of subjects in both groups.
Measured: 90±7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery OcclusionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Yang, The First Hospital of Jilin University
- Investigators
- Yi Yang, MD, PhD, Study chair, Neuroscience Center, Department of Neurology, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702644
- Sponsor's protocol ID
- SERIC-HS
- Acronym
- SERIC-HS
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Remote Ischemic Conditioning in Patients with Chronic Internal Carotid Artery Occlusion Receiving Hybird Surgery: a Pilot, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06702644
- Acronym / sponsor ID
- SERIC-HS / SERIC-HS
- Conditions
- Carotid Artery Occlusion
- Keywords
- RIC, remote ischemic conditioning, carotid artery occlusion, hybird surgery, interventional surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yi YangUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 25 Nov 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.
The purpose of this study is to explore the safety and efficacy of remote ischemic conditioning in patients with internal carotid artery occlusion receiving hybird surgery.
Detailed description
In this study, 60 patients with internal carotid artery occlusion receiving hybird surgery are included in our center in China. The experimental group will receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 6 consecutive days. The control group will receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day for 6 consecutive days. Two groups will be followed up for 90 days to evaluate the safety and efficacy of remote ischemic conditioning in patients with internal carotid artery occlusion receiving hybird surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC | Active comparator | Device: Remote ischemic conditioningRemote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mmHg. RIC will be conducted twice daily for 6 consecutive days after enrollment. |
| Sham RIC | Placebo comparator | Device: Sham remote ischemic conditioningSham remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mmHg. Sham RIC will be conducted twice daily for 6 consecutive days after enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age≥18 years, regardless of sex
- Patients with chronic carotid artery occlusion who are going to undergo hybird surgery
- Can cooperate with and complete brain magnetic resonance imaging (MRI) examination
- Signed and dated informed consent is obtained
Key exclusion criteria (8 listed)
- Hemorrhagic stroke
- Severe cardiac dysfunction or arrhythmia
- Uncontrolled hypertension (defined as systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg, despite medication taken at enrollment)
- Severe hepatic and renal dysfunction (defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 times higher than the upper limit of the normal range, creatinine >265umol/l (3mg/dl))
- The patients who have the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb. Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc.
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 ischemic conditioning: Remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mmHg. | Device | RIC |
| Sham remote ischemic conditioningSham remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 60 mmHg. | Device | Sham RIC |
Primary outcome
Proportion of patients with new Diffusion Weighted Imaging (DWI) - positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.
Time frame: 6 days
Patients will undergo magnetic resonance imaging (including DWI) at baseline and 6 days after randomization.
5 secondary outcomes
The number of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.
Time frame: 6 days
The volume of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.
Time frame: 6 days
Number of patients with cerebrovascular events, cardiovascular events or death
Time frame: 90±7 days
Proportion of patients with any side effects of RIC treatment.
Time frame: 6 days
Proportion of patients with any adverse events（including serious adverse events)
Time frame: 90±7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Zhenni Guo, MD, PhD contact
Yi Yang, MD, PhD study chair
Neuroscience Center, Department of Neurology, The First Hospital of Jilin University
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic conditioning in people with Carotid Artery Occlusion, run by Yi Yang.
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 8 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: opening soon, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Yang, MD, PhD (0086-13756661217, doctor_yangyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with new Diffusion Weighted Imaging (DWI) - positive lesions on post-treatment magnetic resonance imaging (MRI) Scans. (time frame: 6 days). 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 26 Nov 2024.