Remote Ischemic ConditioningNCT05970653
Effect of RIC on Cerebral Autoregulation in Patients Undergoing Cerebrovascular Stent Implantation
A study testing Remote ischemic conditioning in people with Remote Ischemic Conditioning, run by Yi Yang at 1 site in China.
Trial summary
The purpose of this study is to determine the effect of remote ischemic conditioning on cerebral autoregulation in patients undergoing cerebrovascular stent implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Remote Ischemic Conditioning
- What is being tested?
- Remote ischemic conditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2023to 31 Aug 2024
- 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 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 symptomatic or asymptomatic cerebral vascular stenosis (including internal carotid artery system and vertebrobasilar system) who are candidates for elective cerebrovascular stenting.
- Patients or their immediate family members are able and willing to sign informed consent.
Who cannot join
- Patients with progressive stroke;
- mRS≥ 2 points before admission;
- Patients with other surgical treatments;
- Patients with other serious diseases or a life expectancy of less than 3 months
- Patients who had contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury in the upper extremities, venous thrombosis in the acute or subacute stage of upper extremities;
- Laboratory test indicators are unqualified: aspartate aminotransferase or alanine aminotransferase is 3 times higher than the upper limit of the normal range, blood creatinine > 265umol/L (>3mg/dl), platelet < 100×109/L, international normalized ratio (INR), activated partial thromboplastin time (APTT), prothrombin time (PT) exceed the upper limit of the normal range;
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- Pregnant or lactating women;
- Patients who are participating in other clinical studies, or who have participated in other clinical studies within 3 months prior to enrollment;
- Unwillingness to be followed up or poor adherence to treatment;
- Other circumstances that the investigator considers unsuitable for enrolment.
Trial locations and contacts
1 site in 1 country.
Zhenni Guo contact
China1 site, 1 recruiting
- Recruiting
First Hospital of Jilin University
Changchun, Jilin, 130000
Yi Yang, MD, PhD, 18186870008 ext. 0086, doctoryangyi@163.com
Zhenni Guo, MD, PhD, 18186872986 ext. 0086, zhen1ni2@163.com
About this study
Official title: Effect of Remote Ischemic Conditioning on Cerebral Autoregulation in Patients Undergoing Cerebrovascular Stent Implantation
The purpose of this study is to determine the effect of remote ischemic conditioning on cerebral autoregulation in patients undergoing cerebrovascular stent implantation.
Read the detailed description
In this study, 104 cases of patients with cerebrovascular stent implantation will be enrolled in the First Hospital of Jilin University, and they will be divided into the RIC group and the sham-RIC group. The RIC group received remote ischemic conditioning for 200mmHg, 2 times per day for 7 consecutive days or from enrollment to discharge. The sham-RIC group received remote ischemic conditioning for 60mmHg, 2 times per day for 7 consecutive days or from enrollment to discharge. Two groups will be followed up to evaluate the effect of remote ischemic conditioning on cerebral autoregulation in patients undergoing cerebrovascular stent implantation.
- Conditions
- Remote Ischemic Conditioning
- Being tested
- Remote ischemic conditioning, Sham remote ischemic conditioning
- Keywords
- Remote Ischemic Conditioning, Cerebrovascular Stent Implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioningProcedure or surgery
Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg.
Sham remote ischemic conditioningProcedure or surgery
Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg.
| Study group | Role | What they receive |
|---|---|---|
| RIC Group | Active comparator | Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 consecutive days or from enrollment to discharge. Receives: Procedure: Remote ischemic conditioning |
| Sham-RIC Group | Placebo comparator | Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 consecutive days or from enrollment to discharge. Receives: Procedure: Sham remote ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral autoregulation parameter
Cerebral autoregulation parameters derived from transfer function analysis. Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameter.
Measured: 0-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start2 Aug 2023
- Primary completion31 May 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Remote Ischemic ConditioningStudies 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
- 104 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970653
- Sponsor's protocol ID
- RICCA-CSI
- Status last verified
- Feb 2024
- First submitted
- 25 Jul 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hou YT, Xu BF, Zhang HM, Zhang P, He QY, Qu Y, Qi S, Liu J, Zhang PD, Zan W, Yang Y, Guo ZN. Efficacy of remote ischemic conditioning on cerebral blood flow regulation in patients with endovascular stenting: a randomized controlled trial. BMC Med. 2026 Jul 4. doi: 10.1186/s12916-026-05038-w. Online ahead of print.
PubMed 42401872
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Ischemic Conditioning on Cerebral Autoregulation in Patients Undergoing Cerebrovascular Stent Implantation
- ClinicalTrials.gov ID
- NCT05970653
- Acronym / sponsor ID
- RICCA-CSI
- Conditions
- Remote Ischemic Conditioning
- Keywords
- Remote Ischemic Conditioning, Cerebrovascular Stent Implantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Yi YangUniversity, hospital or other
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 1 Aug 2023 (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 determine the effect of remote ischemic conditioning on cerebral autoregulation in patients undergoing cerebrovascular stent implantation.
Detailed description
In this study, 104 cases of patients with cerebrovascular stent implantation will be enrolled in the First Hospital of Jilin University, and they will be divided into the RIC group and the sham-RIC group. The RIC group received remote ischemic conditioning for 200mmHg, 2 times per day for 7 consecutive days or from enrollment to discharge. The sham-RIC group received remote ischemic conditioning for 60mmHg, 2 times per day for 7 consecutive days or from enrollment to discharge. Two groups will be followed up to evaluate the effect of remote ischemic conditioning on cerebral autoregulation in patients undergoing cerebrovascular stent implantation.
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 Group | Active comparator | Procedure: Remote ischemic conditioningRemote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 consecutive days or from enrollment to discharge. |
| Sham-RIC Group | Placebo comparator | Procedure: Sham remote ischemic conditioningRemote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 consecutive days or from enrollment to discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age≥18 years, regardless of sex;
- Patients with symptomatic or asymptomatic cerebral vascular stenosis (including internal carotid artery system and vertebrobasilar system) who are candidates for elective cerebrovascular stenting.
- Patients or their immediate family members are able and willing to sign informed consent.
Key exclusion criteria (10 listed)
- Patients with progressive stroke;
- mRS≥ 2 points before admission;
- Patients with other surgical treatments;
- Patients with other serious diseases or a life expectancy of less than 3 months
- Patients who had contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury in the upper extremities, venous thrombosis in the acute or subacute stage of upper extremities;
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 (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. | Procedure or surgery | RIC Group |
| Sham remote ischemic conditioningRemote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. | Procedure or surgery | Sham-RIC Group |
Primary outcome
Cerebral autoregulation parameter
Time frame: 0-7 days
Cerebral autoregulation parameters derived from transfer function analysis. Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameter.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 42401872Hou YT, Xu BF, Zhang HM, Zhang P, He QY, Qu Y, Qi S, Liu J, Zhang PD, Zan W, Yang Y, Guo ZN. Efficacy of remote ischemic conditioning on cerebral blood flow regulation in patients with endovascular stenting: a randomized controlled trial. BMC Med. 2026 Jul 4. doi: 10.1186/s12916-026-05038-w. Online ahead of print.
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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.
Zhenni Guo contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic conditioning in people with Remote Ischemic Conditioning, run by Yi Yang 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 3 inclusion and 10 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 28 Feb 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Yang (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?
Cerebral autoregulation parameter (time frame: 0-7 days). 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 NCT05970653, which also lists 1 linked publication.
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 28 Feb 2024.