Carotid Artery StenosisNCT05451030
Effect of Remote Ischemic Preconditioning on Cerebral Circulation Time in Patients With Severe Carotid Artery Stenosis (RIP-CCT)
A study testing remote ischemic preconditioning in people with Carotid Artery Stenosis, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
Cerebral circulation time in patients with severe carotid artery stenosis was found to be associated with hyperperfusion syndrome. Remote ischemic preconditioning can change the ability of cerebral autoregulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- remote ischemic preconditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2022to 6 Mar 2023
- 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 or older, regardless of gender;
- patients with severe carotid stenosis eligible for stenting (70-99% stenosis confirmed by DSA);
- non-responsible vessel stenosis <50% if bilateral carotid stenosis or combined posterior circulation stenosis is present;
- first DSA suggestive of ≥ 0.8 seconds difference (CCT on the affected side - CCT on the healthy side);
- baseline modified Rankin Scale (mRS) ≤ 2 points.
- signed the informed consent form.
Who cannot join
- baseline mRS ≥ 3 points;
- severe long-segment calcification of the carotid artery, severe distortion of aortic arch branches, anatomical variation of the aortic arch, and etc, which are not suitable for stenting
- spontaneous intracranial hemorrhage within 12 months;
- previous severe stroke or myocardial infarction within 3 months;
- active bleeding and coagulation disorders, which is contraindication to heparin and antiplatelet agents;
- a large intracranial aneurysm that cannot be treated simultaneously;
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- severe insufficiency of vital organs such as the heart, lungs, liver and kidneys, or malignant tumors with an expected survival cycle of less than six months;
- total occlusion of carotid artery without obvious cerebral ischemic symptoms
- unable to tolerate anesthesia;
- severe dementia;
- uncontrolled hypertension ;
- allergy to contrast media;
- pregnancy;
- being involved in studies with other drugs or instruments, etc;
- contraindications to remote ischemic preconditioning, such as those with more severe soft tissue injuries, fractures or vascular injuries in the upper extremity, or peripheral vascular lesions in the distal upper extremity.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, 110016
About this study
Official title: The Effect of Remote Ischemic Preconditioning on Cerebral Circulation Time in Patients With Severe Carotid Artery Stenosis (RIP-CCT): A Prospective, Randomized Controlled, Blind Outcome Evaluation, Multi-center Study
Cerebral circulation time in patients with severe carotid artery stenosis was found to be associated with hyperperfusion syndrome. Remote ischemic preconditioning can change the ability of cerebral autoregulation. The prospective, randomized controlled, blind outcome evaluation, multi-center study aimed to investigate the effect of remote ischemic preconditioning on cerebral circulation time in patients with severe carotid artery stenosis.
- Conditions
- Carotid Artery Stenosis
- Being tested
- remote ischemic preconditioning
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote ischemic preconditioningDevice
The cuff of a pneumatic electronic auto-control device placed around the bilateral upper limbs was used to deliver the protocol: 5 cycles of cuff inflation (200mmHg for 5 minutes) and deflation (for 5 minutes), for a total procedure time of 50 minutes, twice daily from the first DSA to the day of carotid artery stenting.
| Study group | Role | What they receive |
|---|---|---|
| remote ischemic preconditioning | Experimental | Not described Receives: Device: remote ischemic preconditioning |
| control group | Sham comparator | Not described Receives: Device: remote ischemic preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cerebral circulation time
Measured: pre-intervention
Secondary outcomes (3)
changes in contrast staining on brain computerized tomography after carotid artery stenting
Measured: 1 hours and 24 hours after carotid artery stenting
changes in collateral scoring based on digital subtraction angiography
Measured: pre-intervention
occurence of hyperperfusion syndrome after carotid artery stenting
Measured: 24 hours and 7 days after carotid artery stenting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start28 Jun 2022
- Primary completion6 Mar 2023
- Study completion6 Mar 2023
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 Carotid Artery StenosisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451030
- Sponsor's protocol ID
- Y (2022) 022
- Status last verified
- Mar 2023
- First submitted
- 5 Jul 2022
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu QY, Cui Y, Li W, Qiu J, Nguyen TN, Chen HS. Effect of remote ischemic preconditioning on cerebral circulation time in severe carotid artery stenosis: Results from the RIC-CCT trial. Cell Rep Med. 2024 Nov 19;5(11):101796. doi: 10.1016/j.xcrm.2024.101796. Epub 2024 Oct 28.
PubMed 39471820
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Remote Ischemic Preconditioning on Cerebral Circulation Time in Patients With Severe Carotid Artery Stenosis (RIP-CCT): A Prospective, Randomized Controlled, Blind Outcome Evaluation, Multi-center Study
- ClinicalTrials.gov ID
- NCT05451030
- Acronym / sponsor ID
- Y (2022) 022
- Conditions
- Carotid Artery Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 6 Mar 2023 (actual)
- First posted
- 11 Jul 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.
Cerebral circulation time in patients with severe carotid artery stenosis was found to be associated with hyperperfusion syndrome. Remote ischemic preconditioning can change the ability of cerebral autoregulation. The prospective, randomized controlled, blind outcome evaluation, multi-center study aimed to investigate the effect of remote ischemic preconditioning on cerebral circulation time in patients with severe carotid artery stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remote ischemic preconditioning | Experimental | Device: remote ischemic preconditioning |
| control group | Sham comparator | Device: remote ischemic preconditioning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 18 years or older, regardless of gender;
- patients with severe carotid stenosis eligible for stenting (70-99% stenosis confirmed by DSA);
- non-responsible vessel stenosis <50% if bilateral carotid stenosis or combined posterior circulation stenosis is present;
- first DSA suggestive of ≥ 0.8 seconds difference (CCT on the affected side - CCT on the healthy side);
- baseline modified Rankin Scale (mRS) ≤ 2 points.
Key exclusion criteria (15 listed)
- baseline mRS ≥ 3 points;
- severe long-segment calcification of the carotid artery, severe distortion of aortic arch branches, anatomical variation of the aortic arch, and etc, which are not suitable for stenting
- spontaneous intracranial hemorrhage within 12 months;
- previous severe stroke or myocardial infarction within 3 months;
- active bleeding and coagulation disorders, which is contraindication to heparin and antiplatelet agents;
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 preconditioningThe cuff of a pneumatic electronic auto-control device placed around the bilateral upper limbs was used to deliver the protocol: 5 cycles of cuff inflation (200mmHg for 5 minutes) and deflation (for 5 minutes), for a total procedure time of 50 minutes, twice daily from the first DSA to the day of carotid artery stenting. | Device | control group, remote ischemic preconditioning |
Primary outcome
Changes in cerebral circulation time
Time frame: pre-intervention
3 secondary outcomes
changes in contrast staining on brain computerized tomography after carotid artery stenting
Time frame: 1 hours and 24 hours after carotid artery stenting
changes in collateral scoring based on digital subtraction angiography
Time frame: pre-intervention
occurence of hyperperfusion syndrome after carotid artery stenting
Time frame: 24 hours and 7 days after carotid artery stenting
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 8 Mar 2023.
- Derived from this study: PubMed 39471820Liu QY, Cui Y, Li W, Qiu J, Nguyen TN, Chen HS. Effect of remote ischemic preconditioning on cerebral circulation time in severe carotid artery stenosis: Results from the RIC-CCT trial. Cell Rep Med. 2024 Nov 19;5(11):101796. doi: 10.1016/j.xcrm.2024.101796. Epub 2024 Oct 28.
- 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.
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 remote ischemic preconditioning in people with Carotid Artery Stenosis, run by General Hospital of Shenyang Military Region 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 6 inclusion and 15 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 8 Mar 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. 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?
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?
Changes in cerebral circulation time (time frame: pre-intervention). 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 NCT05451030, 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 8 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.