Carotid Artery StenosisPhase 2NCT01654666

Protective Effects of Long-term Remote Limb Ischemic Preconditioning For Carotid Artery Stenting

A Phase 2 study testing Remote ischemic preconditioning and Carotid Artery Stenting in people with Carotid Artery Stenosis, run by Ji Xunming at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Remote limb ischemic preconditioning (RIPC) has neuro-protective and anti-inflammatory effects on ischemia- reperfusion injury. As the extent of its effect is unknown, the investigators will use clinical outcome, serum biochemical markers and brain magnetic resonance imaging (MRI) to determine whether RIPC has… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Carotid Artery Stenosis
What is being tested?: Remote ischemic preconditioning and Carotid Artery Stenting
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 189 participants
Where: 1 siteChina
Study dates: Jul 2012to Jul 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Symptomatic or asymptomatic carotid artery stenosis. In symptomatic patients the degree of stenosis should more than 60% (Based on NASCET Criteria), in asymptomatic patients the degree of stenosis should more than 70% (Based on NASCET Criteria);
Tolerance to any of the study medications, including clopidogrel, aspirin and statins;
Can cooperate with and complete brain MRI examination;
Has a negative pregnancy test within 7 days before randomization and no childbearing potential;
Vascular ultrasound excluded intravascular thrombosis and unstable plaques in blood vessels of the bilateral upper limbs;
No hemorrhagic tendency;
Stable vital sign, normal renal and hepatic functions;
Informed consent.

Who cannot join

Evolving stroke;
Prior major ipsilateral stroke, if likely to confound study endpoints;
Severe dementia;
Hemorrhagic conversion of an ischemic stroke within the past 60 days;
Chronic atrial fibrillation;
Myocardial infarction within previous 30 days;

Show all 13Show fewer

Inability to understand and cooperate with study procedures or provide informed consent;
Participating in other device or drug trial that has not completed the required protocol follow-up period;
Any conditions that hampers proper angiographic assessment or makes percutaneous arterial access unsafe;
High risk candidates defined as the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST);
Any vascular, extremity soft tissue or orthopedic injury that may contraindicate bilateral arm ischemic preconditioning (e.g. superficial wounds and fractures of the arm);
Blood pressure cannot be controlled lower than 200 mmHg by medications;
Peripheral blood vessel disease (especially subclavian arterial and upper limb artery stenosis or occlusion).

Trial locations and contacts

1 site in 1 country.

China1 site

Baojun Hou
Beijing, Beijing Municipality, 100053

Other trials in China

About this study

Read the detailed description

BACKGROUND: Brain ischemia and injury contributed to perioperative morbidity and mortality in Carotid Artery Stenting. Remote ischemic preconditioning (RIPC), brief periods of ischemia followed by reperfusion, can provide systemic protection for prolonged ischemia. Our previous study found no significant protection to the patients who received once RIPC before Carotid Artery Stenting. In order to investigate whether long-term RIPC before Carotid Artery Stenting can protect these patients from the perioperative and long-term complications, a prospective randomized controlled trial will be performed in the current study.

DESIGNING: About 189 patients who are eligible for carotid artery stenting will be randomly assigned in 1:1:1 ratio to RIPC group, sham RIPC group and conventional Carotid Artery Stenting group (control). Remote limb ischemic preconditioning (RIPC) is consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, it is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min, patients in the RIPC group will do it twice a day for at least two weeks before carotid artery stenting. Patients in the sham RIPC group receive sham RIPC treatment, which is consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min, they will do it twice a day for at least two weeks before carotid artery stenting. Patients in the control group receive conventional carotid artery stenting without RIPC or sham RIPC treatment. Cerebral injury is assessed by serum S-100B and Neuron specific enolase (NSE), systematic inflammation is assessed by serum high-sensitivity C-reactive protein (hs-CRP). Post-treatment infarctions, both symptomatic and asymptomatic, are detected by diffusion-weighted imaging (DWI) and clinical outcomes are determined by cerebrovascular events, cardiac events or death.

Conditions: Carotid Artery Stenosis
Being tested: Remote ischemic preconditioning, Sham remote ischemic preconditioning, Carotid Artery Stenting
Keywords: Remote ischemic preconditioning, Stroke secondary prevention, Carotid artery stenting, Carotid stenosis, Inflammation
Medical subject headings: Carotid Stenosis, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Remote ischemic preconditioningProcedure or surgery
Also called RIPC
Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.
Sham remote ischemic preconditioningProcedure or surgery
Also called Sham RIPC
Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery StentingProcedure or surgery
Also called CAS
Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.

Study groups in NCT01654666
Study group	Role	What they receive
RIPC group	Experimental	Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment. Device:RIPC consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min,each patient in the RIPC group do it twice a day for at least two weeks before carotid artery stenting. Procedure: Carotid Artery Stenting Receives: Procedure: Remote ischemic preconditioning; Procedure: Carotid Artery Stenting
Control group	Active comparator	Treatment:Patients in this group received standard medical therapy alone. Procedure: Carotid Artery Stenting Receives: Procedure: Carotid Artery Stenting
Sham RIPC group	Sham comparator	Treatment:Patients in this group received standard medical therapy and sham remote ischemic preconditioning treatment. Device:Sham RIPC consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min, each patient in RIPC group do it twice a day for at least two weeks before carotid artery stenting. Procedure: Carotid Artery Stenting Receives: Procedure: Sham remote ischemic preconditioning; Procedure: Carotid Artery Stenting

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients With Cerebrovascular Events, Cardiovascular Events or Death.
Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and hyperperfusion syndrome. Cardiovascular events included angina and myocardial infarction.Death included any reason caused death.
Measured: Within six months after carotid artery stenting
Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans.
Measured: Within 48 hours after carotid artery stenting.

Secondary outcomes (4)

Serum High-sensitive C-reactive Protein (Hs-CRP).
Measured: Baseline, on admission, and 1 and 24 hours after carotid artery stenting.
Number of Patients With Any Side Effects of Remote Ischemic Preconditioning (RIPC) Treatment.
The side effects referred to any side effects of RIPC or sham RIPC treatment, not including the sides effect of medications and CAS.
Measured: From baseline to 6 months after treatment.
Serum Neuron Specific Enolase (NSE) Levels.
Measured: Baseline, on admission, and 1 and 24 hours after carotid artery stenting.
Serum S-100B Levels.
Measured: Baseline, on admission, and 1 and 24 hours 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.

Jul 2012Jul 2015

First posted1 Aug 2012 (estimated)
Study startJul 2012
Primary completionJan 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 189 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01654666
Sponsor's protocol ID: RIPC2012
Status last verified: Oct 2015
First submitted: 23 Jul 2012
Last updated: 11 Nov 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.
PubMed 36645250
Zhao W, Meng R, Ma C, Hou B, Jiao L, Zhu F, Wu W, Shi J, Duan Y, Zhang R, Zhang J, Sun Y, Zhang H, Ling F, Wang Y, Feng W, Ding Y, Ovbiagele B, Ji X. Safety and Efficacy of Remote Ischemic Preconditioning in Patients With Severe Carotid Artery Stenosis Before Carotid Artery Stenting: A Proof-of-Concept, Randomized Controlled Trial. Circulation. 2017 Apr 4;135(14):1325-1335. doi: 10.1161/CIRCULATIONAHA.116.024807. Epub 2017 Feb 7.
PubMed 28174194

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Protective Effects of Long-term Remote Limb Ischemic Preconditioning For Carotid Artery Stenting
ClinicalTrials.gov ID: NCT01654666
Acronym / sponsor ID: RIPC2012
Conditions: Carotid Artery Stenosis
Keywords: Remote ischemic preconditioning, Stroke secondary prevention, Carotid artery stenting, Carotid stenosis, Inflammation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 189 participants (actual)
Lead sponsor: Ji XunmingUniversity, hospital or other
Study start: Jul 2012
Primary completion: Jan 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 1 Aug 2012 (estimated)
Results: Posted 11 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
RIPC group	Experimental	Procedure: Remote ischemic preconditioning, Procedure: Carotid Artery StentingTreatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment. Device:RIPC consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min,each patient in the RIPC group do it twice a day for at least two weeks before carotid artery stenting. Procedure: Carotid Artery Stenting
Control group	Active comparator	Procedure: Carotid Artery StentingTreatment:Patients in this group received standard medical therapy alone. Procedure: Carotid Artery Stenting
Sham RIPC group	Sham comparator	Procedure: Sham remote ischemic preconditioning, Procedure: Carotid Artery StentingTreatment:Patients in this group received standard medical therapy and sham remote ischemic preconditioning treatment. Device:Sham RIPC consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min, each patient in RIPC group do it twice a day for at least two weeks before carotid artery stenting. Procedure: Carotid Artery Stenting

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Symptomatic or asymptomatic carotid artery stenosis. In symptomatic patients the degree of stenosis should more than 60% (Based on NASCET Criteria), in asymptomatic patients the degree of stenosis should more than 70% (Based on NASCET Criteria);
Tolerance to any of the study medications, including clopidogrel, aspirin and statins;
Can cooperate with and complete brain MRI examination;
Has a negative pregnancy test within 7 days before randomization and no childbearing potential;
Vascular ultrasound excluded intravascular thrombosis and unstable plaques in blood vessels of the bilateral upper limbs;

Key exclusion criteria (13 listed)

Evolving stroke;
Prior major ipsilateral stroke, if likely to confound study endpoints;
Severe dementia;
Hemorrhagic conversion of an ischemic stroke within the past 60 days;
Chronic atrial fibrillation;

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 preconditioningAlso: RIPCRemote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.	Procedure or surgery	RIPC group
Sham remote ischemic preconditioningAlso: Sham RIPCSham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.	Procedure or surgery	Sham RIPC group
Carotid Artery StentingAlso: CASCarotid Artery Stenting is an invasive therapy of carotid artery stenosis.	Procedure or surgery	Control group, RIPC group, Sham RIPC group

Primary outcome

Number of Patients With Cerebrovascular Events, Cardiovascular Events or Death.
Time frame: Within six months after carotid artery stenting
Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and hyperperfusion syndrome. Cardiovascular events included angina and myocardial infarction.Death included any reason caused death.
Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans.
Time frame: Within 48 hours after carotid artery stenting.

4 secondary outcomes

Serum High-sensitive C-reactive Protein (Hs-CRP).
Time frame: Baseline, on admission, and 1 and 24 hours after carotid artery stenting.
Number of Patients With Any Side Effects of Remote Ischemic Preconditioning (RIPC) Treatment.
Time frame: From baseline to 6 months after treatment.
Serum Neuron Specific Enolase (NSE) Levels.
Time frame: Baseline, on admission, and 1 and 24 hours after carotid artery stenting.
Serum S-100B Levels.
Time frame: Baseline, on admission, and 1 and 24 hours after carotid artery stenting.

Results and safety

Results posted to the registry on 11 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RIPC Group	63	48
Control Group	63	50
Sham RIPC Group	63	49

Primary outcome: Number of Patients With Cerebrovascular Events, Cardiovascular Events or Death.

Time frame: Within six months after carotid artery stenting. Number. Unit: participants

Measure	RIPC Group n = 48	Control Group n = 50	Sham RIPC Group n = 49
Ischemic stroke within 6 months	0	2	2
TIA within 6 months	1	0	1
No cerebrovascular event within 6 months	47	48	46
No Cardiovascular Events	47	48	46
No Deaths	47	48	46

Population analysed: The analysis population only included participants who fully completed the study.

Primary outcome: Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans.

Time frame: Within 48 hours after carotid artery stenting.. Number. Unit: participants

Measure	RIPC Group n = 52	Control Group n = 56	Sham RIPC Group n = 54
With new lesions on post-treatment scans	10	26	23
Without new lesions on post-treatment scans	42	30	31

Population analysed: The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through 6 months post carotid artery stenting.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RIPC Group	1 of 52 (1.9%)	10 of 52 (19.2%)	Not reported
Control Group	3 of 56 (5.4%)	26 of 56 (46.4%)	Not reported
Sham RIPC Group	3 of 54 (5.6%)	23 of 54 (42.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36645250Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.
Derived from this study: PubMed 28174194Zhao W, Meng R, Ma C, Hou B, Jiao L, Zhu F, Wu W, Shi J, Duan Y, Zhang R, Zhang J, Sun Y, Zhang H, Ling F, Wang Y, Feng W, Ding Y, Ovbiagele B, Ji X. Safety and Efficacy of Remote Ischemic Preconditioning in Patients With Severe Carotid Artery Stenosis Before Carotid Artery Stenting: A Proof-of-Concept, Randomized Controlled Trial. Circulation. 2017 Apr 4;135(14):1325-1335. doi: 10.1161/CIRCULATIONAHA.116.024807. Epub 2017 Feb 7.

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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.

Xunming Ji M.D., Ph.D. principal investigator

Capital Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Remote ischemic preconditioning and Carotid Artery Stenting in people with Carotid Artery Stenosis, run by Ji Xunming 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 8 inclusion and 13 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 11 Nov 2015. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Patients With Cerebrovascular Events, Cardiovascular Events or Death. (time frame: Within six months after carotid artery stenting). 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?

On the ClinicalTrials.gov record for NCT01654666, 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 11 Nov 2015.