NCT01654666

Brief 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 neuro-protective and anti-inflammatory effects on patients undergoing carotid artery stenting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 1, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
4 months until next milestone

Results Posted

Study results publicly available

November 11, 2015

Completed
Last Updated

November 11, 2015

Status Verified

October 1, 2015

Enrollment Period

2.5 years

First QC Date

July 23, 2012

Results QC Date

July 23, 2015

Last Update Submit

October 13, 2015

Conditions

Carotid Artery Stenosis

Keywords

Remote ischemic preconditioningStroke secondary preventionCarotid artery stentingCarotid stenosisInflammation

Outcome Measures

Primary Outcomes (2)

  • 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.

    Within six months after carotid artery stenting

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

    Within 48 hours after carotid artery stenting.

Secondary Outcomes (4)

  • Serum High-sensitive C-reactive Protein (Hs-CRP).

    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.

    From baseline to 6 months after treatment.

  • Serum Neuron Specific Enolase (NSE) Levels.

    Baseline, on admission, and 1 and 24 hours after carotid artery stenting.

  • Serum S-100B Levels.

    Baseline, on admission, and 1 and 24 hours after carotid artery stenting.

Study Arms (3)

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

Procedure: Remote ischemic preconditioningProcedure: Carotid Artery Stenting

Control group

ACTIVE COMPARATOR

Treatment:Patients in this group received standard medical therapy alone. Procedure: Carotid Artery Stenting

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

Procedure: Sham remote ischemic preconditioningProcedure: Carotid Artery Stenting

Interventions

Remote ischemic preconditioningPROCEDURE

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.

Also known as: RIPC
RIPC group
Sham remote ischemic preconditioningPROCEDURE

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.

Also known as: Sham RIPC
Sham RIPC group
Carotid Artery StentingPROCEDURE

Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.

Also known as: CAS
Control groupRIPC groupSham RIPC group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baojun Hou

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (2)

  • 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.

    PMID: 36645250DERIVED

  • 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.

    PMID: 28174194DERIVED

MeSH Terms

Conditions

Carotid StenosisInflammation

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Xunming Ji, M.D.,Ph.D
Organization
XuanWu Hospital, Capital Medical University
jixunming@vip.163.com
8683198127

Study Officials

  • Xunming Ji M.D., Ph.D.

    Capital Medical University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
XuanWu Hospital

Study Record Dates

First Submitted

July 23, 2012

First Posted

August 1, 2012

Study Start

July 1, 2012

Primary Completion

January 1, 2015

Study Completion

July 1, 2015

Last Updated

November 11, 2015

Results First Posted

November 11, 2015

Record last verified: 2015-10

Locations

CN(1)