Phase 2
N=189
Protective Effects of Long-term Remote Limb Ischemic Preconditioning For Carotid Artery Stenting
Carotid Artery Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT01654666 ↗Enrolled (actual)
189
Serious AEs
4.3%
Results posted
Nov 2015
Primary outcome: Primary: Number of Patients With Cerebrovascular Events, Cardiovascular Events or Death. — 0; 2; 2; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Remote ischemic preconditioning (Procedure); Sham remote ischemic preconditioning (Procedure); Carotid Artery Stenting (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ji Xunming
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Cerebrovascular Events, Cardiovascular Events or Death. |
0; 2; 2; 1; 0; 1 | — |
| PRIMARY Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans. |
10; 26; 23; 42; 30; 31 | — |
| SECONDARY Serum High-sensitive C-reactive Protein (Hs-CRP). |
1.23; 1.22; 1.37; 0.99; 1.09; 1.35 | — |
| SECONDARY Number of Patients With Any Side Effects of Remote Ischemic Preconditioning (RIPC) Treatment. |
0; 0; 0 | — |
| SECONDARY Serum Neuron Specific Enolase (NSE) Levels. |
12.83; 12.51; 12.12; 12.63; 12.85; 12.56 | — |
| SECONDARY Serum S-100B Levels. |
49.64; 50.14; 50.42; 49.70; 50.75; 51.24 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT01654666). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.