StrokePhase 1NCT01175876
The Effect Of Remote Limb Ischemic Preconditioning For Carotid Artery Stenting
A Phase 1 study testing remote limb ischemic preconditioning and Carotid Artery Stenting in people with Stroke and TIA, run by Capital Medical University at 1 site in China.
Trial summary
Remote limb ischemic preconditioning is neuro-protective and anti-inflammatory for ischemia- reperfusion injury. As the extent of its effect is unknown, the investigators will use clinical outcome, serum biochemical markers and diffusion-weighted magnetic resonance imaging (DW-MRI)to determine the extent of its… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke, TIA, Coronary Stenosis
- What is being tested?
- remote limb ischemic preconditioning and Carotid Artery Stenting
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jul 2010to Dec 2010
- Phase
- Phase 1
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Evolving stroke
- Untoward reaction to anesthesia
- Intolerance or allergic reaction to associated medications, including aspirin(ASA) and clopidogrel.
- Prior major ipsilateral stroke that may confound study endpoints.
- Severe dementia.
- Hemorrhagic transformation of an ischemic stroke within the past 60 days.
Show all 10Show fewer
- Chronic atrial fibrillation.
- MI within previous 30 days.
- High risk surgical candidate defined as the CREST test.
- Bilateral upper limb arteries are severe stenotic or occlusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yumin Luo
Beijing, Beijing Municipality, 100053
Yumin Luo, M.D.,Ph.D., 8683198129, yumin111@ccmu.edu.cn
About this study
Remote limb ischemic preconditioning is neuro-protective and anti-inflammatory for ischemia- reperfusion injury. As the extent of its effect is unknown, the investigators will use clinical outcome, serum biochemical markers and diffusion-weighted magnetic resonance imaging (DW-MRI)to determine the extent of its neuro-protective and anti-inflammatory effect.
Read the detailed description
BACKGROUND: Brain ischemia and injury contributed to perioperative morbidity and mortality in Carotid Artery Stenting. Remote ischemic preconditioning (RIPC) is a phenomenon whereby brief periods of ischemia followed by reperfusion in one organ provide systemic protection from prolonged ischemia. To investigate whether remote preconditioning protects the brain injury in patients undergoing elective Carotid Artery Stenting, a randomized trial will be performed in current study.
DESIGNING 60 patients will be randomized to Carotid Artery Stenting with RIPC group or conventional Carotid Artery Stenting group (control). RIPC consisted of five 5-min cycles of right upper arm ischemia/reperfusion, which was induced by an automated cuff-inflator placed on the right upper arm which was inflated to 200 mmHg for 5mins followed by deflating the cuff for 5mins. Cerebral injury was assessed by S-100b, NSE, hs-CRP and MMSE test in different time points.
- Conditions
- Stroke, TIA, Coronary Stenosis
- Being tested
- remote limb ischemic preconditioning, Carotid Artery Stenting
- Keywords
- MMSE, NSE, S100B, hsCRP, DWI-MRI
- Medical subject headings
- Stroke, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote limb ischemic preconditioningDevice
Remote limb ischemic preconditioning consisted of five 5-min cycles of right upper arm ischemia/reperfusion, which was induced by an automated cuff-inflator placed on the right upper arm which was inflated to 200 mmHg for 5mins followed by deflating the cuff for 5mins
Carotid Artery StentingProcedure or surgery
Carotid Artery Stenting is an invasive therapy of carotid stenosis.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Device: RIPC RIPC consisted of five 5-min cycles of right upper arm ischemia/reperfusion, which was induced by an automated cuff-inflator placed on the right upper arm which was inflated to 200 mmHg for 5mins followed by deflating the cuff for 5mins Procedure: Carotid Artery Stenting Receives: Device: remote limb ischemic preconditioning; Procedure: Carotid Artery Stenting |
| 2 | Sham comparator | Procedure: Carotid Artery Stenting Receives: Procedure: Carotid Artery Stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive disorder assessment
1.The Mini-Mental State Examination( MMSE) test: The difference in MMSE score among patients treated with preconditioning and those not treated.
Measured: 2 days
serum biomarkers
Serum biomarkers of brain injury and flammatory: The difference in NSE, S-100b and hs-CRP level among patients treated with preconditioning and those not treated.
Measured: 2 days
new brain lesions
The new lesions at DWI-MRI within postoperation 48 hours: The difference in new lesions in the DWI-MRI 48 hours postoperatively among patients treated with preconditioning and those not treated.
Measured: 2DAYS
Secondary outcomes (1)
composite endpoint of any stroke,MI,or death
The composite endpoint of any stroke ,MI, or death at 30-day and 90-day after the procedure.
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Xunming Ji, M.D.,Ph.D., Study chair, Proffessor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175876
- Sponsor's protocol ID
- RIPC2010
- Status last verified
- Aug 2010
- First submitted
- 3 Aug 2010
- Last updated
- 6 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Remote Limb Ischemic Preconditioning For Carotid Artery Stenting
- ClinicalTrials.gov ID
- NCT01175876
- Acronym / sponsor ID
- RIPC2010
- Conditions
- Stroke, TIA, Coronary Stenosis
- Keywords
- MMSE, NSE, S100B, hsCRP, DWI-MRI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2010 (estimated)
- First posted
- 5 Aug 2010 (estimated)
- 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.
Remote limb ischemic preconditioning is neuro-protective and anti-inflammatory for ischemia- reperfusion injury. As the extent of its effect is unknown, the investigators will use clinical outcome, serum biochemical markers and diffusion-weighted magnetic resonance imaging (DW-MRI)to determine the extent of its neuro-protective and anti-inflammatory effect.
Detailed description
BACKGROUND: Brain ischemia and injury contributed to perioperative morbidity and mortality in Carotid Artery Stenting. Remote ischemic preconditioning (RIPC) is a phenomenon whereby brief periods of ischemia followed by reperfusion in one organ provide systemic protection from prolonged ischemia. To investigate whether remote preconditioning protects the brain injury in patients undergoing elective Carotid Artery Stenting, a randomized trial will be performed in current study.
DESIGNING 60 patients will be randomized to Carotid Artery Stenting with RIPC group or conventional Carotid Artery Stenting group (control). RIPC consisted of five 5-min cycles of right upper arm ischemia/reperfusion, which was induced by an automated cuff-inflator placed on the right upper arm which was inflated to 200 mmHg for 5mins followed by deflating the cuff for 5mins. Cerebral injury was assessed by S-100b, NSE, hs-CRP and MMSE test in different time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: remote limb ischemic preconditioning, Procedure: Carotid Artery StentingDevice: RIPC RIPC consisted of five 5-min cycles of right upper arm ischemia/reperfusion, which was induced by an automated cuff-inflator placed on the right upper arm which was inflated to 200 mmHg for 5mins followed by deflating the cuff for 5mins Procedure: Carotid Artery Stenting |
| 2 | Sham comparator | Procedure: Carotid Artery StentingProcedure: Carotid Artery Stenting |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Evolving stroke
- Untoward reaction to anesthesia
- Intolerance or allergic reaction to associated medications, including aspirin(ASA) and clopidogrel.
- Prior major ipsilateral stroke that may confound study endpoints.
- Severe dementia.
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 limb ischemic preconditioningRemote limb ischemic preconditioning consisted of five 5-min cycles of right upper arm ischemia/reperfusion, which was induced by an automated cuff-inflator placed on the right upper arm which was inflated to 200 mmHg for 5mins followed by deflating the cuff for 5mins | Device | 1 |
| Carotid Artery StentingCarotid Artery Stenting is an invasive therapy of carotid stenosis. | Procedure or surgery | 1, 2 |
Primary outcome
cognitive disorder assessment
Time frame: 2 days
1.The Mini-Mental State Examination( MMSE) test: The difference in MMSE score among patients treated with preconditioning and those not treated.
serum biomarkers
Time frame: 2 days
Serum biomarkers of brain injury and flammatory: The difference in NSE, S-100b and hs-CRP level among patients treated with preconditioning and those not treated.
new brain lesions
Time frame: 2DAYS
The new lesions at DWI-MRI within postoperation 48 hours: The difference in new lesions in the DWI-MRI 48 hours postoperatively among patients treated with preconditioning and those not treated.
1 secondary outcome
composite endpoint of any stroke,MI,or death
Time frame: 3months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2010.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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. study chair
Proffessor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing remote limb ischemic preconditioning and Carotid Artery Stenting in people with Stroke and TIA, run by Capital Medical University 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 0 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 6 Aug 2010. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xunming Ji Ji, M.D.,Ph.D. (8683198127, jixm70@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive disorder assessment (time frame: 2 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2010.