Vertebrobasilar IschemiaNCT02971462
Remote Ischemic Conditioning for Reducing Stroke Risk of Symptomatic Vertebrobasilar Lesion of Atherosclerosis
A study testing ischemic conditioning in people with Vertebrobasilar Ischemia, run by Ji Xunming.
Trial summary
The purpose of this study is to investigate whether remote ischemic conditioning(RIC) would reduce the stroke risk of patients with symptomatic vertebrobasilar lesion of atherosclerosis,then we would observe the haemodynamics and plasma biomarkers changes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vertebrobasilar Ischemia
- What is being tested?
- ischemic conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Dec 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female with age from 18 to 80 years old.
- Patients having an ischemic stroke or a TIA within 30 days and with mRS score≤4 prior to randomization.
- The entry event is attributed to symptomatic atherosclerotic lesion（stenosis is greater than or equal to 50% or occlusion）in vertebrobasilar artery that is documented by magnetic resonance angiography (MRA) or computed tomographic angiography (CTA).
- Informed consent obtained.
Who cannot join
- Thrombolytic therapy within 24 hours prior to enrollment.
- Progressive neurological signs within 24 hours prior to enrollment.
- Cerebral venous thrombosis/stenosis.
- vertebrobasilar lesions due to arterial dissection, Moya Moya disease; any known vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other infection; any artery stenosis associated with cerebrospinal fluid (CSF) pleocytosis; radiation induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; post-partum angiopathy; suspected vasospastic process, suspected recanalized embolus.
- Any of the following unequivocal cardiac source of embolism: rheumatic mitral and or aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, patent foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis, or any other cardiovascular condition interfering with the participation.
- Uncontrolled severe hypertension [sitting systolic blood pressure (SBP) >180 mmHg and/or sitting diastolic blood pressure (DBP) >110 mmHg after medication].
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- Patients with serious complications or abnormal laboratory parameters: aspartate transaminase (AST) and/or alanine transaminase (ALT) >3×upper limit of normal range; creatinine clearance <0.6 ml/s and/or serum creatinine >265 μmol/l (>3.0 mg/dl); platelets <100×109/L.
- Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural) within 90 days prior to enrollment.
- Intracranial neoplasm, cerebral aneurysm or arteriovenous malformation.
- Known retinal hemorrhage or visceral bleeding within 30 days prior to enrollment.
- Severe hemostatic disorder or severe coagulation dysfunction.
- Subclavian arterial stenosis≥50% or subclavian steal syndrome.
- Previous treatment of target lesion with a stent, angioplasty, or other mechanical device, or plan to perform one of these procedures within 12 months after enrollment.
- Major surgery (including open femoral, aortic, or carotid surgery, cardiac) within previous 30 days or scheduled in the 6 months after enrollment.
- Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.
- Pregnant or breast-feeding women.
- Unwilling to be followed up or poor compliance for treatment.
- Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.
- Patients unsuitable for enrollment in the clinical trial according to investigators decision making.
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to investigate whether remote ischemic conditioning(RIC) would reduce the stroke risk of patients with symptomatic vertebrobasilar lesion of atherosclerosis,then we would observe the haemodynamics and plasma biomarkers changes.
- Conditions
- Vertebrobasilar Ischemia
- Being tested
- ischemic conditioning
- Keywords
- stroke, Vertebrobasilar atherosclerosis, remote ischemic conditioning
- Medical subject headings
- Vertebrobasilar Insufficiency, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ischemic conditioningDevice
Also called Doctormate, IPC-906
In this study, the remote ischemic conditioning treatment was composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which was induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation.
| Study group | Role | What they receive |
|---|---|---|
| RIC group | Experimental | Experimental: RIC group The upper limb ischemic conditioning is composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which is induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. This therapy started within 1 month after stroke. In addition, all participants receive a standard clinical therapy. Receives: Device: ischemic conditioning |
| Control group | No intervention | The participants receive a standard clinical therapy after diagnosed ischemic stroke. |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of ischemic cerebrovascular events with vertebrobasilar responsibility
ischemic cerebrovascular events include ischemic stroke and transient ischemic attack
Measured: 0-6 months from randomization
Secondary outcomes (5)
number of composite outcomes events
composite outcomes events include Number of ischemic stroke ，transient ischemic attack ，cerebral hemorrhage and mortality
Measured: 0-6 months from randomization
Number of participants with adverse events that are related to treatment
Measured: 0-6 months from randomization
number of participants with mRS 0-1
Measured: 0-6 months from randomization
changes of hemodynamics
hemodynamics evaluation by transcranial doppler
Measured: 0-6 months from randomization
changes of plasma biomarkers
changes of plasma VEGF and index of thromboelastogramat at the baseline，in the first 3 and 6 months
Measured: baseline，3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebrobasilar IschemiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ji Xunming
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ji Xunming, Capital Medical University
- Investigators
- Xunming Ji, MD. PhD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971462
- Sponsor's protocol ID
- RIC-SVAS
- Status last verified
- Nov 2016
- First submitted
- 16 Nov 2016
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Conditioning for Reducing Stroke Risk of Symptomatic Vertebrobasilar Lesion of Atherosclerosis
- ClinicalTrials.gov ID
- NCT02971462
- Acronym / sponsor ID
- RIC-SVAS
- Conditions
- Vertebrobasilar Ischemia
- Keywords
- stroke, Vertebrobasilar atherosclerosis, remote ischemic conditioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ji XunmingUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 23 Nov 2016 (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.
The purpose of this study is to investigate whether remote ischemic conditioning(RIC) would reduce the stroke risk of patients with symptomatic vertebrobasilar lesion of atherosclerosis,then we would observe the haemodynamics and plasma biomarkers changes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC group | Experimental | Device: ischemic conditioningExperimental: RIC group The upper limb ischemic conditioning is composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which is induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. This therapy started within 1 month after stroke. In addition, all participants receive a standard clinical therapy. |
| Control group | No intervention | –The participants receive a standard clinical therapy after diagnosed ischemic stroke. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female with age from 18 to 80 years old.
- Patients having an ischemic stroke or a TIA within 30 days and with mRS score≤4 prior to randomization.
- The entry event is attributed to symptomatic atherosclerotic lesion（stenosis is greater than or equal to 50% or occlusion）in vertebrobasilar artery that is documented by magnetic resonance angiography (MRA) or computed tomographic angiography (CTA).
- Informed consent obtained.
Key exclusion criteria (19 listed)
- Thrombolytic therapy within 24 hours prior to enrollment.
- Progressive neurological signs within 24 hours prior to enrollment.
- Cerebral venous thrombosis/stenosis.
- vertebrobasilar lesions due to arterial dissection, Moya Moya disease; any known vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other infection; any artery stenosis associated with cerebrospinal fluid (CSF) pleocytosis; radiation induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; post-partum angiopathy; suspected vasospastic process, suspected recanalized embolus.
- Any of the following unequivocal cardiac source of embolism: rheumatic mitral and or aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, patent foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis, or any other cardiovascular condition interfering with the participation.
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 |
|---|---|---|
| ischemic conditioningAlso: Doctormate, IPC-906In this study, the remote ischemic conditioning treatment was composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which was induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. | Device | RIC group |
Primary outcome
number of ischemic cerebrovascular events with vertebrobasilar responsibility
Time frame: 0-6 months from randomization
ischemic cerebrovascular events include ischemic stroke and transient ischemic attack
5 secondary outcomes
number of composite outcomes events
Time frame: 0-6 months from randomization
Number of participants with adverse events that are related to treatment
Time frame: 0-6 months from randomization
number of participants with mRS 0-1
Time frame: 0-6 months from randomization
changes of hemodynamics
Time frame: 0-6 months from randomization
changes of plasma biomarkers
Time frame: baseline，3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
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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, MD. PhD principal investigator
Xuanwu Hospital, Beijing
Questions about this trial
What is this clinical trial studying?
A study testing ischemic conditioning in people with Vertebrobasilar Ischemia, run by Ji Xunming.
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 4 inclusion and 19 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 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xunming Ji, MD. PhD (+86-10-83198952, jixunming@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of ischemic cerebrovascular events with vertebrobasilar responsibility (time frame: 0-6 months from randomization). 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 23 Nov 2016.