Moyamoya DiseaseRIC-PMD-1NCT03821181
The Effect of RIC on TIA/Stroke in Children With Moyamoya Disease
A study testing RIC group in people with Moyamoya Disease and TIA, run by Capital Medical University at 1 site in China.
Trial summary
Moyamoya disease is a common reason of transient ischemic attack (TIA) and stroke in children. Remote ischemic conditioning (RIC) has been shown to prevent recurrent stroke in intracranial arterial stenosis, but it is unclear whether RIC can prevent TIA or stroke in children with moyamoya disease. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Moyamoya Disease, TIA, Children
- What is being tested?
- RIC group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2019to Aug 2020
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: ≥0 and ≤18
- all of the patients underwent digital subtraction angiography and met the current diagnostic criteria recommended by the Research Committee on MMD (Spontaneous Occlusion of the Circle of Willis) of the Ministry of Health and Welfare of Japan in 2012
- The CVR of patients detected by SPECT is not impaired severely
- The patients didn't suffer stroke before.
- Informed consent obtained from patient or acceptable patient's surrogate
Who cannot join
- Severe hepatic or renal dysfunction
- Severe hemostatic disorder or severe coagulation dysfunction
- Patients with unilateral MMD or the presence of secondary moyamoya phenomenon caused by autoimmune disease, Down syndrome, neurofibromatosis, leptospiral infection, or previous skull-base radiation therapy
- Any of the following cardiac disease - 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 participation
- Serious, advanced, or terminal illnesses with anticipated life expectancy of less than one year
- Patient participating in a study involving other drug or device trial study
Show all 9Show fewer
- Patients with existing neurological or psychiatric disease that would confound the neurological or functional evaluations
- Unlikely to be available for follow-up for 3 months
- Contraindication for RIC - severe soft-tissue injury, fracture, or peripheral vascular disease in the upper limbs.
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
About this study
Official title: Remote Ischemic Conditioning Prevents Ischemic Cerebrovascular Events In Children With Moyamoya Disease: A Randomized Controlled Trial
Moyamoya disease is a common reason of transient ischemic attack (TIA) and stroke in children. Remote ischemic conditioning (RIC) has been shown to prevent recurrent stroke in intracranial arterial stenosis, but it is unclear whether RIC can prevent TIA or stroke in children with moyamoya disease. This study aims to evaluate the effect of RIC on TIA/stroke in children with moyamoya disease.
Read the detailed description
This study will provide insights into the preliminary proof of principle, safety, and efficacy of RIC in pediatric MMD patients, and this data will provide parameters for future larger scale clinical trials if efficacious
- Conditions
- Moyamoya Disease, TIA, Children, Stroke
- Being tested
- RIC group, Sham group
- Keywords
- pediatric moyamoya disease, TIA, Stroke, Remote ischemic conditioning
- Medical subject headings
- Moyamoya Disease, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIC groupDevice
Patients allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 50 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs.
Sham groupDevice
patients allocated to the sham group will undergo a sham RIC procedure during which bilateral arm cuffs are inflated to a pressure of 30 mmHg for five cycles of 5 min, followed by 5 min of relaxation of the cuffs.
| Study group | Role | What they receive |
|---|---|---|
| RIC group | Experimental | Patients allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 50 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs. Receives: Device: RIC group |
| sham group | Sham comparator | patients allocated to the sham group will undergo a sham RIC procedure during which bilateral arm cuffs are inflated to a pressure of 30 mmHg for five cycles of 5 min, followed by 5 min of relaxation of the cuffs. Receives: Device: Sham group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of transient ischemic attack(TIA)
TIA means transient ischemic attack, two neurologists will evaluate patients with ischemic symptoms and make diagnosis.magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.
Measured: during baseline to 12months after therapy
The incidence rate of ischemic stroke
Two neurologists will evaluate patients with ischemic symptoms and make diagnosis.magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.
Measured: during baseline to 12months after therapy
Secondary outcomes (24)
Cerebral perfusion
cerebral perfusion status in the operation side at 12 months posttreatment as assessed by single photon emission computed tomography (SPECT).
Measured: change from baseline to 12months after therapy
The mean blood flow velocity of cerebral vascular detected by TCCD
TCCD means tran-scranial color-coded duplex sonography.
Measured: changes form baseline to 6months，12months after therapy
The score of National Institute of Health stroke scale score
National Institute of Health Stroke Scale (NIHSS) is considered as a standardized assessment of neurological functions in the acute phase of stroke, and it is generally used to quantify patient's neurological impairments on 15 items in 11 fields of different neurological status.The score of the scale ranges from 0 to 42.And higher score indicates worse neurological function.The NHISS will be assessed by certified study investigator, who is blinded to the treatment assignment.
Measured: during baseline to 12months after therapy
The score of Modified Rankin scale score
The Modified Rankin Scale Score (mRS) is the most comprehensive and most widely used primary outcome measurement to assess the neurological functional disability in contemporary acute stroke trials. The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranges from 0 (no symptom) to 5 (severe disability) and 6 (death). The investigators will use mRS to evaluate the degree of disability or dependence during daily activities. The mRS will be assessed by certified study investigator, who is blinded to the treatment assignment.
Measured: during baseline to 12months after therapy
Incidence rate of symptomatic intracerebral hemorrhage
Symptomatic intracranial hemorrhage, including any subarachnoid hemorrhage associated with clinical symptoms and symptomatic intracerebral hemorrhage. Head computed tomography or magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.
Measured: during baseline to 12months after therapy
The number of cerebral lacunar infarction
magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.
Measured: changes from baseline to 12months after therapy
The volume of cerebral lacunar infarction
magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.
Measured: changes from baseline to 12 months after therapy
The rate of death and adverse event
All causes of death will be included to compute mortality at 12 months after therapy
Measured: during baseline to 12months after therapy
Number of distal radial pulses
professional doctors will check the distal radial pulses
Measured: changes from baseline to 6, 12months after therapy
Visual inspection of local edema of fundus oculi
Professional oculists will visually inspect the fundus oculi to evaluate whether there is local edema.
Measured: changes from baseline to 6, 12months after therapy
The number of patients with erythema,and/or skin lesions related to RIC
Professional doctors will check it and the investigator will record the number.
Measured: changes from baseline to 6, 12months after therapy
Palpation for tenderness
Professional doctors will definite whether there's a palpation for tenderness
Measured: changes from baseline to 6, 12months after therapy
The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure
The investigator will record the number.
Measured: during baseline to 12months after therapy
The number of patients with any other adverse events related to RIC intervention
The investigator will record the number.
Measured: during baseline to 12months after therapy
The score of ABCD2
When subjects are diagnosed as TIA within 12 months after therapy ,The investigators use this scale to evaluate the patients' risk of stroke who with TIA .The score of the scale ranges from 0 to 7, and the higher score indicates higher risk of stroke in the patients who with TIA.The scale will be assessed by qualified investigator who are blinded to the treatment assignment.
Measured: during baseline to 12months after therapy
The level of S-100A4
Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
Measured: change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
The level of matrix metalloproteinase 9 (MMP-9)
Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
Measured: change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
The level of basic fibroblast growth factor
Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
Measured: change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
The level of platelet derived growth factor
Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
Measured: change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
The level of vascular endothelial growth factor
Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
Measured: change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
The level of hs-CRP(high-sensitive C-reactive protein)
Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
Measured: change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
cerebral perfusion examined by SPECT
cerebral perfusion status post-treatment will be assessed by single photon emission computed tomography (SPECT).
Measured: from baseline（pre-RIC treatment) to 12 months after therapy
cerebral perfusion examined by ASL
cerebral perfusion status post-treatment will be assessed by arterial spin labeling(ASL)
Measured: from baseline（pre-RIC treatment) to 12 months after therapy
variant of the RNF-213 gene
The investigators will save the blood sample in -20℃，and detect the variant RNF-213 gene
Measured: from baseline（pre-RIC treatment) to 12 months after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start8 Dec 2019 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moyamoya DiseaseStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- 307 Hospital of PLA
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821181
- Sponsor's protocol ID
- RIC-PMD-1
- Acronym
- RIC-PMD-1
- Status last verified
- Nov 2019
- First submitted
- 22 Jan 2019
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Conditioning Prevents Ischemic Cerebrovascular Events In Children With Moyamoya Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03821181
- Acronym / sponsor ID
- RIC-PMD-1 / RIC-PMD-1
- Conditions
- Moyamoya Disease, TIA, Children, Stroke
- Keywords
- pediatric moyamoya disease, TIA, Stroke, Remote ischemic conditioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- 307 Hospital of PLA
- Study start
- 8 Dec 2019 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 29 Jan 2019 (actual)
- 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.
Moyamoya disease is a common reason of transient ischemic attack (TIA) and stroke in children. Remote ischemic conditioning (RIC) has been shown to prevent recurrent stroke in intracranial arterial stenosis, but it is unclear whether RIC can prevent TIA or stroke in children with moyamoya disease. This study aims to evaluate the effect of RIC on TIA/stroke in children with moyamoya disease.
Detailed description
This study will provide insights into the preliminary proof of principle, safety, and efficacy of RIC in pediatric MMD patients, and this data will provide parameters for future larger scale clinical trials if efficacious
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC group | Experimental | Device: RIC groupPatients allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 50 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs. |
| sham group | Sham comparator | Device: Sham grouppatients allocated to the sham group will undergo a sham RIC procedure during which bilateral arm cuffs are inflated to a pressure of 30 mmHg for five cycles of 5 min, followed by 5 min of relaxation of the cuffs. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age: ≥0 and ≤18
- all of the patients underwent digital subtraction angiography and met the current diagnostic criteria recommended by the Research Committee on MMD (Spontaneous Occlusion of the Circle of Willis) of the Ministry of Health and Welfare of Japan in 2012
- The CVR of patients detected by SPECT is not impaired severely
- The patients didn't suffer stroke before.
- Informed consent obtained from patient or acceptable patient's surrogate
Key exclusion criteria (9 listed)
- Severe hepatic or renal dysfunction
- Severe hemostatic disorder or severe coagulation dysfunction
- Patients with unilateral MMD or the presence of secondary moyamoya phenomenon caused by autoimmune disease, Down syndrome, neurofibromatosis, leptospiral infection, or previous skull-base radiation therapy
- Any of the following cardiac disease - 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 participation
- Serious, advanced, or terminal illnesses with anticipated life expectancy of less than one year
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 |
|---|---|---|
| RIC groupPatients allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 50 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs. | Device | RIC group |
| Sham grouppatients allocated to the sham group will undergo a sham RIC procedure during which bilateral arm cuffs are inflated to a pressure of 30 mmHg for five cycles of 5 min, followed by 5 min of relaxation of the cuffs. | Device | sham group |
Primary outcome
The incidence rate of transient ischemic attack(TIA)
Time frame: during baseline to 12months after therapy
TIA means transient ischemic attack, two neurologists will evaluate patients with ischemic symptoms and make diagnosis.magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.
The incidence rate of ischemic stroke
Time frame: during baseline to 12months after therapy
Two neurologists will evaluate patients with ischemic symptoms and make diagnosis.magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.
24 secondary outcomes
Cerebral perfusion
Time frame: change from baseline to 12months after therapy
The mean blood flow velocity of cerebral vascular detected by TCCD
Time frame: changes form baseline to 6months，12months after therapy
The score of National Institute of Health stroke scale score
Time frame: during baseline to 12months after therapy
The score of Modified Rankin scale score
Time frame: during baseline to 12months after therapy
Incidence rate of symptomatic intracerebral hemorrhage
Time frame: during baseline to 12months after therapy
The number of cerebral lacunar infarction
Time frame: changes from baseline to 12months after therapy
The volume of cerebral lacunar infarction
Time frame: changes from baseline to 12 months after therapy
The rate of death and adverse event
Time frame: during baseline to 12months after therapy
Number of distal radial pulses
Time frame: changes from baseline to 6, 12months after therapy
Visual inspection of local edema of fundus oculi
Time frame: changes from baseline to 6, 12months after therapy
The number of patients with erythema,and/or skin lesions related to RIC
Time frame: changes from baseline to 6, 12months after therapy
Palpation for tenderness
Time frame: changes from baseline to 6, 12months after therapy
The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure
Time frame: during baseline to 12months after therapy
The number of patients with any other adverse events related to RIC intervention
Time frame: during baseline to 12months after therapy
The score of ABCD2
Time frame: during baseline to 12months after therapy
The level of S-100A4
Time frame: change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
The level of matrix metalloproteinase 9 (MMP-9)
Time frame: change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
The level of basic fibroblast growth factor
Time frame: change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
The level of platelet derived growth factor
Time frame: change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
The level of vascular endothelial growth factor
Time frame: change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
The level of hs-CRP(high-sensitive C-reactive protein)
Time frame: change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
cerebral perfusion examined by SPECT
Time frame: from baseline（pre-RIC treatment) to 12 months after therapy
cerebral perfusion examined by ASL
Time frame: from baseline（pre-RIC treatment) to 12 months after therapy
variant of the RNF-213 gene
Time frame: from baseline（pre-RIC treatment) to 12 months after therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIC group in people with Moyamoya Disease 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 5 inclusion and 9 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 20 Nov 2019. 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.
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 (108613911077166, Jixunming@vip.163.com;), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rate of transient ischemic attack(TIA) (time frame: during baseline to 12months after therapy). 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?
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 20 Nov 2019.