Moyamoya DiseaseRIMENCT04064658
Effects of Remote Ischemic Pre-Conditioning in Moyamoya Disease Patients
A study testing Remote ischemic preconditioning and Encephaloduroarteriosynangiosis in people with Moyamoya Disease and Remote Ischemic Preconditioning, run by Beijing Tiantan Hospital at 2 sites in China.
Trial summary
In the present study, investigators evaluated whether RIPC reduce the major neurological complications in adult moyamoya disease patients undergoing encephaloduroarteriosynangiosis (EDAS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Moyamoya Disease, Remote Ischemic Preconditioning
- What is being tested?
- Remote ischemic preconditioning and Encephaloduroarteriosynangiosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 328 participants
- Where
- 2 sitesChina
- Study dates
- 1 Oct 2019to 1 Apr 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who diagnosed with moyamoya disease
- Adults 18 to 65 years of age
- The onset symptoms manifested as ischemic symptoms (TIA or stroke) or atypical symptoms (headache, epilepsy or asymptomatic)
- Able to receive the necessary imaging examination
- Patients who pre-agreed to the study
Who cannot join
- Prior cerebral hemorrhage history
- Other brain or cerebrovascular disease
- Previous history of revascularization surgery
- Dependent (mRS > 2)
- Receive other type of revascularization surgery
- Peripheral blood vessel disease (especially subclavian arterial and upper limb artery stenosis or occlusion).
- Patients who do not agree with the study
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Tiantan Hosiptal
Beijing, Beijing Municipality, 100070
Peking University International Hospital
Beijing, Beijing Municipality, 102206
About this study
Official title: Effects of Remote Ischemic Pre-Conditioning on Neurologic Complications in Adult Ischemic Moyamoya Disease Patients Undergoing Encephaloduroarteriosynangiosis
In the present study, investigators evaluated whether RIPC reduce the major neurological complications in adult moyamoya disease patients undergoing encephaloduroarteriosynangiosis (EDAS).
Read the detailed description
BACKGROUND: Brain ischemia and injury contributed to perioperative morbidity and mortality in revascularization surgery. Remote ischemic preconditioning (RIPC), brief periods of ischemia followed by reperfusion, can provide systemic protection for prolonged ischemia. Previous study found combined remote ischemic pre- and post-conditioning can be effective in reducing neurologic complications and the duration of hospitalization in moyamoya patients undergoing direct revascularization.In order to investigate whether RIPC before EDAS can protect these patients from the perioperative and long-term complications, a prospective randomized controlled trial will be performed in the current study.
DESIGNING: About 328 patients who are eligible for carotid artery stenting will be randomly assigned in 1:1 ratio to RIPC group and sham RIPC group (control). Remote limb ischemic preconditioning (RIPC) is consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, it is induced by a sphygmomanometer placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min, patients in the RIPC group will do it twice a day for at least five days before EDAS. Patients in the sham RIPC group receive sham RIPC treatment, which is consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, induced by a sphygmomanometer placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min, they will do it twice a day for at least five days before EDAS. Cerebral injury is assessed by plasma Human Soluble protein-100B (S-100B) and Neuron specific enolase (NSE). Clinical outcomes are determined by cerebrovascular events (including ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and transient neurological deficit) and death or dependent.
- Conditions
- Moyamoya Disease, Remote Ischemic Preconditioning
- Being tested
- Remote ischemic preconditioning, Sham remote ischemic preconditioning, Encephaloduroarteriosynangiosis
- Keywords
- Moyamoya Disease, Cerebrovascular Disorders, Arterial Occlusive Diseases, Ischemia
- Medical subject headings
- Moyamoya Disease, Cerebrovascular Disorders, Arterial Occlusive Diseases, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioningProcedure or surgery
Also called RIPC
Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by a sphygmomanometer placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.
Sham remote ischemic preconditioningProcedure or surgery
Also called Sham RIPC
Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by a sphygmomanometer placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.
EncephaloduroarteriosynangiosisProcedure or surgery
Also called EDAS
Encephaloduroarteriosynangiosis is an indirect revascularization surgery of moyamoya disease
| Study group | Role | What they receive |
|---|---|---|
| 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 a sphygmomanometer placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min, each patient in Sham RIPC group do it twice a day for at least five days before encephaloduroarteriosynangiosis.
Procedure: Encephaloduroarteriosynangiosis Receives: Procedure: Sham remote ischemic preconditioning; Procedure: Encephaloduroarteriosynangiosis |
| 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 a sphygmomanometer 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 five days before encephaloduroarteriosynangiosis.
Procedure: Encephaloduroarteriosynangiosis Receives: Procedure: Remote ischemic preconditioning; Procedure: Encephaloduroarteriosynangiosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Cerebrovascular Events.
Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and hyperperfusion syndrome.
Measured: postoperative one month
Number of Patients Dependent or Death
Dependent included the modified Rankin Scale (mRS) > 2. Death included any reason caused death.
Measured: postoperative one month
Secondary outcomes (7)
The Severity of the Ischemic Stroke after Surgery
The severity of the ischemic stroke was evaluated by the white matter hyperintensities volume on the MRI, the neurological deficits duration and the Modified Rankin Scale (mRS) of patients.
Measured: postoperative one month
Number of Patients Occured Re-stroke at Follow-up Period
Re-stroke included ischemic stroke and hemorrhagic stroke.
Measured: 6 months and 12 months after EDAS
Number of Patients Dependent or Death at Follow-up Period
Dependent included the modified Rankin Scale (mRS) > 2. Death included any reason caused death.
Measured: 6 months and 12 months after EDAS
Number of Patients with Improved Neurological Function at Follow-up Period
The modified Rankin Scale (mRS) decreased at the follow-up period compared to preoperative scores
Measured: 6 months and 12 months after EDAS
Perfusion Status of Patients at Follow-up Period
The perfusion status detected by stages of pre-infarction period based on computed tomography perfusion imaging
Measured: 6 months and 12 months after EDAS
Number of Patients With Any Side Effects of Remote Ischemic Preconditioning (RIPC) Treatment.
The side effects referred to any side effects of RIPC or sham RIPC treatment, not including the sides effect of medications and EDAS.
Measured: From baseline to 12 months after treatment
Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans.
The presence of ≥1 new brain lesions on DWI
Measured: Within 48 hours after EDAS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Why it stopped: waiting for the ethics approval of collaborator affiliation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moyamoya DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University International Hospital
- Responsible party
- Principal investigator, yuanli Zhao, Beijing Tiantan Hospital
- Investigators
- Yuanli Zhao, MD, Principal investigator, Beijing Tiantan HospitalRong Wang, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064658
- Sponsor's protocol ID
- RIPC2019
- Acronym
- RIME
- Status last verified
- Jul 2019
- First submitted
- 20 Aug 2019
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data (IPD) of this study are available from the principal investigator upon reasonable request.
Publications
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.
PubMed 36645250
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remote Ischemic Pre-Conditioning on Neurologic Complications in Adult Ischemic Moyamoya Disease Patients Undergoing Encephaloduroarteriosynangiosis
- ClinicalTrials.gov ID
- NCT04064658
- Acronym / sponsor ID
- RIME / RIPC2019
- Conditions
- Moyamoya Disease, Remote Ischemic Preconditioning
- Keywords
- Moyamoya Disease, Cerebrovascular Disorders, Arterial Occlusive Diseases, Ischemia
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: waiting for the ethics approval of collaborator affiliation
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Peking University International Hospital
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 22 Aug 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.
In the present study, investigators evaluated whether RIPC reduce the major neurological complications in adult moyamoya disease patients undergoing encephaloduroarteriosynangiosis (EDAS).
Detailed description
BACKGROUND: Brain ischemia and injury contributed to perioperative morbidity and mortality in revascularization surgery. Remote ischemic preconditioning (RIPC), brief periods of ischemia followed by reperfusion, can provide systemic protection for prolonged ischemia. Previous study found combined remote ischemic pre- and post-conditioning can be effective in reducing neurologic complications and the duration of hospitalization in moyamoya patients undergoing direct revascularization.In order to investigate whether RIPC before EDAS can protect these patients from the perioperative and long-term complications, a prospective randomized controlled trial will be performed in the current study.
DESIGNING: About 328 patients who are eligible for carotid artery stenting will be randomly assigned in 1:1 ratio to RIPC group and sham RIPC group (control). Remote limb ischemic preconditioning (RIPC) is consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, it is induced by a sphygmomanometer placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min, patients in the RIPC group will do it twice a day for at least five days before EDAS. Patients in the sham RIPC group receive sham RIPC treatment, which is consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, induced by a sphygmomanometer placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min, they will do it twice a day for at least five days before EDAS. Cerebral injury is assessed by plasma Human Soluble protein-100B (S-100B) and Neuron specific enolase (NSE). Clinical outcomes are determined by cerebrovascular events (including ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and transient neurological deficit) and death or dependent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham RIPC group | Sham comparator | Procedure: Sham remote ischemic preconditioning, Procedure: EncephaloduroarteriosynangiosisTreatment: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 a sphygmomanometer placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min, each patient in Sham RIPC group do it twice a day for at least five days before encephaloduroarteriosynangiosis. Procedure: Encephaloduroarteriosynangiosis |
| RIPC group | Experimental | Procedure: Remote ischemic preconditioning, Procedure: EncephaloduroarteriosynangiosisTreatment: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 a sphygmomanometer 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 five days before encephaloduroarteriosynangiosis. Procedure: Encephaloduroarteriosynangiosis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who diagnosed with moyamoya disease
- Adults 18 to 65 years of age
- The onset symptoms manifested as ischemic symptoms (TIA or stroke) or atypical symptoms (headache, epilepsy or asymptomatic)
- Able to receive the necessary imaging examination
- Patients who pre-agreed to the study
Key exclusion criteria (7 listed)
- Prior cerebral hemorrhage history
- Other brain or cerebrovascular disease
- Previous history of revascularization surgery
- Dependent (mRS > 2)
- Receive other type of revascularization surgery
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 ischemic preconditioningAlso: RIPCRemote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by a sphygmomanometer placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min. | Procedure or surgery | RIPC group |
| Sham remote ischemic preconditioningAlso: Sham RIPCSham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by a sphygmomanometer placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min. | Procedure or surgery | Sham RIPC group |
| EncephaloduroarteriosynangiosisAlso: EDASEncephaloduroarteriosynangiosis is an indirect revascularization surgery of moyamoya disease | Procedure or surgery | RIPC group, Sham RIPC group |
Primary outcome
Number of Patients With Cerebrovascular Events.
Time frame: postoperative one month
Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and hyperperfusion syndrome.
Number of Patients Dependent or Death
Time frame: postoperative one month
Dependent included the modified Rankin Scale (mRS) > 2. Death included any reason caused death.
7 secondary outcomes
The Severity of the Ischemic Stroke after Surgery
Time frame: postoperative one month
Number of Patients Occured Re-stroke at Follow-up Period
Time frame: 6 months and 12 months after EDAS
Number of Patients Dependent or Death at Follow-up Period
Time frame: 6 months and 12 months after EDAS
Number of Patients with Improved Neurological Function at Follow-up Period
Time frame: 6 months and 12 months after EDAS
Perfusion Status of Patients at Follow-up Period
Time frame: 6 months and 12 months after EDAS
Number of Patients With Any Side Effects of Remote Ischemic Preconditioning (RIPC) Treatment.
Time frame: From baseline to 12 months after treatment
Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans.
Time frame: Within 48 hours after EDAS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Derived from this study: PubMed 36645250Liang 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.
- Individual participant dataSharing planned: Yes. The individual participant data (IPD) of this study are available from the principal investigator upon reasonable request.
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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.
Yuanli Zhao, MD principal investigator
Beijing Tiantan Hospital
Rong Wang, MD principal investigator
Beijing Tiantan Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic preconditioning and Encephaloduroarteriosynangiosis in people with Moyamoya Disease and Remote Ischemic Preconditioning, run by Beijing Tiantan Hospital at 2 sites 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 7 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: paused, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Cerebrovascular Events. (time frame: postoperative one month). 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?
On the ClinicalTrials.gov record for NCT04064658, which also lists 1 linked publication.
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 19 Sep 2019.