Moyamoya DiseaseNCT05860946
Remote Ischemic Conditioning in Adult Moyamoya Disease Patients
A study testing Remote ischemic conditioning in people with Moyamoya Disease and Remote Ischemic Conditioning, run by Huashan Hospital.
Trial summary
Remote ischemic conditioning (RIC) is a non-invasive therapeutic approach for protecting organs or tissue against the detrimental effects of acute ischemia-reperfusion injury. Many protective factors produced by the stimulus of RIC could protect remote target organs and tissues through inhibiting oxidation and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Moyamoya Disease, Remote Ischemic Conditioning
- What is being tested?
- Remote ischemic conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 Dec 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 aged from 18 to 65 years old;
- Subjects all performed digital subtraction angiography (DSA) and diagnosed with MMD accroding to the criteria recommended by the Research Committee on MMD (Spontaneous Occlusion of the Circle of Wills) of the Ministry of Health and Welfare of Japan in 201211.
- Modified Rankin Scale (mRS) score<4;
- Informed consent obtained from the patient or legally authorized representative.
Who cannot join
- Subjects suffered from acute ischemic or hemorrhagic stroke within 3 months;
- Severe hepatic or renal dysfunction;
- Severe cardiac disease;
- Severe hemostatic disorder or severe coagulation dysfunction;
- Serious, advanced, or terminal illnesses with anticipated life expectancy of less than one year;
- Patients with moyamoya syndrome caused by autoimmune disease, Down syndrome, neurofibromatosis, leptospiral infection, or previous skull-base radiation therapy;
About this study
Official title: Safety and Efficacy of Remote Ischemic Conditioning in Adult Moyamoya Disease Patients Undergoing Revascularization Surgery
Remote ischemic conditioning (RIC) is a non-invasive therapeutic approach for protecting organs or tissue against the detrimental effects of acute ischemia-reperfusion injury. Many protective factors produced by the stimulus of RIC could protect remote target organs and tissues through inhibiting oxidation and inflammation. The phenomenon of this protect effect was first found in myocardium ischemia-reperfusion injury and then RIC was used in children cardiac surgery to provide myocardial protection during operation. Then RIC was gradually applied to brain protection and a series of clinical researches have confirmed that it could improve the cerebral perfusion status, increase cerebral tolerance to ischemic injury, reduce perihematomal edema and promote clearance. Recently, a randomized controlled study reported that daily RIC could improve cerebral perfusion and slow arterial progression of adult MMD. Meanwhile, a single-arm open-label study also indicated that RIC was a promising noninvasive method for ischemic MMD control by relieving symptoms and reducing stroke recurrence. In addition, the effects of RIC on reducing neurological complications in MMD patients treated with revascularization surgery has also been reported. However, the mechanism of RIC in reducing peri-operative complications for MMD patients is still unknown. Thus, we conducted a randomized controlled study to explore the safety and efficacy of RIC in adult MMD patients undergoing revascularization therapy
- Conditions
- Moyamoya Disease, Remote Ischemic Conditioning
- Being tested
- Remote ischemic conditioning
- Medical subject headings
- Moyamoya Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioningDevice
The RIC intervention included five cycles of 5 min inflating tourniquets with the pressure of 200 mmHg and 5 min deflating with pressure of 0 mmHg alternately
| Study group | Role | What they receive |
|---|---|---|
| RIC group | Experimental | Patients in RIC group and control group will achieve RIC intervention and sham RIC intervention three times daily from 5 days before operation and 7 days post operation Receives: Device: Remote ischemic conditioning |
| Control group | Sham comparator | Patients in control group, bilateral upper arm cuffs were inflated to a pressure of 60 mm Hg for 5 minutes, followed by 5 minutes of relaxation of the cuffs Receives: Device: Remote ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of major neurologic complications during perioperative period
Measured: 2 weeks after operation
Secondary outcomes (1)
The Modified Rankin Scale (MRS) score
Measured: at 90 days postoperation and at 1 year after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
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 Huashan 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heng Yang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860946
- Sponsor's protocol ID
- HS9126
- Status last verified
- May 2023
- First submitted
- 6 May 2023
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang H, Hu Z, Gao X, Su J, Jiang H, Yang S, Zhang Q, Ni W, Gu Y. Safety and efficacy of remote ischemic conditioning in adult moyamoya disease patients undergoing revascularization surgery: a pilot study. Front Neurol. 2023 Jul 28;14:1200534. doi: 10.3389/fneur.2023.1200534. eCollection 2023.
PubMed 37576009
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Remote Ischemic Conditioning in Adult Moyamoya Disease Patients Undergoing Revascularization Surgery
- ClinicalTrials.gov ID
- NCT05860946
- Acronym / sponsor ID
- HS9126
- Conditions
- Moyamoya Disease, Remote Ischemic Conditioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 16 May 2023 (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.
Remote ischemic conditioning (RIC) is a non-invasive therapeutic approach for protecting organs or tissue against the detrimental effects of acute ischemia-reperfusion injury. Many protective factors produced by the stimulus of RIC could protect remote target organs and tissues through inhibiting oxidation and inflammation. The phenomenon of this protect effect was first found in myocardium ischemia-reperfusion injury and then RIC was used in children cardiac surgery to provide myocardial protection during operation. Then RIC was gradually applied to brain protection and a series of clinical researches have confirmed that it could improve the cerebral perfusion status, increase cerebral tolerance to ischemic injury, reduce perihematomal edema and promote clearance. Recently, a randomized controlled study reported that daily RIC could improve cerebral perfusion and slow arterial progression of adult MMD. Meanwhile, a single-arm open-label study also indicated that RIC was a promising noninvasive method for ischemic MMD control by relieving symptoms and reducing stroke recurrence. In addition, the effects of RIC on reducing neurological complications in MMD patients treated with revascularization surgery has also been reported. However, the mechanism of RIC in reducing peri-operative complications for MMD patients is still unknown. Thus, we conducted a randomized controlled study to explore the safety and efficacy of RIC in adult MMD patients undergoing revascularization therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC group | Experimental | Device: Remote ischemic conditioningPatients in RIC group and control group will achieve RIC intervention and sham RIC intervention three times daily from 5 days before operation and 7 days post operation |
| Control group | Sham comparator | Device: Remote ischemic conditioningPatients in control group, bilateral upper arm cuffs were inflated to a pressure of 60 mm Hg for 5 minutes, followed by 5 minutes of relaxation of the cuffs |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged from 18 to 65 years old;
- Subjects all performed digital subtraction angiography (DSA) and diagnosed with MMD accroding to the criteria recommended by the Research Committee on MMD (Spontaneous Occlusion of the Circle of Wills) of the Ministry of Health and Welfare of Japan in 201211.
- Modified Rankin Scale (mRS) score<4;
- Informed consent obtained from the patient or legally authorized representative.
Key exclusion criteria (6 listed)
- Subjects suffered from acute ischemic or hemorrhagic stroke within 3 months;
- Severe hepatic or renal dysfunction;
- Severe cardiac disease;
- Severe hemostatic disorder or severe coagulation dysfunction;
- 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 |
|---|---|---|
| Remote ischemic conditioningThe RIC intervention included five cycles of 5 min inflating tourniquets with the pressure of 200 mmHg and 5 min deflating with pressure of 0 mmHg alternately | Device | Control group, RIC group |
Primary outcome
the incidence of major neurologic complications during perioperative period
Time frame: 2 weeks after operation
1 secondary outcome
The Modified Rankin Scale (MRS) score
Time frame: at 90 days postoperation and at 1 year after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Derived from this study: PubMed 37576009Yang H, Hu Z, Gao X, Su J, Jiang H, Yang S, Zhang Q, Ni W, Gu Y. Safety and efficacy of remote ischemic conditioning in adult moyamoya disease patients undergoing revascularization surgery: a pilot study. Front Neurol. 2023 Jul 28;14:1200534. doi: 10.3389/fneur.2023.1200534. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic conditioning in people with Moyamoya Disease and Remote Ischemic Conditioning, run by Huashan Hospital.
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 6 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 16 May 2023. 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. 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?
the incidence of major neurologic complications during perioperative period (time frame: 2 weeks after operation). 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 NCT05860946, 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 16 May 2023.