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Completed

NCT Number: NCT04012268

The Safety and Efficacy of RIC on Adult Moyamoya Disease

There are a series of symptoms such as ischemic stroke、transient ischemic attack 、hemorrhagic stroke、headache 、seizure and so on in moyamoya disease( MMD) patients .Nowadays, revascularization is the only effective way for ischemic MMD and there is no effective conservative treatment for MMD. This study was to explore the safety and efficacy of remote ischemic conditioning(RIC ) on adult MMD patients.

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Key information

Conditions

Moyamoya Disease Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebral Arterial Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

About this study

There are a series of symptoms such as ischemic stroke、transient ischemic attack 、hemorrhagic stroke、headache 、seizure and so on in moyamoya disease. Nowadays, revascularization is the only effective way for ischemic MMD while controversial for hemorrhagic MMD patients. Surgical complications including hyperperfusion syndrome, cerebral infarction or bleeding often occurred postoperatively. There is no effective conservative treatment for MMD up to now.

Remote ischemic conditioning is Remote ischemic conditioning (RIC) is a noninvasive and easy-to-use neuroprotective strategy, and it has potential effects on preventing ischemia reperfusion injury and ischemic infarction.This study was to explore the safety and efficacy of remote ischemic conditioning on adult MMD patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18-60 years
  • All of the patients underwent digital subtraction angiography (DSA) and met the current diagnostic criteria recommended by the Research Committee on MMD of the Ministry of Health and Welfare of Japan in 2012.
  • mRs≤3
  • Informed consent obtained from patient or acceptable patient's surrogate.

Exclusion criteria

  • Patients with acute ischemic or hemorrhagic stroke within 3 months.
  • Severe hepatic or renal dysfunction.
  • Severe hemostatic disorder or severe coagulation dysfunction.
  • Severe cardiac diseases.
  • Patients with severe existing neurological or psychiatric disease
  • Patients with moyamoya syndrome caused by autoimmune disease, Down syndrome , neurofibromatosis, leptospiral infection, or previous skull-base radiation therapy.
  • Patients have been done or plan to accept revascularization surgery.

Treatment and study plan

RIC

Device

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.

Aspirin

Drug

patients will accept medication guided by neurologists

Primary outcomes

  1. improvement ratio of mean cerebral blood flow

    Time frame: change from the baseline to12 months after treatment

    Cerebral blood flow refers to the flow of blood through a certain cross-sectional area of cerebrovascular in a unit time. Patients' CBF will be detected by arterial spin labeling. In each hemisphere, middle cerebral artery territory was divided into ten regions according to Albert Stroke Program Early CT score (ASPECTS), regions of interest (ROI) were drawn manually in each of territory of MCA to determine the absolute CBF values. improvement ratio of mean CBF= mCBF atter treatment-mCBF baseline/mCBF baseline.

Secondary outcomes

  1. incidence of ischemic stroke

    Time frame: from the baseline to 12 months after treatment

    ischemic stroke is diagnosed by symptoms of neurologic deficit or head CT and MRI.

  2. incidence of transient ischemic attack

    Time frame: from the baseline to 12 months after treatment

    TIA is diagnosed by patients' transient neurologic deficit

  3. incidence of hemorrhagic stroke

    Time frame: from the baseline to 12 months after treatment

    hemorrhagic stroke is diagnosed by head CT

  4. The level of matrix metalloproteinase 9 (MMP-9)

    Time frame: change from the baseline to 3, 6, 12 months after treatment

    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

  5. The level of vascular endothelial growth factor

    Time frame: change from the baseline to 3, 6, 12 months after treatment

    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

  6. The level of basic fibroblast growth factor

    Time frame: change from the baseline to 3, 6 ,12 months after treatment

    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

  7. The rate of death and adverse event

    Time frame: change from the baseline to 12 months after treatment

    All causes of death will be included to compute mortality at 12 months after therapy

  8. The number of patients with erythema,and/or skin lesions related to RIC

    Time frame: change from the baseline to 12 months after treatment

    Professional doctors will check it and the investigator will record the number.

  9. The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure

    Time frame: change from the baseline to 12 months after treatment

    the investigator will record the number.

  10. The rate of progression of stenosis or occlusion at Willis circle

    Time frame: 12 months after therapy

    Progression of stenosis or occlusion at Willis circle was evaluated by TOF-MRA, which was defined as the the stenosis or occlusion was progressed to another part of Willis circle, like stenosis progressed from M1 to M2-M4 et al, or in the same part, stenosis progressed to occlusion.

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

The Safety and Effect of Remote Ischemic Conditioning on Adult Moyamoya Disease

Acronym: RIC-AMD

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jul 9, 2019
Registry last updated
Mar 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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