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Trial record 88 of 113 for:    Recruiting, Not yet recruiting, Available Studies | Common carotid artery

The Safety and Efficacy of RIC on Adult Moyamoya Disease (RIC-AMD)

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ClinicalTrials.gov Identifier: NCT04012268
Recruitment Status : Not yet recruiting
First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Ji Xunming,MD,PhD, Capital Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Moyamoya Disease Device: RIC Device: sham-RIC Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Safety and Effect of Remote Ischemic Conditioning on Adult Moyamoya Disease
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : August 8, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RIC group
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.
Device: RIC
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 Comparator: sham-RIC group
Patients with AIS complicating ACS who were eligible for this study received standardized medical treatment and secondary prevention, including antiplatelets, low molecular weight heparin for anticoagulation,statins for lipid-lowering and stabilizing plaque, nitrates for vascular expansion and cardiocerebrovascular risk factors management. Administration of antihypertensive, antidiabetic or other agents were elective at the discretion of the treating physician according to the conditions of the patients. In addition, patients underwent sham-RIC twice daily for 14 days.And the sham-RIC procedure during which bilateral arm cuffs are inflated to a pressure of 60mmHg for five cycles of 5 min followed by 5 min of relaxation of the cuffs.
Device: sham-RIC
The sham-RIC procedure during which bilateral arm cuffs are inflated to a pressure of 60mmHg for five cycles of 5 min followed by 5 min of relaxation of the cuffs.




Primary Outcome Measures :
  1. 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

  2. perfusion status [ Time Frame: change from the baseline to 12 months after treatment ]
    perfusion status detected by Single-Photon Emission Computed Tomography


Secondary Outcome Measures :
  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. wall area [ Time Frame: change from the baseline to 6, 12 months after treatment ]
    wall area is detected by 3T high-resolution black blood vessel wall imaging

  5. remodeling index [ Time Frame: change from the baseline to 6, 12 months after treatment ]
    The ratio of vessel wall at maximal lumen narrowing to reference vessel. and the vessel wall is detected by 3T high-resolution black blood vessel wall

  6. the degree of enhancement of vessel wall [ Time Frame: change from the baseline to 6, 12 months after treatment ]
    grade 0, no enhancement; grade 1, mild enhancement, the signal intensity of vessel wall is less than that of the pituitary infundibulum ; and grade 2, strong enhancement, the signal intensity of contrast enhanced vessel wall is similar to or greater than that of the infundibulum. it was detected by 3T high-resolution black blood vessel wall

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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.

  12. 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 ]
    he investigator will record the number.

  13. the total length of lenticulostriate arteries [ Time Frame: change from the baseline to 6, 12 months after treatment ]
    the total length of lenticulostriate arteries is detected by 3T high-resolution black blood vessel wall imaging

  14. average length of lenticulostriate arteries [ Time Frame: change from the baseline to 6, 12 months after treatment ]
    average length of lenticulostriate arteries is detected by 3T high-resolution black blood vessel wall imaging

  15. the number of lenticulostriate arteries [ Time Frame: change from the baseline to 6, 12 months after treatment ]
    the number of lenticulostriate arteries is detected by 3T high-resolution black blood vessel wall imaging



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04012268


Contacts
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Contact: Xunming Ji, MD PhD 108613911077166 Jixunming@vip.163.com
Contact: Sijie Li, MD 1083199439 phoenix0537@sina.com

Locations
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China, Beijing
Xuanwu Hospital, Capital Medical University
Beijing, Beijing, China, 100053
Sponsors and Collaborators
Capital Medical University

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Responsible Party: Ji Xunming,MD,PhD, Professor, Capital Medical University
ClinicalTrials.gov Identifier: NCT04012268     History of Changes
Other Study ID Numbers: RIC-AMD
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ji Xunming,MD,PhD, Capital Medical University:
moyamoya disease
remote ischemic conditioning
cerebral blood flow
Additional relevant MeSH terms:
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Carotid Artery Diseases
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Arterial Occlusive Diseases
Moyamoya Disease
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases