Safety and Efficacy of Remote Ischemic Conditioning Combined EDAS on Ischemic Moyamoya Disease

Last updated: June 27, 2021
Sponsor: Capital Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Moyamoya Syndrome

Occlusions

Treatment

N/A

Clinical Study ID

NCT04917003
RIC-IMD
  • Ages 18-65
  • All Genders

Study Summary

Encephaloduroarteriosynangiosis (EDAS) is widely used as an indirect technique for treatment of moyamoya disease. Nevertheless, this indirect surgery tends to establish insufficient collateral circulation in most adult MMD patients. Nowadays, there is a lack of adjuvant therapies for improving collateral circulation induced by indirect revascularization. This study aims to explore whether remote ischemic conditioning can improve the collateral circulation after indirect revascularization.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects who were diagnosed as moyamoya disease by the diagnostic criteria recommendedby the Research Committee on MMD of the Ministry of Health and Welfare of Japan in
  3. Suzuki stage: 2-5 stage
  4. Age: between 18 and 65 years old
  5. Subjects present with ischemic stroke or transient ischemic attack.
  6. Subjects who plan to accept the first EDAS surgery.
  7. Informed consent obtained from patient or patient's surrogate

Exclusion

Exclusion Criteria:

  1. Acute ischemic stroke occurred within one month.
  2. Suffered Intracranial hemorrhage before
  3. Subjects with large infarction spread widely over the territory of a main arterialtrunk
  4. Aneurysms in the main arterial trunk
  5. Severe cardiac diseases like atrial fibrillation，valvular disease，heart failure,infective endocarditis and so on.
  6. Malignant tumors or severe disordered function of the heart, lung, liver or kidney.
  7. Severe hemostatic disorder or severe coagulation dysfunction.
  8. Uncontrolled diabetes mellitus with a serum fasting blood glucose level>300 mg/dL, orrequires insulin; hypertension with a systolic blood pressure over 180 mmHg or adiastolic blood pressure over 110 mmHg.
  9. Severe injury on upper limbs.
  10. Pregnant or lactating women.
  11. Life expectancy is less than 3 years.
  12. Patients who are not suitable for this trial considered by researchers for otherreasons

Study Design

Total Participants: 60
Study Start date:
June 15, 2021
Estimated Completion Date:
June 30, 2022

Study Description

Encephaloduroarteriosynangiosis (EDAS) is widely used as an indirect technique for treatment of moyamoya disease. Nevertheless, this indirect surgery tends to establish insufficient collateral circulation in most adult MMD patients. Nowadays, there is a lack of adjuvant therapies for improving collateral circulation induced by indirect revascularization. Remote ischemic conditioning (RIC) is a noninvasive approach protecting the brain by inflating and deflating blood-pressure cuff placed on the upper limbs. It has been confirmed to improve cerebral perfusion by promoting angiogenesis and arteriogenesis in ischemic animal brain. In addition, daily remote ischemic conditioning is a promising technique to ameliorate chronic cerebrovascular disease like intracranial atherosclerotic stenosis, small-vessel disease.

Thus, this study aims to explore whether remote ischemic conditioning can improve the collateral circulation after indirect revascularization.

Connect with a study center

  • The 307th Hospital of the Chinese People's Liberation Army

    Beijing, 100071
    China

    Active - Recruiting

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