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Effects of Remote Ischemic Pre-Conditioning in Moyamoya Disease Patients (RIME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064658
Recruitment Status : Suspended (waiting for the ethics approval of collaborator affiliation)
First Posted : August 22, 2019
Last Update Posted : September 19, 2019
Sponsor:
Collaborator:
Peking University International Hospital
Information provided by (Responsible Party):
yuanli Zhao, Beijing Tiantan Hospital

Brief Summary:
In the present study, investigators evaluated whether RIPC reduce the major neurological complications in adult moyamoya disease patients undergoing encephaloduroarteriosynangiosis (EDAS).

Condition or disease Intervention/treatment Phase
Moyamoya Disease Remote Ischemic Preconditioning Procedure: Remote ischemic preconditioning Procedure: Sham remote ischemic preconditioning Procedure: Encephaloduroarteriosynangiosis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 328 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Remote Ischemic Pre-Conditioning on Neurologic Complications in Adult Ischemic Moyamoya Disease Patients Undergoing Encephaloduroarteriosynangiosis
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : April 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Sham RIPC group

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

Procedure: Sham remote ischemic preconditioning
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.
Other Name: Sham RIPC

Procedure: Encephaloduroarteriosynangiosis
Encephaloduroarteriosynangiosis is an indirect revascularization surgery of moyamoya disease
Other Name: EDAS

Experimental: RIPC group

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

Procedure: Remote ischemic preconditioning
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.
Other Name: RIPC

Procedure: Encephaloduroarteriosynangiosis
Encephaloduroarteriosynangiosis is an indirect revascularization surgery of moyamoya disease
Other Name: EDAS




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. The Severity of the Ischemic Stroke after Surgery [ Time Frame: postoperative one month ]
    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.

  2. Number of Patients Occured Re-stroke at Follow-up Period [ Time Frame: 6 months and 12 months after EDAS ]
    Re-stroke included ischemic stroke and hemorrhagic stroke.

  3. Number of Patients Dependent or Death at Follow-up Period [ Time Frame: 6 months and 12 months after EDAS ]
    Dependent included the modified Rankin Scale (mRS) > 2. Death included any reason caused death.

  4. Number of Patients with Improved Neurological Function at Follow-up Period [ Time Frame: 6 months and 12 months after EDAS ]
    The modified Rankin Scale (mRS) decreased at the follow-up period compared to preoperative scores

  5. Perfusion Status of Patients at Follow-up Period [ Time Frame: 6 months and 12 months after EDAS ]
    The perfusion status detected by stages of pre-infarction period based on computed tomography perfusion imaging

  6. Number of Patients With Any Side Effects of Remote Ischemic Preconditioning (RIPC) Treatment. [ Time Frame: From baseline to 12 months after treatment ]
    The side effects referred to any side effects of RIPC or sham RIPC treatment, not including the sides effect of medications and EDAS.

  7. Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans. [ Time Frame: Within 48 hours after EDAS ]
    The presence of ≥1 new brain lesions on DWI



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who diagnosed with moyamoya disease
  2. Adults 18 to 65 years of age
  3. The onset symptoms manifested as ischemic symptoms (TIA or stroke) or atypical symptoms (headache, epilepsy or asymptomatic)
  4. Able to receive the necessary imaging examination
  5. Patients who pre-agreed to the study

Exclusion Criteria:

  1. Prior cerebral hemorrhage history
  2. Other brain or cerebrovascular disease
  3. Previous history of revascularization surgery
  4. Dependent (mRS > 2)
  5. Receive other type of revascularization surgery
  6. Peripheral blood vessel disease (especially subclavian arterial and upper limb artery stenosis or occlusion).
  7. Patients who do not agree with the study

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): NCT04064658


Locations
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China, Beijing
Beijing Tiantan Hosiptal
Beijing, Beijing, China, 100070
Peking University International Hospital
Beijing, Beijing, China, 102206
Sponsors and Collaborators
Beijing Tiantan Hospital
Peking University International Hospital
Investigators
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Principal Investigator: Yuanli Zhao, MD Beijing Tiantan Hospital
Principal Investigator: Rong Wang, MD Beijing Tiantan Hospital
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Responsible Party: yuanli Zhao, Professor, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT04064658    
Other Study ID Numbers: RIPC2019
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The individual participant data (IPD) of this study are available from the principal investigator upon reasonable request.
Supporting Materials: Study Protocol
Time Frame: 6 months after the study ended
Access Criteria: The IPD of this study are available from the principal investigator upon reasonable request.

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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 yuanli Zhao, Beijing Tiantan Hospital:
Moyamoya Disease
Cerebrovascular Disorders
Arterial Occlusive Diseases
Ischemia
Additional relevant MeSH terms:
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Moyamoya Disease
Ischemia
Pathologic Processes
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases