NCT04064658

Brief Summary

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

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
328

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

September 19, 2019

Status Verified

July 1, 2019

Enrollment Period

4 years

First QC Date

August 20, 2019

Last Update Submit

September 17, 2019

Conditions

Moyamoya DiseaseRemote Ischemic Preconditioning

Keywords

Moyamoya DiseaseCerebrovascular DisordersArterial Occlusive DiseasesIschemia

Outcome Measures

Primary Outcomes (2)

  • Number of Patients With Cerebrovascular Events.

    Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and hyperperfusion syndrome.

    postoperative one month

  • Number of Patients Dependent or Death

    Dependent included the modified Rankin Scale (mRS) \> 2. Death included any reason caused death.

    postoperative one month

Secondary Outcomes (7)

  • The Severity of the Ischemic Stroke after Surgery

    postoperative one month

  • Number of Patients Occured Re-stroke at Follow-up Period

    6 months and 12 months after EDAS

  • Number of Patients Dependent or Death at Follow-up Period

    6 months and 12 months after EDAS

  • Number of Patients with Improved Neurological Function at Follow-up Period

    6 months and 12 months after EDAS

  • Perfusion Status of Patients at Follow-up Period

    6 months and 12 months after EDAS

  • +2 more secondary outcomes

Study Arms (2)

Sham RIPC group

SHAM COMPARATOR

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 preconditioningProcedure: Encephaloduroarteriosynangiosis

RIPC group

EXPERIMENTAL

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 preconditioningProcedure: Encephaloduroarteriosynangiosis

Interventions

Remote ischemic preconditioningPROCEDURE

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.

Also known as: RIPC
RIPC group
Sham remote ischemic preconditioningPROCEDURE

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.

Also known as: Sham RIPC
Sham RIPC group
EncephaloduroarteriosynangiosisPROCEDURE

Encephaloduroarteriosynangiosis is an indirect revascularization surgery of moyamoya disease

Also known as: EDAS
RIPC groupSham RIPC group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Tiantan Hosiptal

Beijing, Beijing Municipality, 100070, China

Location

Peking University International Hospital

Beijing, Beijing Municipality, 102206, China

Location

Related Publications (1)

  • Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.

    PMID: 36645250DERIVED

MeSH Terms

Conditions

Moyamoya DiseaseCerebrovascular DisordersArterial Occlusive DiseasesIschemia

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebral Arterial DiseasesIntracranial Arterial DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yuanli Zhao, MD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

  • Rong Wang, MD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 20, 2019

First Posted

August 22, 2019

Study Start

October 1, 2019

Primary Completion

October 1, 2023

Study Completion

April 1, 2024

Last Updated

September 19, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share

The individual participant data (IPD) of this study are available from the principal investigator upon reasonable request.

Shared Documents
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.

Locations

CN(2)