NCT01658306

Brief Summary

The hypothesis of this study is that remote ischemic preconditioning (RIPC) might have a beneficial effect on outcomes of cerebral small vessel disease (CSV).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

November 26, 2014

Status Verified

November 1, 2014

Enrollment Period

1.9 years

First QC Date

July 26, 2012

Last Update Submit

November 25, 2014

Conditions

Cerebral Small Vessel Disease

Keywords

remote ischemic preconditioningrandom-controlleddouble blindRIPC

Outcome Measures

Primary Outcomes (1)

  • changes in brain lesions

    Volumetric MRI will be used for calculating changes in the number of lacunar infarctions and the total volume of white matter lesions

    0-24 months

Secondary Outcomes (2)

  • Changes in the cognitive function

    0-24 months

  • Changes in the cerebral blood perfusion

    0-24 months

Study Arms (2)

remote ischemic preconditioning

EXPERIMENTAL

Receiving remote ischemic preconditioning (RIPC) treatment with pressure set at 200 mmHg.

Procedure: remote ischemic preconditioning

placebo remote ischemic preconditioning

SHAM COMPARATOR

Receiving sham RIPC treatment with pressure set at 50 mmHg

Procedure: sham remote ischemic preconditioning

Interventions

remote ischemic preconditioningPROCEDURE

RIPC consists of five 5-min cycles of right upper arm ischemia/reperfusion, induced by an automated cuff-inflator placed on the right upper arm which is inflated to 200 mmHg for 5mins followed by deflating the cuff for 5mins, each patient in the RIPC group will have the treatment twice a day for two weeks.

remote ischemic preconditioning
sham remote ischemic preconditioningPROCEDURE

Sham RIPC consists of five 5-min cycles of right upper arm ischemia/reperfusion, induced by an automated cuff-inflator placed on the right upper arm which is inflated to 50 mmHg for 5mins followed by deflating the cuff for 5mins, each patient in the placebo RIPC group will have the treatment twice a day for two weeks.

placebo remote ischemic preconditioning

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects aged 40-80 years;
  • Ischemic cerebrovascular event onset, if any, must be within 6 months;
  • TCD and carotid ultrasound exclude vascular narrow that can cause hemodynamic changes (usually \>50% narrow lumen);
  • MRI confirmed the presence of lacunar infarction and / or generalized white matter lesions;
  • Written consent was obtained from the subject.

You may not qualify if:

  • History of intracranial hemorrhage;
  • Significant bleeding from other parts of the body;
  • History of atrial fibrillation;
  • History of myocardial infarction within six months;
  • Moyamoya disease or vasculitis;
  • Hereditary small vessel disorders, such as CADASIL, FABRY, and mitochondrial encephalo-myopathy;
  • Significant bleeding-coagulation dysfunction;
  • Abnormal blood pressure, glucose and/or lipids after restrict treatment regimen;
  • Severe liver/kidney disease, cancer or critical illness of internal medicine and surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuan Wu Hospital

Beijing, 100053, China

Location

Related Publications (2)

  • Wang Y, Meng R, Song H, Liu G, Hua Y, Cui D, Zheng L, Feng W, Liebeskind DS, Fisher M, Ji X. Remote Ischemic Conditioning May Improve Outcomes of Patients With Cerebral Small-Vessel Disease. Stroke. 2017 Nov;48(11):3064-3072. doi: 10.1161/STROKEAHA.117.017691. Epub 2017 Oct 17.

    PMID: 29042490DERIVED

  • Mi T, Yu F, Ji X, Sun Y, Qu D. The Interventional Effect of Remote Ischemic Preconditioning on Cerebral Small Vessel Disease: A Pilot Randomized Clinical Trial. Eur Neurol. 2016;76(1-2):28-34. doi: 10.1159/000447536. Epub 2016 Jun 29.

    PMID: 27351719DERIVED

MeSH Terms

Conditions

Cerebral Small Vessel Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Xunming Ji, M.D., Ph.D.

    Xuan Wu Hospital of Capital Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurosurgery, Vice-President of Xuan Wu Hospital, Capital Medical University

Study Record Dates

First Submitted

July 26, 2012

First Posted

August 7, 2012

Study Start

July 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

November 26, 2014

Record last verified: 2014-11

Locations

CN(1)