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Clinical Trial on Remote Ischemic Preconditioning and Cerebral Small Vessel Disease (RIPC-SVD)

Primary Purpose

Cerebral Small Vessel Disease

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

remote ischemic preconditioning

sham remote ischemic preconditioning

About this trial

This is an interventional treatment trial for Cerebral Small Vessel Disease focused on measuring remote ischemic preconditioning, random-controlled, double blind, RIPC

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Xuan Wu Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

remote ischemic preconditioning

placebo remote ischemic preconditioning

Arm Description

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

Receiving sham RIPC treatment with pressure set at 50 mmHg

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in the cognitive function

Cognitive function will be evaluated by mini-mental state examination (MMSE) and the Montreal Cognitive Assessment (MoCA).

Changes in the cerebral blood perfusion

Cerebral blood perfusion will be evaluated by Xe-CT.

Full Information

NCT ID

NCT01658306

First Posted

July 26, 2012

Last Updated

November 25, 2014

Sponsor

Capital Medical University

Collaborators

Peking University First Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01658306

Brief Title

Clinical Trial on Remote Ischemic Preconditioning and Cerebral Small Vessel Disease

Acronym

RIPC-SVD

Official Title

A Random Controlled, Double-Blind Clinical Trial: Remote Ischemic Preconditioning and Cerebral Small Vessel Disease

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Capital Medical University

Collaborators

Peking University First Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed Description

CSV constitutes an important type of ischemic stroke due to a generalized hypo-perfusion of brain. Few treatment methods are available except some beneficial effect shown with nimodipine. The potential treatment effect of RIPC on protection of brain from cerebral small vessel disease has not been investigated. The investigators designed this randomized, double-blind, controlled clinical trial to examine (1) whether RIPC has a beneficial effect on brain lesions of CSV, and (2) whether RIPC can protect patients of CSV from cognitive deterioration. There are 2 arms in this trial: One arm is RIPC treatment, the other one is sham RIPC treatment. Brain lesions will be quantified by volumetric MRI, and Xe-CT will be used to evaluate cerebral blood perfusion. Cognitive function will be evaluated by mini-mental state examination (MMSE) and the Montreal Cognitive Assessment (MoCA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Small Vessel Disease

Keywords

remote ischemic preconditioning, random-controlled, double blind, RIPC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

remote ischemic preconditioning

Arm Type

Experimental

Arm Description

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

Arm Title

placebo remote ischemic preconditioning

Arm Type

Sham Comparator

Arm Description

Receiving sham RIPC treatment with pressure set at 50 mmHg

Intervention Type

Procedure

Intervention Name(s)

remote ischemic preconditioning

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

sham remote ischemic preconditioning

Intervention Description

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.

Primary Outcome Measure Information:

Title

changes in brain lesions

Description

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

Time Frame

0-24 months

Secondary Outcome Measure Information:

Title

Changes in the cognitive function

Description

Cognitive function will be evaluated by mini-mental state examination (MMSE) and the Montreal Cognitive Assessment (MoCA).

Time Frame

0-24 months

Title

Changes in the cerebral blood perfusion

Description

Cerebral blood perfusion will be evaluated by Xe-CT.

Time Frame

0-24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xunming Ji, M.D., Ph.D.

Organizational Affiliation

Xuan Wu Hospital of Capital Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xuan Wu Hospital

City

Beijing

ZIP/Postal Code

100053

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

29042490

Citation

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.

Results Reference

derived

PubMed Identifier

27351719

Citation

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.

Results Reference

derived

Learn more about this trial

Clinical Trial on Remote Ischemic Preconditioning and Cerebral Small Vessel Disease

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