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Effects of Remote Ischemic Conditioning on Dynamic Cerebral Autoregulation, Blood Pressure and Heart Rate Variability in Patients With Cerebral Small Vessel Disease (ESCAPE-SVD)

Primary Purpose

Cerebral Small Vessel Diseases

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Remote ischemic conditioning
Sham remote ischemic conditioning
Sponsored by
Yi Yang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Small Vessel Diseases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1) Regardless of age, sex;
  • 2) Patients are diagnosed with cerebral small vessel disease, and neuroimaging shows new subcortical lacunar infarction (in line with one of the following):

    ① MRI examination Diffusion-weighted imaging (DWI) phase shows high signal intensity [Apparent Diffusion Coefficient (ADC) diffusion restriction] lesions < 20 mm diameter in subcortical, basal ganglia or brainstem , with or without corresponding clinical symptoms;

    ② With new clinical symptoms, MRI examination FLAIR sequence shows corresponding FLAIR high signal intensity lesions [diameter < 20 mm]) in subcortical, basal ganglia or pons;

  • 3) Remote ischemic conditioning can be started within 7 days from onset;
  • 4) Willing to participate and sign the informed consent.

Exclusion Criteria:

  • 1) Vascular stenosis > 50% by Transcranial Doppler (TCD);
  • 2) Previous history of intracranial hemorrhage or major bleeding in other parts of the body;
  • 3) Previous history of atrial fibrillation or myocardial infarction within 6 months;
  • 4) Moyamoya disease or hereditary cerebral small vessel disease, such as mitochondrial encephalopathy, CADASIL or Fabry;
  • 5) The patients who had clear non-vascular white matter lesions, such as multiple sclerosis, adult white matter dysplasia, metabolic encephalopathy;
  • 6) Severe hepatic and renal diseases, cancer or other major diseases related to medical and surgical procedures;
  • 7) The patients who had the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb; Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc;
  • 8) Significant coagulation abnormalities;
  • 9) Pregnant or lactating women;
  • 10) The patients with disturbance of consciousness or agitation who cannot cooperate to dynamic cerebral autoregulation monitoring or beat-to-beat blood pressure monitoring;
  • 11) Previous remote ischemic conditioning therapy or similar treatment;
  • 12) Unwilling to be followed up or treated for poor compliance;
  • 13) He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission;
  • 14) Other conditions that the researchers think are not suitable for the group.

Sites / Locations

  • The First Hospital of Jilin UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

RIC+Standard medical treatment

Sham RIC+Standard medical treatment

Arm Description

Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mmHg. RIC will be conducted twice daily during the period of hospitalization. Besides, the patients will be treated with standard medical treatment according to consensus on diagnosis and treatment of cerebral small vessel disease in China 2015, including antiplatelet aggregation and lipid-stabilizing drugs as well as neurotrophic and circulation improving treatment.

Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 60 mmHg. RIC will be conducted twice daily during the period of hospitalization. Besides, the patients will be treated with standard medical treatment according to consensus on diagnosis and treatment of cerebral small vessel disease in China 2015, including antiplatelet aggregation and lipid-stabilizing drugs as well as neurotrophic and circulation improving treatment.

Outcomes

Primary Outcome Measures

Phase Difference(PD) in Degree
PD is a dynamic cerebral auto-regulation parameter derived from transfer function analysis.
Differences of blood pressure variability (BPV) in Degree after in-hospital remote ischemic conditioning finished between two groups
BPV is defined as blood pressure oscillations in relation to the mean values.
Differences of heart rate variability (HRV) in Degree after in-hospital remote ischemic conditioning finished between two groups
HRV is defined as heart rate oscillations in relation to the mean values.

Secondary Outcome Measures

Differences of BPV in Degree after 3-4 days remote ischemic conditioning treatment between two groups
BPV is defined as blood pressure oscillations in relation to the mean values.
Differences of HRV in Degree after 3-4 days remote ischemic conditioning treatment between two groups
HRV is defined as heart rate oscillations in relation to the mean values.
PD in Degree
PD is a dynamic cerebral auto-regulation parameter derived from transfer function analysis.
Differences in modified Rankin Scale (mRS) Score between two groups
Modified Rankin Scale (mRS) Score ranged from 0 to 6, a low value represents a better outcome.

Full Information

First Posted
December 9, 2021
Last Updated
February 20, 2023
Sponsor
Yi Yang
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1. Study Identification

Unique Protocol Identification Number
NCT05225948
Brief Title
Effects of Remote Ischemic Conditioning on Dynamic Cerebral Autoregulation, Blood Pressure and Heart Rate Variability in Patients With Cerebral Small Vessel Disease
Acronym
ESCAPE-SVD
Official Title
Effects of Remote Ischemic Conditioning on Dynamic Cerebral Autoregulation, Blood Pressure and Heart Rate Variability in Patients With Cerebral Small Vessel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 30, 2021 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yi Yang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine effects of remote ischemic conditioning on dynamic cerebral autoregulation, blood pressure and heart rate variability in patients with cerebral small vessel disease.
Detailed Description
In this study, 100 cases of cerebral small vessel disease in the First Hospital of Jilin University are divided into 2 groups according to the intention of the individual. On the basis of standard medical treatment, the experimental group receive in-hospital remote ischemic conditioning treatment for 200 mmHg, 2 times per day; the control group receive remote ischemic conditioning for 60 mmHg, 2 times per day during the period of hospitalization. Patients in both groups undergo several dynamic cerebral autoregulation and beat-to-beat monitoring respectively at baseline, 3-4 days of remote ischemic conditioning and the time the last in-hospital remote ischemic conditioning performed. Two groups will be followed up for 90 days to evaluate the effects of remote ischemic conditioning therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Small Vessel Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RIC+Standard medical treatment
Arm Type
Active Comparator
Arm Description
Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mmHg. RIC will be conducted twice daily during the period of hospitalization. Besides, the patients will be treated with standard medical treatment according to consensus on diagnosis and treatment of cerebral small vessel disease in China 2015, including antiplatelet aggregation and lipid-stabilizing drugs as well as neurotrophic and circulation improving treatment.
Arm Title
Sham RIC+Standard medical treatment
Arm Type
Placebo Comparator
Arm Description
Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 60 mmHg. RIC will be conducted twice daily during the period of hospitalization. Besides, the patients will be treated with standard medical treatment according to consensus on diagnosis and treatment of cerebral small vessel disease in China 2015, including antiplatelet aggregation and lipid-stabilizing drugs as well as neurotrophic and circulation improving treatment.
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic conditioning
Intervention Description
Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mmHg. RIC will be conducted twice daily during the period of hospitalization.
Intervention Type
Procedure
Intervention Name(s)
Sham remote ischemic conditioning
Intervention Description
Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 60 mmHg. RIC will be conducted twice daily during the period of hospitalization.
Primary Outcome Measure Information:
Title
Phase Difference(PD) in Degree
Description
PD is a dynamic cerebral auto-regulation parameter derived from transfer function analysis.
Time Frame
within 7 days of RIC
Title
Differences of blood pressure variability (BPV) in Degree after in-hospital remote ischemic conditioning finished between two groups
Description
BPV is defined as blood pressure oscillations in relation to the mean values.
Time Frame
within 7 days of RIC
Title
Differences of heart rate variability (HRV) in Degree after in-hospital remote ischemic conditioning finished between two groups
Description
HRV is defined as heart rate oscillations in relation to the mean values.
Time Frame
within 7 days of RIC
Secondary Outcome Measure Information:
Title
Differences of BPV in Degree after 3-4 days remote ischemic conditioning treatment between two groups
Description
BPV is defined as blood pressure oscillations in relation to the mean values.
Time Frame
3-4 days after RIC
Title
Differences of HRV in Degree after 3-4 days remote ischemic conditioning treatment between two groups
Description
HRV is defined as heart rate oscillations in relation to the mean values.
Time Frame
3-4 days after RIC
Title
PD in Degree
Description
PD is a dynamic cerebral auto-regulation parameter derived from transfer function analysis.
Time Frame
3-4 days after RIC
Title
Differences in modified Rankin Scale (mRS) Score between two groups
Description
Modified Rankin Scale (mRS) Score ranged from 0 to 6, a low value represents a better outcome.
Time Frame
3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) Regardless of age, sex; 2) Patients are diagnosed with cerebral small vessel disease, and neuroimaging shows new subcortical lacunar infarction (in line with one of the following): ① MRI examination Diffusion-weighted imaging (DWI) phase shows high signal intensity [Apparent Diffusion Coefficient (ADC) diffusion restriction] lesions < 20 mm diameter in subcortical, basal ganglia or brainstem , with or without corresponding clinical symptoms; ② With new clinical symptoms, MRI examination FLAIR sequence shows corresponding FLAIR high signal intensity lesions [diameter < 20 mm]) in subcortical, basal ganglia or pons; 3) Remote ischemic conditioning can be started within 7 days from onset; 4) Willing to participate and sign the informed consent. Exclusion Criteria: 1) Vascular stenosis > 50% by Transcranial Doppler (TCD); 2) Previous history of intracranial hemorrhage or major bleeding in other parts of the body; 3) Previous history of atrial fibrillation or myocardial infarction within 6 months; 4) Moyamoya disease or hereditary cerebral small vessel disease, such as mitochondrial encephalopathy, CADASIL or Fabry; 5) The patients who had clear non-vascular white matter lesions, such as multiple sclerosis, adult white matter dysplasia, metabolic encephalopathy; 6) Severe hepatic and renal diseases, cancer or other major diseases related to medical and surgical procedures; 7) The patients who had the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb; Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc; 8) Significant coagulation abnormalities; 9) Pregnant or lactating women; 10) The patients with disturbance of consciousness or agitation who cannot cooperate to dynamic cerebral autoregulation monitoring or beat-to-beat blood pressure monitoring; 11) Previous remote ischemic conditioning therapy or similar treatment; 12) Unwilling to be followed up or treated for poor compliance; 13) He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission; 14) Other conditions that the researchers think are not suitable for the group.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Yang, MD, PhD
Phone
0086-13756661217
Email
doctor_yangyi@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen-Ni Guo, MD
Email
zhen1ni2@163.com
Facility Information:
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Yang, MD, PhD
Email
doctor_yangyi@163.com

12. IPD Sharing Statement

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Effects of Remote Ischemic Conditioning on Dynamic Cerebral Autoregulation, Blood Pressure and Heart Rate Variability in Patients With Cerebral Small Vessel Disease

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