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

NCT05225948 | Recruiting DMC

• 1 other identifier: ESCAPE-SVD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Small Vessel Diseases

Outcome Measures

Primary Outcomes (3)

• Phase Difference(PD) in Degree

  PD is a dynamic cerebral auto-regulation parameter derived from transfer function analysis.

  within 7 days of RIC

• 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.

  within 7 days of RIC

• 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.

  within 7 days of RIC

Secondary Outcomes (4)

• Differences of BPV in Degree after 3-4 days remote ischemic conditioning treatment between two groups

  3-4 days after RIC

• Differences of HRV in Degree after 3-4 days remote ischemic conditioning treatment between two groups

  3-4 days after RIC

• PD in Degree

  3-4 days after RIC

• Differences in modified Rankin Scale (mRS) Score between two groups

  3 months

Study Arms (2)

RIC+Standard medical treatment

ACTIVE COMPARATOR

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.

Procedure: Remote ischemic conditioning

Sham RIC+Standard medical treatment

PLACEBO COMPARATOR

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.

Procedure: Sham remote ischemic conditioning

Interventions

Remote ischemic conditioning PROCEDURE

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.

RIC+Standard medical treatment

Sham remote ischemic conditioning PROCEDURE

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.

Sham RIC+Standard medical treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Regardless of age, sex;
• \) 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;
• \) Remote ischemic conditioning can be started within 7 days from onset;
• \) Willing to participate and sign the informed consent.

You may not qualify if:

• \) Vascular stenosis \> 50% by Transcranial Doppler (TCD);
• \) Previous history of intracranial hemorrhage or major bleeding in other parts of the body;
• \) Previous history of atrial fibrillation or myocardial infarction within 6 months;
• \) Moyamoya disease or hereditary cerebral small vessel disease, such as mitochondrial encephalopathy, CADASIL or Fabry;
• \) The patients who had clear non-vascular white matter lesions, such as multiple sclerosis, adult white matter dysplasia, metabolic encephalopathy;
• \) Severe hepatic and renal diseases, cancer or other major diseases related to medical and surgical procedures;
• \) 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;
• \) Significant coagulation abnormalities;
• \) Pregnant or lactating women;
• \) The patients with disturbance of consciousness or agitation who cannot cooperate to dynamic cerebral autoregulation monitoring or beat-to-beat blood pressure monitoring;
• \) Previous remote ischemic conditioning therapy or similar treatment;
• \) Unwilling to be followed up or treated for poor compliance;
• \) 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;
• \) Other conditions that the researchers think are not suitable for the group.

Sponsors & Collaborators

• Yi Yang: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

MeSH Terms

Conditions

Cerebral Small Vessel Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Yi Yang, MD, PhD

CONTACT

0086-13756661217; doctor_yangyi@163.com

Zhen-Ni Guo, MD

CONTACT

zhen1ni2@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated Dean of First Hospital of Jilin University

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: February 7, 2022
• Study Start: December 30, 2021
• Primary Completion: July 1, 2025
• Study Completion: October 31, 2025
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

CN (1)