Remote Ischemic Conditioning and Dynamic Cerebral Autoregulation in Patients With Intracranial and Extracranial Arteriosclerosis

The purpose of this study is to explore the effect of remote ischemic conditioning on the dynamic cerebral autoregulation in patients with intracranial and extracranial arteriosclerosis and the changes of dynamic cerebral autoregulation within 24 hours after remote ischemic conditioning.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke; Carotid Stenosis
• Intervention / Treatment: Procedure: remote ischemic conditioning; Procedure: sham remote ischemic conditioning

Detailed Description

In this study, patients with intracranial and extracranial arteriosclerosis were included. The experimental group received basic treatment and remote ischemic conditioning for 200mmHg to pressurize the upper arm of the healthy side for 5 minutes, relax for 5 minutes, and repeat 4 cycles. The control group received basic treatment and remote ischemic conditioning for 60mmHg to pressurize the upper arm of the healthy side for 5 minutes, relax for 5 minutes, and repeat 4 cycles. The dynamic cerebral autoregulation was measured before treatment, immediately after treatment, 6 hours after treatment and 24 hours after treatment in both groups. The investigators aimed to determine the effect of remote ischemic conditioning on the dynamic cerebral autoregulation in patients with intracranial and extracranial arteriosclerosis. The investigators hypothesized that remote ischemic conditioning would improve dynamic cerebral autoregulation in patients with intracranial and extracranial arteriosclerosis.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • Recruiting
      • First Hospital of Jilin University
      • Contact: Zhenni Guo; Phone Number: 043188782080; Email: zhen1ni2@163.com
    • Changchun, Jilin, China, 130000
      • Not yet recruiting
      • First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age≥18 years, < 80 years, regardless of sex;
2. Patients with clinically definite diagnosis of intracranial and extracranial atherosclerosis.
3. Baseline Glasgow Coma Scale (GCS) ≥8;
4. Be able to accept remote ischemic conditioning;
5. Bilateral temporal windows were well penetrated;
6. Signed and dated informed consent is obtained

Exclusion Criteria:

1. Patients who undergo intravenous thrombolysis or endovascular treatment;
2. Patients with consciousness disorder or restlessness who cannot cooperate with dynamic cerebral autoregulation;
3. Patients whose stable cerebral blood flow velocity envelope cannot be obtained by transcranial Doppler ultrasound or whose cerebral blood vessels have not been detected;
4. Patients with severe arrhythmia (frequent ventricular or supraventricular arrhythmia diagnosed by 24 hours dynamic ECG), hyperthyroidism, severe anemia, unstable blood pressure and other factors affecting the hemodynamics;
5. CT shows cerebral hemorrhagic diseases: hemorrhagic stroke, epidural hematoma, subdural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc;
6. Other intracranial lesions, such as cerebrovascular malformations, cerebral venous lesions, tumors and other diseases involving the brain craniocerebral planning for surgical treatment;
7. Other serious diseases and have a life expectancy of less than 3 months;
8. Serious blood system diseases or severe coagulation dysfunction;
9. Severe organ dysfunction or failure;
10. Previously received remote ischemic conditioning or similar treatment;
11. Contraindications of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury, peripheral vascular disease in the contralateral upper limb;
12. Unqualified laboratory test indicators: Aspartate aminotransferase or alanine aminotransferase was 3 times higher than the upper limit of normal range, serum creatinine was > 265umol/l (> 3mg/dl), platelet was < 100×109/ l, international normalized ratio (INR), activated partial thromboplastin time (APTT), prothrombin time (PT) were above the upper limit of normal range;
13. Pregnant or lactating women;
14. Participating in other clinical investigators, or having participated in other clinical investigators within 3 months before enrollment;
15. Patients who do not follow up or have poor treatment compliance;
16. Other conditions deemed inappropriate for inclusion by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: RIC group; RIC+Standard medical treatment. Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mmHg.	Procedure: remote ischemic conditioning; Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mmHg. All patients underwent dynamic cerebral autoregulation before treatment, immediately after treatment, 6 hours after treatment and 24 hours after treatment.
SHAM_COMPARATOR: control group; Sham RIC+Standard medical treatment. Sham remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mmHg.	Procedure: sham remote ischemic conditioning; Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mmHg. All patients underwent dynamic cerebral autoregulation before treatment, immediately after treatment, 6 hours after treatment and 24 hours after treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic cerebral autoregulation parameters (PD)	Dynamic brain autoregulation parameters obtained from transfer function analysis in degrees. Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameters.	0-6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic cerebral autoregulation parameters (PD)	Dynamic brain autoregulation parameters obtained from transfer function analysis in degrees. Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameters.	0-1 hours
Dynamic cerebral autoregulation parameters (PD)	Dynamic brain autoregulation parameters obtained from transfer function analysis in degrees. Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameters.	0-24 hours

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 10, 2022
• Primary Completion (ANTICIPATED): February 28, 2023
• Study Completion (ANTICIPATED): February 28, 2023

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (ACTUAL): October 31, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 12, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Stroke; Ischemic Stroke; Ischemia; Carotid Stenosis; Arteriosclerosis
• Other Study ID Numbers: RIC-DCAS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No