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

NCT05599009 | Unknown

• 1 other identifier: RIC-DCAS
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Carotid Stenosis; Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Dynamic cerebral autoregulation parameters (PD)

  0-1 hours

• Dynamic cerebral autoregulation parameters (PD)

  0-24 hours

Study Arms (2)

RIC group

EXPERIMENTAL

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

control group

SHAM COMPARATOR

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

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 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.

RIC group

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 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.

control group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients who undergo intravenous thrombolysis or endovascular treatment;
• Patients with consciousness disorder or restlessness who cannot cooperate with dynamic cerebral autoregulation;
• Patients whose stable cerebral blood flow velocity envelope cannot be obtained by transcranial Doppler ultrasound or whose cerebral blood vessels have not been detected;
• 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;
• CT shows cerebral hemorrhagic diseases: hemorrhagic stroke, epidural hematoma, subdural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc;
• Other intracranial lesions, such as cerebrovascular malformations, cerebral venous lesions, tumors and other diseases involving the brain craniocerebral planning for surgical treatment;
• Other serious diseases and have a life expectancy of less than 3 months;
• Serious blood system diseases or severe coagulation dysfunction;
• Severe organ dysfunction or failure;
• Previously received remote ischemic conditioning or similar treatment;
• Contraindications of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury, peripheral vascular disease in the contralateral upper limb;
• 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;
• Pregnant or lactating women;
• Participating in other clinical investigators, or having participated in other clinical investigators within 3 months before enrollment;
• Patients who do not follow up or have poor treatment compliance;

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (2)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

First Hospital of Jilin University

Changchun, Jilin, 130000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Carotid Stenosis; Ischemic Stroke

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 31, 2022
• Study Start: December 10, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: February 14, 2023

Record last verified: 2022-10

Locations

CN (2)