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

February 12, 2023 updated by: The First Hospital of Jilin University
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130000
        • Recruiting
        • First Hospital of Jilin University
        • Contact:
      • Changchun, Jilin, China, 130000
        • Not yet recruiting
        • First Hospital of Jilin University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dynamic cerebral autoregulation parameters (PD)
Time Frame: 0-6 hours
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dynamic cerebral autoregulation parameters (PD)
Time Frame: 0-1 hours
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)
Time Frame: 0-24 hours
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Hospital of Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2022

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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