Carotid StenosisNCT05599009
Remote Ischemic Conditioning and Dynamic Cerebral Autoregulation in Patients With Intracranial and Extracranial Arteriosclerosis
A study testing remote ischemic conditioning in people with Carotid Stenosis and Ischemic Stroke, run by The First Hospital of Jilin University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Carotid Stenosis, Ischemic Stroke
- What is being tested?
- remote ischemic conditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 2 sitesChina
- Study dates
- 10 Dec 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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;
- Other conditions deemed inappropriate for inclusion by the investigator
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
First Hospital of Jilin University
Changchun, Jilin, 130000
Zhenni Guo, 043188782080, zhen1ni2@163.com
- Not yet recruiting
First Hospital of Jilin University
Changchun, Jilin, 130000
Yi Yang, MD, PhD, doctoryangyi@163.com
About this study
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.
Read the 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.
- Conditions
- Carotid Stenosis, Ischemic Stroke
- Being tested
- remote ischemic conditioning, sham remote ischemic conditioning
- Medical subject headings
- Carotid Stenosis, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote ischemic conditioningProcedure or surgery
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 remote ischemic conditioningProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: sham remote ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-6 hours
Secondary outcomes (2)
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.
Measured: 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.
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start10 Dec 2022
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599009
- Sponsor's protocol ID
- RIC-DCAS
- Status last verified
- Oct 2022
- First submitted
- 10 Oct 2022
- Last updated
- 14 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Conditioning and Dynamic Cerebral Autoregulation in Patients With Intracranial and Extracranial Arteriosclerosis
- ClinicalTrials.gov ID
- NCT05599009
- Acronym / sponsor ID
- RIC-DCAS
- Conditions
- Carotid Stenosis, Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 10 Dec 2022 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC group | Experimental | Procedure: remote ischemic conditioningRIC+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. |
| control group | Sham comparator | Procedure: sham remote ischemic conditioningSham 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remote ischemic conditioningRemote 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. | Procedure or surgery | RIC group |
| sham remote ischemic conditioningRemote 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. | Procedure or surgery | control group |
Primary outcome
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.
2 secondary outcomes
Dynamic cerebral autoregulation parameters (PD)
Time frame: 0-1 hours
Dynamic cerebral autoregulation parameters (PD)
Time frame: 0-24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remote ischemic conditioning in people with Carotid Stenosis and Ischemic Stroke, run by The First Hospital of Jilin University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic cerebral autoregulation parameters (PD) (time frame: 0-6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.