Cerebral Artery OcclusionNCT05342714
Remote Ischemic Conditioning for Chronic Cerebral Artery Occlusion
A study testing Remote ischemic conditioning in people with Cerebral Artery Occlusion, run by Capital Medical University at 1 site in China.
Trial summary
Chronic cerebral artery occlusion (CCAO), which is characterized by the pathophysiological change of long-term cerebral hemodynamic disorder, is one of the major risk factors affect the occurrence and recurrence of ischemic stroke. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cerebral Artery Occlusion
- What is being tested?
- Remote ischemic conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2022to 31 Mar 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Age range 40-80 years, regardless of gender;
- (2) Digital angiography (DSA) / ultrasound / CT angiography (CTA) / magnetic resonance angiography (MRA) showed unilateral internal carotid artery (ICA) or middle cerebral artery (MCA) occlusion and stenosis of any other cerebral arteries (e.g. the other side of ICA or MCA, basilar artery) < 50%;
- (3) Modified Rankin Scale (mRS) score 0-2;
- (4) Symptoms of ischemic cerebrovascular disease (ischemic stroke or TIA) due to ICA or MCA occlusions within 12 months prior to enrollment;
- (5) neurological deficits were stable ≥ 30 days after occlusion;
- (6) Magnetic resonance perfusion weighted imaging (PWI) showed mean transit time (MTT) ≥ 4s and related cerebral blood flow (rCBF) (symptomatic side/asymptomatic side) < 0.95;
- (7) The subject or its legally authorized representative is able to provide informed reports.
Who cannot join
- (1) Uncontrolled hypertension despite the use of antihypertensive drugs before enrollment (defined as systolic blood pressure ≥200mmHg);
- (2) Stenosis or occlusion of subclavian artery and upper limb artery;
- (3) Previous history of cerebral hemorrhage, including intracranial hemorrhage, ischemic stroke hemorrhage transformation, vascular malformation or intracranial tumor or other parts of the active bleeding disease;
- (4) History of brain tumor or mental illness or acute stroke ≤6 months;
- (5) Suffering from cardiogenic thrombosis diseases, such as mitral stenosis and atrial fibrillation, myocardial infarction, mural thrombosis or valvular vegetations, congestive heart failure or endocarditis within six months;
- (6) Obvious disorder of coagulation mechanism;
Show all 11Show fewer
- (7) Severe liver or kidney insufficiency, malignant tumor, or serious diseases requiring medical intervention or surgery;
- (8) There is soft tissue or blood vessel injury at the cuff compression site of RIC treatment, or other conditions that cannot tolerate RIC;
- (9) Pregnant or lactating women;
- (10) Life expectancy <6 months;
- (11) Refusal to sign informed consent, poor compliance, or inability to complete complete treatment, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital Capital Medical University
Beijing
Hongrui Ma, 17319359172, beif1995@163.com
About this study
Official title: Safety and Efficacy of Remote Ischemic Conditioning in Patients With Chronic Cerebral Artery Occlusion: A Prospective, Randomized, Controlled Study
Chronic cerebral artery occlusion (CCAO), which is characterized by the pathophysiological change of long-term cerebral hemodynamic disorder, is one of the major risk factors affect the occurrence and recurrence of ischemic stroke. However, the mechanism of CCAO injury is not clear and effective treatment is warranted. The purpose of this study is to investigate the protective effect and underlying mechanism of remote ischemic conditioning (RIC) on CCAO.
Read the detailed description
CCAO is a cerebrovascular disease due to cerebral hypo-perfusion. It is often associated with repeated ischemic stroke or transient neurological symptoms, progressive cognitive decline and reduction of daily ability. Specific and effective treatment is warranted for symptomatic management of CCAO. RIC is a non-invasive strategy to protect the brain. The clinical trials have demonstrated that daily limb RIC seems to be potentially effective in patients with symptomatic intracranial arterial stenosis in cerebral blood flow and metabolism. RIC can also ameliorate cerebral small vessel disease in slowing cognition decline and reducing white matter. Therefore, it is worth to investigate the neuroprotective mechanism of RIC for CCAO.
- Conditions
- Cerebral Artery Occlusion
- Being tested
- Remote ischemic conditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioningDevice
The LRIC treatment consisted of 5 cycles of bilateral upper limb ischemia for 5 minutes followed by reperfusion for another 5 minutes performed twice a day for a total of 180 consecutive days.The procedure was performed by using an electric autocontrol device with cuffs that inflated to a pressure of 200 mmHg during the ischemic period and deflated during the reperfusion.(Patent No.CN200820123637.X, China).
| Study group | Role | What they receive |
|---|---|---|
| RIC group | Experimental | Participants in the experimental group receive both RIC and standard clinical therapy. The RIC treatment is composed of 5 cycles of bilateral upper limb ischemia for 5 minutes followed by reperfusion for another 5 minutes performed twice a day for a total of 180 consecutive days.The procedure was performed by using an electric autocontrol device with cuffs that inflated to a pressure of 200 mmHg during the ischemic period and deflated during the reperfusion (Patent No.CN200820123637.X, China). Receives: Device: Remote ischemic conditioning |
| Control group | No intervention | Participants in the control group receive standard clinical therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of cerebral blood flow perfusion
The investigators evaluate the change of perfusion capacity of cerebral blood vessels on PWI-MRI.
Measured: 180 days
Secondary outcomes (11)
Recurrence times of stroke or transient ischemic attack (TIA)
The investigators evaluate the times of stroke or transient ischemic attack (TIA) recurrence.
Measured: 180 days
Changes of volume of WMHs
The investigators evaluate the the change of volume of WMHs on Flairs-MRI.
Measured: 180 days
Change of the direction of white matter cellulose
The investigators evaluate the change of direction of white matter cellulose on DTI-MRI.
Measured: 180 days
Change of cerebral hemoglobin oxygenation status
The investigators evaluate the change of cerebral hemoglobin oxygenation status on BOLD-rsfMRI.
Measured: 180 days
Change of collateral circulation
The investigators evaluate the change of collateral circulation on ASL-MRI.
Measured: 180 days
Change of the Montreal Cognitive Assessment (MoCA) score
The investigators evaluate the change of neurobehavioral function by the Montreal Cognitive Assessment (MoCA) score. The minimum value is 0 and maximum value is 30. The higher scores represent the better outcome.
Measured: 180 days
Change of the Verbal Fluency Test (VFT) score
The investigators evaluate the change of neurobehavioral function by the Verbal Fluency Test (VFT) score. The minimum value is 0 and without the maximum value. The higher scores represent the better outcome.
Measured: 180 days
Change of the Digit Span Forward and Backward score
The investigators evaluate the change of neurobehavioral function by the Digit Span Forward and Backward score. The minimum value is 3 and maximum value is 12. The higher scores represent the better outcome.
Measured: 180 days
Change of the Hamilton Depression-17 (HAMD-17) scale
The investigators evaluate the change of neuropsychological function by the Hamilton Depression-17 (HAMD-17) scale. The minimum value is 0 and maximum value is 54. The higher scores represent the worse outcome.
Measured: 180 days
Change of the Hamilton Anxiety (HAMA) scale
The investigators evaluate the change of neuropsychological function by the Hamilton Anxiety (HAMA) scale. The minimum value is 0 and maximum value is 56. The higher scores represent the worse outcome.
Measured: 180 days
Adverse events related to RIC treatment
Adverse events related to RIC treatment, such as mucocutaneous hemorrhage, changes in coagulation function and so on.
Measured: From baseline to 180-day treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start22 Apr 2022
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral Artery OcclusionStudies of the same condition, open and under way.
- More trials run by Capital Medical 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
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
- Investigators
- Xunming Ji, MD.PhD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342714
- Sponsor's protocol ID
- RIC-CCAO
- Status last verified
- May 2022
- First submitted
- 30 Mar 2022
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meng R, Asmaro K, Meng L, Liu Y, Ma C, Xi C, Li G, Ren C, Luo Y, Ling F, Jia J, Hua Y, Wang X, Ding Y, Lo EH, Ji X. Upper limb ischemic preconditioning prevents recurrent stroke in intracranial arterial stenosis. Neurology. 2012 Oct 30;79(18):1853-61. doi: 10.1212/WNL.0b013e318271f76a. Epub 2012 Oct 3.
PubMed 23035060Wang Y, Meng R, Song H, Liu G, Hua Y, Cui D, Zheng L, Feng W, Liebeskind DS, Fisher M, Ji X. Remote Ischemic Conditioning May Improve Outcomes of Patients With Cerebral Small-Vessel Disease. Stroke. 2017 Nov;48(11):3064-3072. doi: 10.1161/STROKEAHA.117.017691. Epub 2017 Oct 17.
PubMed 29042490
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Remote Ischemic Conditioning in Patients With Chronic Cerebral Artery Occlusion: A Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT05342714
- Acronym / sponsor ID
- RIC-CCAO
- Conditions
- Cerebral Artery Occlusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 25 Apr 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.
Chronic cerebral artery occlusion (CCAO), which is characterized by the pathophysiological change of long-term cerebral hemodynamic disorder, is one of the major risk factors affect the occurrence and recurrence of ischemic stroke. However, the mechanism of CCAO injury is not clear and effective treatment is warranted. The purpose of this study is to investigate the protective effect and underlying mechanism of remote ischemic conditioning (RIC) on CCAO.
Detailed description
CCAO is a cerebrovascular disease due to cerebral hypo-perfusion. It is often associated with repeated ischemic stroke or transient neurological symptoms, progressive cognitive decline and reduction of daily ability. Specific and effective treatment is warranted for symptomatic management of CCAO. RIC is a non-invasive strategy to protect the brain. The clinical trials have demonstrated that daily limb RIC seems to be potentially effective in patients with symptomatic intracranial arterial stenosis in cerebral blood flow and metabolism. RIC can also ameliorate cerebral small vessel disease in slowing cognition decline and reducing white matter. Therefore, it is worth to investigate the neuroprotective mechanism of RIC for CCAO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC group | Experimental | Device: Remote ischemic conditioningParticipants in the experimental group receive both RIC and standard clinical therapy. The RIC treatment is composed of 5 cycles of bilateral upper limb ischemia for 5 minutes followed by reperfusion for another 5 minutes performed twice a day for a total of 180 consecutive days.The procedure was performed by using an electric autocontrol device with cuffs that inflated to a pressure of 200 mmHg during the ischemic period and deflated during the reperfusion (Patent No.CN200820123637.X, China). |
| Control group | No intervention | –Participants in the control group receive standard clinical therapy. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- (1) Age range 40-80 years, regardless of gender;
- (2) Digital angiography (DSA) / ultrasound / CT angiography (CTA) / magnetic resonance angiography (MRA) showed unilateral internal carotid artery (ICA) or middle cerebral artery (MCA) occlusion and stenosis of any other cerebral arteries (e.g. the other side of ICA or MCA, basilar artery) < 50%;
- (3) Modified Rankin Scale (mRS) score 0-2;
- (4) Symptoms of ischemic cerebrovascular disease (ischemic stroke or TIA) due to ICA or MCA occlusions within 12 months prior to enrollment;
- (5) neurological deficits were stable ≥ 30 days after occlusion;
Key exclusion criteria (11 listed)
- (1) Uncontrolled hypertension despite the use of antihypertensive drugs before enrollment (defined as systolic blood pressure ≥200mmHg);
- (2) Stenosis or occlusion of subclavian artery and upper limb artery;
- (3) Previous history of cerebral hemorrhage, including intracranial hemorrhage, ischemic stroke hemorrhage transformation, vascular malformation or intracranial tumor or other parts of the active bleeding disease;
- (4) History of brain tumor or mental illness or acute stroke ≤6 months;
- (5) Suffering from cardiogenic thrombosis diseases, such as mitral stenosis and atrial fibrillation, myocardial infarction, mural thrombosis or valvular vegetations, congestive heart failure or endocarditis within six months;
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 conditioningThe LRIC treatment consisted of 5 cycles of bilateral upper limb ischemia for 5 minutes followed by reperfusion for another 5 minutes performed twice a day for a total of 180 consecutive days.The procedure was performed by using an electric autocontrol device with cuffs that inflated to a pressure of 200 mmHg during the ischemic period and deflated during the reperfusion.(Patent No.CN200820123637.X, China). | Device | RIC group |
Primary outcome
Change of cerebral blood flow perfusion
Time frame: 180 days
The investigators evaluate the change of perfusion capacity of cerebral blood vessels on PWI-MRI.
11 secondary outcomes
Recurrence times of stroke or transient ischemic attack (TIA)
Time frame: 180 days
Changes of volume of WMHs
Time frame: 180 days
Change of the direction of white matter cellulose
Time frame: 180 days
Change of cerebral hemoglobin oxygenation status
Time frame: 180 days
Change of collateral circulation
Time frame: 180 days
Change of the Montreal Cognitive Assessment (MoCA) score
Time frame: 180 days
Change of the Verbal Fluency Test (VFT) score
Time frame: 180 days
Change of the Digit Span Forward and Backward score
Time frame: 180 days
Change of the Hamilton Depression-17 (HAMD-17) scale
Time frame: 180 days
Change of the Hamilton Anxiety (HAMA) scale
Time frame: 180 days
Adverse events related to RIC treatment
Time frame: From baseline to 180-day treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Results publication: PubMed 23035060Meng R, Asmaro K, Meng L, Liu Y, Ma C, Xi C, Li G, Ren C, Luo Y, Ling F, Jia J, Hua Y, Wang X, Ding Y, Lo EH, Ji X. Upper limb ischemic preconditioning prevents recurrent stroke in intracranial arterial stenosis. Neurology. 2012 Oct 30;79(18):1853-61. doi: 10.1212/WNL.0b013e318271f76a. Epub 2012 Oct 3.
- Results publication: PubMed 29042490Wang Y, Meng R, Song H, Liu G, Hua Y, Cui D, Zheng L, Feng W, Liebeskind DS, Fisher M, Ji X. Remote Ischemic Conditioning May Improve Outcomes of Patients With Cerebral Small-Vessel Disease. Stroke. 2017 Nov;48(11):3064-3072. doi: 10.1161/STROKEAHA.117.017691. Epub 2017 Oct 17.
- Individual participant dataSharing planned: No
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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.
Xunming Ji, MD.PhD principal investigator
Xuanwu Hospital, Beijing
1 site 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 Cerebral Artery Occlusion, run by Capital Medical University at 1 site 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 7 inclusion and 11 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 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Contact Xunming Ji, MD.PhD (010-83199430, jixm@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of cerebral blood flow perfusion (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05342714, which also lists 2 linked publications.
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 16 May 2022.