Cerebral Amyloid AngiopathyNCT05207475
Safety and Efficacy of Remote Ischemic Conditioning on Cerebral Amyloid Angiopathy. (RIC-CAA)
A study testing Remote ischemic conditioning in people with Cerebral Amyloid Angiopathy, run by Capital Medical University at 1 site in China.
Trial summary
Cerebral amyloid angiopathy (CAA) is a common form of cerebral small vessel disease, characterized by symptomatic intracerebral hemorrhage and cognitive impairment. However, no effective prevention and treatment strategies have been established. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Cerebral Amyloid Angiopathy
- 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
- 20 Jan 2022to 20 Jan 2022
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥55 and ≤85.
- The diagnosis of probable CAA and probable CAA with supporting pathology by the Boston criteria.
- Signed and dated informed consented is obtained.
Who cannot join
- Familial hereditary CAA or other hereditary small-vessel disorders.
- Previous intracranial hemorrhage caused by other reasons, such as tumor, cerebral cavernous angioma, ruptured aneurysm, arteriovenous malformation, venous sinus thrombosis and so on.
- A history of stroke within 3 months.
- The degree of intracranial or extracranial large artery stenosis >50%.
- Clinical diagnosis of probable AD by National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
- Significant cognitive impairment (defined as Mini-mental State Examination (MMSE) score of ≥20 (primary school) or ≥24 (junior school or above) or other diseases resulting from severe cognitive impairment.
Show all 19Show fewer
- Inability to walk 6m unaided or other conditions that affected gait performance, such as Parkinson.
- Illiteracy and patients with severe visual or hearing impairment.
- Contraindication to MRI scan, such as intracranial metal implants, cardiac pacemaker, severe claustrophobia, history of seizures and so on.
- Patients with missing or poor-quality MRI sequences at baseline and follow-up.
- Patients with a pre-existing neurological deficits (modified Ranks scale score >2) or psychiatric disease that would confound the neurological or functional evaluations.
- Alcohol dependence and other psychoactive substance abuse
- Contraindication for remote ischemic conditioning: severe soft tissue injury, limb deformities, fracture, atrial fibrillation or peripheral vascular disease in the upper limbs.
- Life expectancy of less than 1 year due to co-morbid conditions.
- Severe, sustained hypertension (SBP > 180 mmHg or DBP > 110 mmHg).
- Severe renal or hepatic disease.
- Known pregnancy (or positive pregnancy test), or breast-feeding.
- Concurrent participation in another research protocol for investigation of another experimental therapy.
- Any condition which, in the judgment of the investigator, might increase the risk to the patient.
Trial locations and contacts
1 site in 1 country.
Mengke Zhang, MD contact
China1 site, 1 recruiting
- Recruiting
Xuan Wu Hospital，Capital Medical University
Beijing, Beijing Municipality, 100069
Xunming Ji, 861013120136877, jixunming@vip.163.com
About this study
Official title: Safety and Efficacy of Remote Ischemic Conditioning in Patients With Cerebral Amyloid Angiopathy: A Prospective, Randomized, Controlled Study
Cerebral amyloid angiopathy (CAA) is a common form of cerebral small vessel disease, characterized by symptomatic intracerebral hemorrhage and cognitive impairment. However, no effective prevention and treatment strategies have been established. This study aims to evaluate the safety and efficacy of remote ischemic conditioning on patients with CAA.
Read the detailed description
CAA is a cerebrovascular disease caused by the deposition of β-amyloid in the walls of arteries, arterioles, and capillaries in the cerebral cortex and overlying leptomeninges. It is often associated with repeated lobar intracerebral hemorrhages, progressive cognitive decline, transient neurological symptoms and gait disturbances. No treatment is specific for symptomatic management of CAA up to date. Remote ischemic conditioning 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 cerebral small-vessel disease in slowing cognition decline and reducing white matter hyperintensities. Thereby, investigators design this study to assess whether RIC has a beneficial effect on CAA.
- Conditions
- Cerebral Amyloid Angiopathy
- Being tested
- Remote ischemic conditioning
- Medical subject headings
- Cerebral Amyloid Angiopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioningDevice
RIC is a non-invasive therapy that performed by an electric auto-control device with cuff placed on arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on one arm. The procedure will be performed twice daily for consecutive 1 years after enrollment.
| Study group | Role | What they receive |
|---|---|---|
| RIC group | Experimental | RIC treatment and regular treatment. Receives: Device: Remote ischemic conditioning |
| Regular treatment | No intervention | Regular treatment alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of volume of WMHs.
The volume of WMHs was measured on Flairs at 6months and 12months.
Measured: From baseline to 6 months and 1 year treatment.
Secondary outcomes (8)
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 6 months and 1 year treatment.
Incidence of cardio-cerebral vascular events.
Incidence of cardiovascular and cerebrovascular events,such as Intracranial hemorrhage, subarachnoid hemorrhage, CAA-related transient focal neurological episodes（CAA-TFNEs）, CAA-related Inflammation（CAA-ri），ischemic stroke during follow-up.
Measured: From baseline to 6 months and 1 year treatment.
Changes of the cerebral blood flow in MRI ASL.
Changes of the CBF are assessed by Arterial Spin Labeling (ASL) MRI techniques at 6months and 12months.
Measured: From baseline to 6 months and 1 year treatment.
Changes of cognition evaluation on MoCA.
We used MoCA to evaluate the cognitive functions,of subjects at 6months and 12months, such as memory, execution, visuospatial function and so on.
Measured: From baseline to 6 months and 1 year treatment.
Changes of cognition evaluation on TMT tests.
We used TMT tests to evaluate execution and and so on at 6months and 12months.
Measured: From baseline to 6 months and 1 year treatment.
Changes of cognition evaluation on stroop tests.
We used stroop tests to evaluate execution and and so on at 6months and 12months.
Measured: From baseline to 6 months and 1 year treatment.
Changes in evaluation of Timed-Up-and-Go tests.
We used Timed-Up-and-Go tests to evaluate the gait function of subjects at 6months and 12months.
Measured: From baseline to 6 months and 1 year treatment.
Changes of the whole volume of microbleeds.
The volume of microbleeds was measured on QSM at 6months and 12months.
Measured: From baseline to 6 months and 1 year treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start20 Jan 2022 (estimated)
- Primary completion20 Jan 2022 (estimated)
- Study completion20 Jan 2022 (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 Amyloid AngiopathyStudies 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
- NCT05207475
- Sponsor's protocol ID
- RIC-CAA
- Status last verified
- Jan 2022
- First submitted
- 13 Jul 2021
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang 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 29042490Chen SJ, Tsai HH, Tsai LK, Tang SC, Lee BC, Liu HM, Yen RF, Jeng JS. Advances in cerebral amyloid angiopathy imaging. Ther Adv Neurol Disord. 2019 May 3;12:1756286419844113. doi: 10.1177/1756286419844113. eCollection 2019.
PubMed 31105769
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 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 Cerebral Amyloid Angiopathy: A Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT05207475
- Acronym / sponsor ID
- RIC-CAA
- Conditions
- Cerebral Amyloid Angiopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 20 Jan 2022 (estimated)
- Primary completion
- 20 Jan 2022 (estimated)
- Study completion
- 20 Jan 2022 (estimated)
- First posted
- 26 Jan 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.
Cerebral amyloid angiopathy (CAA) is a common form of cerebral small vessel disease, characterized by symptomatic intracerebral hemorrhage and cognitive impairment. However, no effective prevention and treatment strategies have been established. This study aims to evaluate the safety and efficacy of remote ischemic conditioning on patients with CAA.
Detailed description
CAA is a cerebrovascular disease caused by the deposition of β-amyloid in the walls of arteries, arterioles, and capillaries in the cerebral cortex and overlying leptomeninges. It is often associated with repeated lobar intracerebral hemorrhages, progressive cognitive decline, transient neurological symptoms and gait disturbances. No treatment is specific for symptomatic management of CAA up to date. Remote ischemic conditioning 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 cerebral small-vessel disease in slowing cognition decline and reducing white matter hyperintensities. Thereby, investigators design this study to assess whether RIC has a beneficial effect on CAA.
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 conditioningRIC treatment and regular treatment. |
| Regular treatment | No intervention | –Regular treatment alone. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age≥55 and ≤85.
- The diagnosis of probable CAA and probable CAA with supporting pathology by the Boston criteria.
- Signed and dated informed consented is obtained.
Key exclusion criteria (19 listed)
- Familial hereditary CAA or other hereditary small-vessel disorders.
- Previous intracranial hemorrhage caused by other reasons, such as tumor, cerebral cavernous angioma, ruptured aneurysm, arteriovenous malformation, venous sinus thrombosis and so on.
- A history of stroke within 3 months.
- The degree of intracranial or extracranial large artery stenosis >50%.
- Clinical diagnosis of probable AD by National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
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 conditioningRIC is a non-invasive therapy that performed by an electric auto-control device with cuff placed on arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on one arm. The procedure will be performed twice daily for consecutive 1 years after enrollment. | Device | RIC group |
Primary outcome
Changes of volume of WMHs.
Time frame: From baseline to 6 months and 1 year treatment.
The volume of WMHs was measured on Flairs at 6months and 12months.
8 secondary outcomes
Adverse events related to RIC treatment.
Time frame: From baseline to 6 months and 1 year treatment.
Incidence of cardio-cerebral vascular events.
Time frame: From baseline to 6 months and 1 year treatment.
Changes of the cerebral blood flow in MRI ASL.
Time frame: From baseline to 6 months and 1 year treatment.
Changes of cognition evaluation on MoCA.
Time frame: From baseline to 6 months and 1 year treatment.
Changes of cognition evaluation on TMT tests.
Time frame: From baseline to 6 months and 1 year treatment.
Changes of cognition evaluation on stroop tests.
Time frame: From baseline to 6 months and 1 year treatment.
Changes in evaluation of Timed-Up-and-Go tests.
Time frame: From baseline to 6 months and 1 year treatment.
Changes of the whole volume of microbleeds.
Time frame: From baseline to 6 months and 1 year treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Background: 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.
- Background: PubMed 31105769Chen SJ, Tsai HH, Tsai LK, Tang SC, Lee BC, Liu HM, Yen RF, Jeng JS. Advances in cerebral amyloid angiopathy imaging. Ther Adv Neurol Disord. 2019 May 3;12:1756286419844113. doi: 10.1177/1756286419844113. eCollection 2019.
- 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.
Mengke Zhang, MD contact
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 Amyloid Angiopathy, 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 3 inclusion and 19 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 26 Jan 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?
Changes of volume of WMHs. (time frame: From baseline to 6 months and 1 year treatment.). 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 NCT05207475, 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 26 Jan 2022.