Intracerebral Hemorrhage LobarRIC-CAAHNCT04757597
Remote Ischemic Conditioning for Cerebral Amyloid Angiopathy-related Intracerebral Hemorrhage
A study testing Remote ischemic conditioning in people with Intracerebral Hemorrhage Lobar and Cerebral Amyloid Angiopathy, run by Capital Medical University at 1 site in China.
Trial summary
Cerebral amyloid angiopathy-related intracerebral (CAAH) hemorrhage is second factor of primary intracerebral hemorrhage. However, no effective prevention and treatment strategies have been established. Remote ischemic conditioning is a neuroprotective strategy. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Intracerebral Hemorrhage Lobar, 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
- 24 Feb 2021to 1 Jun 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 single or multiple spontaneous lobar cerebral hemorrhage is confirmed by brain CT scan(defined as possible or probable CAA by the Boston criteria) .
- Hematoma volume of 10 to 50 ml.
- Glasgow Coma Score (GCS)>8.
- Without surgery.
- Starting RIC treatment between 24 and 48 hours of ictus.
- Signed and dated informed consented is obtained.
Who cannot join
- Patients with suspected secondary ICH related to tumor, coagulopathy, ruptured aneurysm or arteriovenous malformation, or venous sinus thrombosis.
- ICH concomitant with intraventricular hemorrhage, subdural hematoma, epidural hematoma subarachnoid hemorrhage or the condition of unstable vital signs which may be life-threatening.
- Evidence of significant shift of midline brain structure (>5mm) or herniation on brain imaging.
- Contraindication to MRI scan, such as intracranial metal implants, cardiac pacemaker, severe claustrophobia, history of seizures and so on
- Patients with a pre-existing neurological deficits (modified Ranks scale score >2) or psychiatric disease that would confound the neurological or functional evaluations.
- Use of warfarin or heparin within 7 days before the baseline visit
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- 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 hepatic and renal dysfunction.
- 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.
Ruiwen Che, 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-related Intracerebral Hemorrhage:A Multicenter, Randomized, Controlled Study
Cerebral amyloid angiopathy-related intracerebral (CAAH) hemorrhage is second factor of primary intracerebral hemorrhage. However, no effective prevention and treatment strategies have been established. Remote ischemic conditioning is a neuroprotective strategy. In animal studies，RIC is efficiency in accelerating the absorption of hematoma. Therefore, the investigators plan to carry out this research to evaluate the safety and efficacy of RIC in patients with CAA related ICH.
Read the detailed description
In China, primary intracerebral hemorrhage accounts for 80-85% of all types of intracerebral hemorrhage, while cerebral amyloid angiopathy-related intracerebral hemorrhage is the second factor, accounting for approximately 20-30%. It is often characterized by repeated and multifocal lobar hemorrhage, which will not only cause neurological deficit on the limbs, but also influence the cognitive level of patients and may even be life-threatening. At present, the role of surgery in CAA-related ICH is controversial, and there is no effective prevention and treatment strategies have been established. Additionally, it is always associated with a low rate of good prognosis(11%-60%) and a high risk of recurrent ICH (10%-60%). Thus, a novel approach which can improve the clinical outcome and reduce the risk of recurrent intracerebral hemorrhage is urgently needed.
Remote ischemic conditioning (RIC) has been developed as a neuroprotective strategy to prevent and treat acute ischemic stroke and small cerebrovascular disease. Additionally, clinical research testified that RIC is safe and feasible for patients with subarachnoid hemorrhage. In animal studies, RIC is efficiency in accelerating the absorption of hematoma. Therefore, the investigators plan to carry out this research to evaluate the safety and efficacy of RIC in patients with CAA related ICH.
- 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 autocontrol 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 once daily for consecutive 10-14 days 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.
Incidence of treatment-emergent adverse events
Safety
Measured: 90±7 days
Secondary outcomes (9)
Changes of intracerebral hematoma volume
Intracerebral hematoma volume (ml) is assessed by CT brain scan.
Measured: 14± 2 days
Changes of perihematomal edema volume
Perihematomal edema volume (ml) is assessed by CT brain scan.
Measured: 14± 2 days
Incidence rate of the perihematomal edema expansion
The enlargement of perihematomal edema volume (ml) is assessed by CT brain scan.
Measured: 14± 2 days
Shift of midline brain structure
Shift of midline brain structure (mm) is assessed by CT brain scan
Measured: 14± 2 days
Prognosis of function outcome at 90 Days
accessed by modified Rankin score
Measured: 90±7 days
Prognosis of neurological function at 90 Days
The Barthel index will be assessed at follow-up.
Measured: 90±7 days
Changes of serum biomarker of blood brain barrier (Matrix metalloproteinases，MMPs)
The biomarker of blood brain barrier（MMPs） are assemented by the same laboratory.
Measured: 7± 2 days
Changes of serum biomarker of inflammatory ( interleukin)
The interleukin will be assemented by the same laboratory.
Measured: 7± 2 days
Other adverse events related to RIC treatment
Other adverse events related to RIC treatment,such as mucocutaneous hemorrhage,changes in coagulation function and so on.
Measured: 90±7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start24 Feb 2021
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Jun 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 Intracerebral Hemorrhage LobarStudies 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
- Collaborators
- Wangjing Hospital, China Academy of Chinese Medical Sciences, Bejing Fengtai You'anmen Hospital
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
- Investigators
- Xunming Ji, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757597
- Sponsor's protocol ID
- RIC-CAAH
- Acronym
- RIC-CAAH
- Status last verified
- Jun 2021
- First submitted
- 13 Feb 2021
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yamada M. Cerebral amyloid angiopathy: emerging concepts. J Stroke. 2015 Jan;17(1):17-30. doi: 10.5853/jos.2015.17.1.17. Epub 2015 Jan 30.
PubMed 25692104Arima H, Tzourio C, Anderson C, Woodward M, Bousser MG, MacMahon S, Neal B, Chalmers J; PROGRESS Collaborative Group. Effects of perindopril-based lowering of blood pressure on intracerebral hemorrhage related to amyloid angiopathy: the PROGRESS trial. Stroke. 2010 Feb;41(2):394-6. doi: 10.1161/STROKEAHA.109.563932. Epub 2009 Dec 31.
PubMed 20044530
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. 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-related Intracerebral Hemorrhage:A Multicenter, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT04757597
- Acronym / sponsor ID
- RIC-CAAH / RIC-CAAH
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Wangjing Hospital, China Academy of Chinese Medical Sciences, Bejing Fengtai You'anmen Hospital
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 17 Feb 2021 (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-related intracerebral (CAAH) hemorrhage is second factor of primary intracerebral hemorrhage. However, no effective prevention and treatment strategies have been established. Remote ischemic conditioning is a neuroprotective strategy. In animal studies，RIC is efficiency in accelerating the absorption of hematoma. Therefore, the investigators plan to carry out this research to evaluate the safety and efficacy of RIC in patients with CAA related ICH.
Detailed description
In China, primary intracerebral hemorrhage accounts for 80-85% of all types of intracerebral hemorrhage, while cerebral amyloid angiopathy-related intracerebral hemorrhage is the second factor, accounting for approximately 20-30%. It is often characterized by repeated and multifocal lobar hemorrhage, which will not only cause neurological deficit on the limbs, but also influence the cognitive level of patients and may even be life-threatening. At present, the role of surgery in CAA-related ICH is controversial, and there is no effective prevention and treatment strategies have been established. Additionally, it is always associated with a low rate of good prognosis(11%-60%) and a high risk of recurrent ICH (10%-60%). Thus, a novel approach which can improve the clinical outcome and reduce the risk of recurrent intracerebral hemorrhage is urgently needed.
Remote ischemic conditioning (RIC) has been developed as a neuroprotective strategy to prevent and treat acute ischemic stroke and small cerebrovascular disease. Additionally, clinical research testified that RIC is safe and feasible for patients with subarachnoid hemorrhage. In animal studies, RIC is efficiency in accelerating the absorption of hematoma. Therefore, the investigators plan to carry out this research to evaluate the safety and efficacy of RIC in patients with CAA related ICH.
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 (7 listed)
- Age≥55 and ≤85.
- The diagnosis of single or multiple spontaneous lobar cerebral hemorrhage is confirmed by brain CT scan(defined as possible or probable CAA by the Boston criteria) .
- Hematoma volume of 10 to 50 ml.
- Glasgow Coma Score (GCS)>8.
- Without surgery.
Key exclusion criteria (13 listed)
- Patients with suspected secondary ICH related to tumor, coagulopathy, ruptured aneurysm or arteriovenous malformation, or venous sinus thrombosis.
- ICH concomitant with intraventricular hemorrhage, subdural hematoma, epidural hematoma subarachnoid hemorrhage or the condition of unstable vital signs which may be life-threatening.
- Evidence of significant shift of midline brain structure (>5mm) or herniation on brain imaging.
- Contraindication to MRI scan, such as intracranial metal implants, cardiac pacemaker, severe claustrophobia, history of seizures and so on
- Patients with a pre-existing neurological deficits (modified Ranks scale score >2) or psychiatric disease that would confound the neurological or functional evaluations.
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 autocontrol 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 once daily for consecutive 10-14 days after enrollment. | Device | RIC group |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: 90±7 days
Safety
9 secondary outcomes
Changes of intracerebral hematoma volume
Time frame: 14± 2 days
Changes of perihematomal edema volume
Time frame: 14± 2 days
Incidence rate of the perihematomal edema expansion
Time frame: 14± 2 days
Shift of midline brain structure
Time frame: 14± 2 days
Prognosis of function outcome at 90 Days
Time frame: 90±7 days
Prognosis of neurological function at 90 Days
Time frame: 90±7 days
Changes of serum biomarker of blood brain barrier (Matrix metalloproteinases，MMPs)
Time frame: 7± 2 days
Changes of serum biomarker of inflammatory ( interleukin)
Time frame: 7± 2 days
Other adverse events related to RIC treatment
Time frame: 90±7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Background: PubMed 25692104Yamada M. Cerebral amyloid angiopathy: emerging concepts. J Stroke. 2015 Jan;17(1):17-30. doi: 10.5853/jos.2015.17.1.17. Epub 2015 Jan 30.
- Background: PubMed 20044530Arima H, Tzourio C, Anderson C, Woodward M, Bousser MG, MacMahon S, Neal B, Chalmers J; PROGRESS Collaborative Group. Effects of perindopril-based lowering of blood pressure on intracerebral hemorrhage related to amyloid angiopathy: the PROGRESS trial. Stroke. 2010 Feb;41(2):394-6. doi: 10.1161/STROKEAHA.109.563932. Epub 2009 Dec 31.
- 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.
Ruiwen Che, MD contact
Xunming Ji 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 Intracerebral Hemorrhage Lobar and 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 7 inclusion and 13 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 Jun 2021. 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?
Incidence of treatment-emergent adverse events (time frame: 90±7 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 NCT04757597, 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 Jun 2021.