- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04757597
Remote Ischemic Conditioning for Cerebral Amyloid Angiopathy-related Intracerebral Hemorrhage (RIC-CAAH)
Safety and Efficacy of Remote Ischemic Conditioning in Patients With Cerebral Amyloid Angiopathy-related Intracerebral Hemorrhage:A Multicenter, Randomized, Controlled Study
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xunming Ji, MD PhD
- Phone Number: 010-83199430
- Email: jixm@ccmu.edu.cn
Study Contact Backup
- Name: Ruiwen Che, MD
- Email: rwcadl@163.com
Study Locations
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-
Beijing
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Beijing, Beijing, China, 100069
- Recruiting
- Xuan Wu Hospital,Capital Medical University
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Contact:
- xunming ji
- Phone Number: 861013120136877
- Email: jixunming@vip.163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RIC group
RIC treatment and regular treatment.
|
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.
|
No Intervention: Regular treatment
Regular treatment alone.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of treatment-emergent adverse events
Time Frame: 90±7 days
|
Safety
|
90±7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of intracerebral hematoma volume
Time Frame: 14± 2 days
|
Intracerebral hematoma volume (ml) is assessed by CT brain scan.
|
14± 2 days
|
Changes of perihematomal edema volume
Time Frame: 14± 2 days
|
Perihematomal edema volume (ml) is assessed by CT brain scan.
|
14± 2 days
|
Incidence rate of the perihematomal edema expansion
Time Frame: 14± 2 days
|
The enlargement of perihematomal edema volume (ml) is assessed by CT brain scan.
|
14± 2 days
|
Shift of midline brain structure
Time Frame: 14± 2 days
|
Shift of midline brain structure (mm) is assessed by CT brain scan
|
14± 2 days
|
Prognosis of function outcome at 90 Days
Time Frame: 90±7 days
|
accessed by modified Rankin score
|
90±7 days
|
Prognosis of neurological function at 90 Days
Time Frame: 90±7 days
|
The Barthel index will be assessed at follow-up.
|
90±7 days
|
Changes of serum biomarker of blood brain barrier (Matrix metalloproteinases,MMPs)
Time Frame: 7± 2 days
|
The biomarker of blood brain barrier(MMPs) are assemented by the same laboratory.
|
7± 2 days
|
Changes of serum biomarker of inflammatory ( interleukin)
Time Frame: 7± 2 days
|
The interleukin will be assemented by the same laboratory.
|
7± 2 days
|
Other adverse events related to RIC treatment
Time Frame: 90±7 days
|
Other adverse events related to RIC treatment,such as mucocutaneous hemorrhage,changes in coagulation function and so on.
|
90±7 days
|
Collaborators and Investigators
Publications and helpful links
General 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.
- Arima 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Genetic Diseases, Inborn
- Proteostasis Deficiencies
- Metabolism, Inborn Errors
- Brain Diseases, Metabolic
- Brain Diseases, Metabolic, Inborn
- Cerebral Arterial Diseases
- Intracranial Arterial Diseases
- Intracranial Hemorrhages
- Cerebral Small Vessel Diseases
- Amyloidosis, Familial
- Hemorrhage
- Amyloidosis
- Cerebral Hemorrhage
- Cerebral Amyloid Angiopathy
- Cerebral Amyloid Angiopathy, Familial
Other Study ID Numbers
- RIC-CAAH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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