Status:
UNKNOWN
Remote Ischemic Conditioning for Cerebral Amyloid Angiopathy-related Intracerebral Hemorrhage
Lead Sponsor:
Capital Medical University
Collaborating Sponsors:
Wangjing Hospital, China Academy of Chinese Medical Sciences
Bejing Fengtai You'anmen Hospital
Conditions:
Intracerebral Hemorrhage Lobar
Cerebral Amyloid Angiopathy
Eligibility:
All Genders
55-85 years
Phase:
NA
Brief Summary
Cerebral amyloid angiopathy-related intracerebral (CAAH) hemorrhage is second factor of primary intracerebral hemorrhage. However, no effective prevention and treatment strategies have been establishe...
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, accoun...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04757597
Start Date
February 24 2021
End Date
June 1 2022
Last Update
June 16 2021
Active Locations (1)
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1
Xuan Wu Hospital，Capital Medical University
Beijing, Beijing Municipality, China, 100069