Status:
UNKNOWN
Safety and Efficacy of Remote Ischemic Conditioning on Cerebral Amyloid Angiopathy. (RIC-CAA)
Lead Sponsor:
Capital Medical University
Conditions:
Cerebral Amyloid Angiopathy
Eligibility:
All Genders
55-85 years
Phase:
NA
Brief 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 an...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
January 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 20 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05207475
Start Date
January 20 2022
End Date
January 20 2022
Last Update
January 26 2022
Active Locations (1)
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1
Xuan Wu Hospital，Capital Medical University
Beijing, Beijing Municipality, China, 100069