Safety and Efficacy of Remote Ischemic Conditioning on Cerebral Amyloid Angiopathy. (RIC-CAA)

NCT05207475 | Unknown DMC

• 1 other identifier: RIC-CAA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 and treatment strategies have been established. This study aims to evaluate the safety and efficacy of remote ischemic conditioning on patients with CAA.

Conditions

Cerebral Amyloid Angiopathy

Outcome Measures

Primary Outcomes (1)

• Changes of volume of WMHs.

  The volume of WMHs was measured on Flairs at 6months and 12months.

  From baseline to 6 months and 1 year treatment.

Secondary Outcomes (8)

• Adverse events related to RIC treatment.

  From baseline to 6 months and 1 year treatment.

• Incidence of cardio-cerebral vascular events.

  From baseline to 6 months and 1 year treatment.

• Changes of the cerebral blood flow in MRI ASL.

  From baseline to 6 months and 1 year treatment.

• Changes of cognition evaluation on MoCA.

  From baseline to 6 months and 1 year treatment.

• Changes of cognition evaluation on TMT tests.

  From baseline to 6 months and 1 year treatment.

Study Arms (2)

RIC group

EXPERIMENTAL

RIC treatment and regular treatment.

Device: Remote ischemic conditioning

Regular treatment

NO INTERVENTION

Regular treatment alone.

Interventions

Remote ischemic conditioning DEVICE

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.

RIC group

Eligibility Criteria

• Age: 55 Years - 85 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Xuan Wu Hospital，Capital Medical University

Beijing, Beijing Municipality, 100069, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 29042490 BACKGROUND

• Chen 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.

  PMID: 31105769 BACKGROUND

MeSH Terms

Conditions

Cerebral Amyloid Angiopathy

Condition Hierarchy (Ancestors)

Cerebral Arterial Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Xunming Ji, MD PhD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xunming Ji, MD PhD

CONTACT

010-83199430; jixm@ccmu.edu.cn

Mengke Zhang, MD

CONTACT

zwzmk985@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: January 26, 2022
• Study Start: January 20, 2022
• Primary Completion: January 20, 2022
• Study Completion: January 20, 2022
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)