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

Primary Purpose

Cerebral Amyloid Angiopathy

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Remote ischemic conditioning

About this trial

This is an interventional treatment trial for Cerebral Amyloid Angiopathy

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Xuan Wu Hospital，Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

RIC group

Regular treatment

Arm Description

RIC treatment and regular treatment.

Regular treatment alone.

Outcomes

Primary Outcome Measures

Changes of volume of WMHs.

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

Secondary Outcome Measures

Adverse events related to RIC treatment.

Adverse events related to RIC treatment, such as mucocutaneous hemorrhage, changes in coagulation function and so on.

Incidence of cardio-cerebral vascular events.

Incidence of cardiovascular and cerebrovascular events,such as Intracranial hemorrhage, subarachnoid hemorrhage, CAA-related transient focal neurological episodes（CAA-TFNEs）, CAA-related Inflammation（CAA-ri），ischemic stroke during follow-up.

Changes of the cerebral blood flow in MRI ASL.

Changes of the CBF are assessed by Arterial Spin Labeling (ASL) MRI techniques at 6months and 12months.

Changes of cognition evaluation on MoCA.

We used MoCA to evaluate the cognitive functions,of subjects at 6months and 12months, such as memory, execution, visuospatial function and so on.

Changes of cognition evaluation on TMT tests.

We used TMT tests to evaluate execution and and so on at 6months and 12months.

Changes of cognition evaluation on stroop tests.

We used stroop tests to evaluate execution and and so on at 6months and 12months.

Changes in evaluation of Timed-Up-and-Go tests.

We used Timed-Up-and-Go tests to evaluate the gait function of subjects at 6months and 12months.

Changes of the whole volume of microbleeds.

The volume of microbleeds was measured on QSM at 6months and 12months.

Full Information

NCT ID

NCT05207475

First Posted

July 13, 2021

Last Updated

January 12, 2022

Sponsor

Capital Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05207475

Brief Title

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

Official Title

Safety and Efficacy of Remote Ischemic Conditioning in Patients With Cerebral Amyloid Angiopathy: A Prospective, Randomized, Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 20, 2022 (Anticipated)

Primary Completion Date

January 20, 2022 (Anticipated)

Study Completion Date

January 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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 with repeated lobar intracerebral hemorrhages, progressive cognitive decline, transient neurological symptoms and gait disturbances. No treatment is specific for symptomatic management of CAA up to date. Remote ischemic conditioning is a non-invasive strategy to protect the brain. The clinical trials have demonstrated that daily limb RIC seems to be potentially effective in patients with cerebral small-vessel disease in slowing cognition decline and reducing white matter hyperintensities. Thereby, investigators design this study to assess whether RIC has a beneficial effect on CAA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Amyloid Angiopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RIC group

Arm Type

Experimental

Arm Description

RIC treatment and regular treatment.

Arm Title

Regular treatment

Arm Type

No Intervention

Arm Description

Regular treatment alone.

Intervention Type

Device

Intervention Name(s)

Remote ischemic conditioning

Intervention Description

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.

Primary Outcome Measure Information:

Title

Changes of volume of WMHs.

Description

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

Time Frame

From baseline to 6 months and 1 year treatment.

Secondary Outcome Measure Information:

Title

Adverse events related to RIC treatment.

Description

Adverse events related to RIC treatment, such as mucocutaneous hemorrhage, changes in coagulation function and so on.

Time Frame

From baseline to 6 months and 1 year treatment.

Title

Incidence of cardio-cerebral vascular events.

Description

Time Frame

From baseline to 6 months and 1 year treatment.

Title

Changes of the cerebral blood flow in MRI ASL.

Description

Changes of the CBF are assessed by Arterial Spin Labeling (ASL) MRI techniques at 6months and 12months.

Time Frame

From baseline to 6 months and 1 year treatment.

Title

Changes of cognition evaluation on MoCA.

Description

We used MoCA to evaluate the cognitive functions,of subjects at 6months and 12months, such as memory, execution, visuospatial function and so on.

Time Frame

From baseline to 6 months and 1 year treatment.

Title

Changes of cognition evaluation on TMT tests.

Description

We used TMT tests to evaluate execution and and so on at 6months and 12months.

Time Frame

From baseline to 6 months and 1 year treatment.

Title

Changes of cognition evaluation on stroop tests.

Description

We used stroop tests to evaluate execution and and so on at 6months and 12months.

Time Frame

From baseline to 6 months and 1 year treatment.

Title

Changes in evaluation of Timed-Up-and-Go tests.

Description

We used Timed-Up-and-Go tests to evaluate the gait function of subjects at 6months and 12months.

Time Frame

From baseline to 6 months and 1 year treatment.

Title

Changes of the whole volume of microbleeds.

Description

The volume of microbleeds was measured on QSM at 6months and 12months.

Time Frame

From baseline to 6 months and 1 year treatment.

10. Eligibility

Sex

All

Gender Based

Yes

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xunming Ji, MD PhD

Phone

010-83199430

jixm@ccmu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Mengke Zhang, MD

zwzmk985@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xunming Ji, MD PhD

Organizational Affiliation

Xuanwu Hospital, Beijing

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xuan Wu Hospital，Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100069

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xunming Ji

Phone

861013120136877

jixunming@vip.163.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29042490

Citation

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.

Results Reference

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PubMed Identifier

31105769

Citation

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.

Results Reference

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

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