Remote Ischemic Conditioning for Cerebral Amyloid Angiopathy-related Intracerebral Hemorrhage

NCT04757597 | Unknown DMC

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

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 established. Remote ischemic conditioning is a neuroprotective strategy. 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.

Conditions

Intracerebral Hemorrhage Lobar; Cerebral Amyloid Angiopathy

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events

  Safety

  90±7 days

Secondary Outcomes (9)

• Changes of intracerebral hematoma volume

  14± 2 days

• Changes of perihematomal edema volume

  14± 2 days

• Incidence rate of the perihematomal edema expansion

  14± 2 days

• Shift of midline brain structure

  14± 2 days

• Prognosis of function outcome at 90 Days

  90±7 days

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 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.

RIC group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead
• Wangjing Hospital, China Academy of Chinese Medical Sciences: collaborator
• Bejing Fengtai You'anmen Hospital: collaborator

Study Sites (1)

Xuan Wu Hospital，Capital Medical University

Beijing, Beijing Municipality, 100069, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 25692104 BACKGROUND

• 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.

  PMID: 20044530 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

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xunming Ji, MD PhD

CONTACT

010-83199430; jixm@ccmu.edu.cn

Ruiwen Che, MD

CONTACT

rwcadl@163.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: February 13, 2021
• First Posted: February 17, 2021
• Study Start: February 24, 2021
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: June 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)