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Remote Ischemic Conditioning for Cerebral Amyloid Angiopathy-related Intracerebral Hemorrhage (RIC-CAAH)

Primary Purpose

Intracerebral Hemorrhage Lobar, Cerebral Amyloid Angiopathy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Remote ischemic conditioning
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracerebral Hemorrhage Lobar

Eligibility Criteria

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

Inclusion Criteria:

  • 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 Criteria:

  • 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.

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

Incidence of treatment-emergent adverse events
Safety

Secondary Outcome Measures

Changes of intracerebral hematoma volume
Intracerebral hematoma volume (ml) is assessed by CT brain scan.
Changes of perihematomal edema volume
Perihematomal edema volume (ml) is assessed by CT brain scan.
Incidence rate of the perihematomal edema expansion
The enlargement of perihematomal edema volume (ml) is assessed by CT brain scan.
Shift of midline brain structure
Shift of midline brain structure (mm) is assessed by CT brain scan
Prognosis of function outcome at 90 Days
accessed by modified Rankin score
Prognosis of neurological function at 90 Days
The Barthel index will be assessed at follow-up.
Changes of serum biomarker of blood brain barrier (Matrix metalloproteinases，MMPs)
The biomarker of blood brain barrier（MMPs） are assemented by the same laboratory.
Changes of serum biomarker of inflammatory ( interleukin)
The interleukin will be assemented by the same laboratory.
Other adverse events related to RIC treatment
Other adverse events related to RIC treatment,such as mucocutaneous hemorrhage,changes in coagulation function and so on.

Full Information

First Posted
February 13, 2021
Last Updated
June 13, 2021
Sponsor
Capital Medical University
Collaborators
Wangjing Hospital, China Academy of Chinese Medical Sciences, Bejing Fengtai You'anmen Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04757597
Brief Title
Remote Ischemic Conditioning for Cerebral Amyloid Angiopathy-related Intracerebral Hemorrhage
Acronym
RIC-CAAH
Official Title
Safety and Efficacy of Remote Ischemic Conditioning in Patients With Cerebral Amyloid Angiopathy-related Intracerebral Hemorrhage:A Multicenter, Randomized, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University
Collaborators
Wangjing Hospital, China Academy of Chinese Medical Sciences, Bejing Fengtai You'anmen Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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, accounting for approximately 20-30%. It is often characterized by repeated and multifocal lobar hemorrhage, which will not only cause neurological deficit on the limbs, but also influence the cognitive level of patients and may even be life-threatening. At present, the role of surgery in CAA-related ICH is controversial, and there is no effective prevention and treatment strategies have been established. Additionally, it is always associated with a low rate of good prognosis(11%-60%) and a high risk of recurrent ICH (10%-60%). Thus, a novel approach which can improve the clinical outcome and reduce the risk of recurrent intracerebral hemorrhage is urgently needed. Remote ischemic conditioning (RIC) has been developed as a neuroprotective strategy to prevent and treat acute ischemic stroke and small cerebrovascular disease. Additionally, clinical research testified that RIC is safe and feasible for patients with subarachnoid hemorrhage. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage Lobar, 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 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.
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events
Description
Safety
Time Frame
90±7 days
Secondary Outcome Measure Information:
Title
Changes of intracerebral hematoma volume
Description
Intracerebral hematoma volume (ml) is assessed by CT brain scan.
Time Frame
14± 2 days
Title
Changes of perihematomal edema volume
Description
Perihematomal edema volume (ml) is assessed by CT brain scan.
Time Frame
14± 2 days
Title
Incidence rate of the perihematomal edema expansion
Description
The enlargement of perihematomal edema volume (ml) is assessed by CT brain scan.
Time Frame
14± 2 days
Title
Shift of midline brain structure
Description
Shift of midline brain structure (mm) is assessed by CT brain scan
Time Frame
14± 2 days
Title
Prognosis of function outcome at 90 Days
Description
accessed by modified Rankin score
Time Frame
90±7 days
Title
Prognosis of neurological function at 90 Days
Description
The Barthel index will be assessed at follow-up.
Time Frame
90±7 days
Title
Changes of serum biomarker of blood brain barrier (Matrix metalloproteinases，MMPs)
Description
The biomarker of blood brain barrier（MMPs） are assemented by the same laboratory.
Time Frame
7± 2 days
Title
Changes of serum biomarker of inflammatory ( interleukin)
Description
The interleukin will be assemented by the same laboratory.
Time Frame
7± 2 days
Title
Other adverse events related to RIC treatment
Description
Other adverse events related to RIC treatment,such as mucocutaneous hemorrhage,changes in coagulation function and so on.
Time Frame
90±7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xunming Ji, MD PhD
Phone
010-83199430
Email
jixm@ccmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ruiwen Che, MD
Email
rwcadl@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xunming Ji
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
Email
jixunming@vip.163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25692104
Citation
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.
Results Reference
background
PubMed Identifier
20044530
Citation
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.
Results Reference
background

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Remote Ischemic Conditioning for Cerebral Amyloid Angiopathy-related Intracerebral Hemorrhage

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