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

June 13, 2021 updated by: Ji Xunming,MD,PhD, Capital Medical University

Safety and Efficacy of Remote Ischemic Conditioning in Patients With Cerebral Amyloid Angiopathy-related Intracerebral Hemorrhage:A Multicenter, Randomized, Controlled Study

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100069
        • Recruiting
        • Xuan Wu Hospital,Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RIC group
RIC treatment and regular treatment.
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.
No Intervention: Regular treatment
Regular treatment alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-emergent adverse events
Time Frame: 90±7 days
Safety
90±7 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

February 13, 2021

First Submitted That Met QC Criteria

February 13, 2021

First Posted (Actual)

February 17, 2021

Study Record Updates

Last Update Posted (Actual)

June 16, 2021

Last Update Submitted That Met QC Criteria

June 13, 2021

Last Verified

June 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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