Remote Ischemic Conditioning for Cerebral Amyloid Angiopathy-related Intracerebral Hemorrhage

Cerebral Amyloid Angiopathy Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04757597
• Other study ID #: RIC-CAAH
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: June 2021
• Source: Capital Medical University
• Contact: Xunming Ji, MD PhD
• Phone: 010-83199430
• Email: jixm[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amyloidosis
• Cerebral Amyloid Angiopathy
• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage Lobar

Intervention

Device:
• Remote ischemic conditioning
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.

Locations

Country	Name	City	State
China	Xuan Wu Hospital,Capital Medical University	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Capital Medical University	Bejing Fengtai You'anmen Hospital, Wangjing Hospital, China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events	Safety	90±7 days
Secondary	Changes of intracerebral hematoma volume	Intracerebral hematoma volume (ml) is assessed by CT brain scan.	14± 2 days
Secondary	Changes of perihematomal edema volume	Perihematomal edema volume (ml) is assessed by CT brain scan.	14± 2 days
Secondary	Incidence rate of the perihematomal edema expansion	The enlargement of perihematomal edema volume (ml) is assessed by CT brain scan.	14± 2 days
Secondary	Shift of midline brain structure	Shift of midline brain structure (mm) is assessed by CT brain scan	14± 2 days
Secondary	Prognosis of function outcome at 90 Days	accessed by modified Rankin score	90±7 days
Secondary	Prognosis of neurological function at 90 Days	The Barthel index will be assessed at follow-up.	90±7 days
Secondary	Changes of serum biomarker of blood brain barrier (Matrix metalloproteinases,MMPs)	The biomarker of blood brain barrier(MMPs) are assemented by the same laboratory.	7± 2 days
Secondary	Changes of serum biomarker of inflammatory ( interleukin)	The interleukin will be assemented by the same laboratory.	7± 2 days
Secondary	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.	90±7 days