Non-invasive Evaluation of Cerebrovascular Reactivity in Spontaneous Intracerebral Hemorrhage

Intracerebral Hemorrhage Clinical Trial

Official title:

Non-invasive Evaluation of Cerebrovascular Reactivity in Spontaneous Intracerebral Hemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03815513
• Other study ID #: 201811003RINB
• Status: Recruiting
• Phase: Phase 1
• Start date: January 21, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2018
• Source: National Taiwan University Hospital
• Contact: Bo-Ching Lee, MD
• Phone: +886 972653442
• Email: bochinglee[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Spontaneous intracerebral hemorrhage (ICH) remains a significant cause of morbidity and mortality around the globe. The most common etiology of nontraumatic spontaneous ICH is hypertensive arteriopathy (HA), while cerebral amyloid angiopathy (CAA) is the most prevalent cause of spontaneous lobar ICH in the elderly. Both HA and CAA belong to the family of cerebral small vessel disease (cSVD). cSVD involves pathological processes that affect the arteries, arterioles, capillaries, and veins on the surface and beneath the brain. The resultant changes of cSVD in the brain vasculatures can be detected with neuroimaging, includes cerebral microbleeds, white matter hyperintensities, lacunes, dilated perivascular spaces, and brain atrophy.

Investigators of this study have probe into various imaging markers in patients with cSVD. Investigators found that the lacune and cerebral microbleeds location was related to distinct underlying etiology of cSVD. Further, investigators utilized amyloid PET study to directly quantified the cerebral amyloid burden, and demonstrated the correlation between amyloid deposition and deep/superficial microbleeds ratio. The association between cerebellum microbleeds, which is a novel marker for cSVD, and the underlying pathology in patient with spontaneous ICH has been investigated. Investigators also summarized and published the current research of different cSVD imaging markers and its implication on patient care.

Cerebrovascular reactivity (CVR) represents the phenomenon that cerebral vessels dilate or constrict in response to stimuli, which provides insights into the vascular reserve information. The vascular reserve parameter is complementary to steady-state vascular index, such as cerebral perfusion or other neuroimaging markers. Measurement of CVR using advanced MR techniques is an emerging technique with multiple potential clinical utilities, and impaired autoregulation may contribute to the pathogenesis of cSVD. Recently, diminished CVR under visual stimuli has been linked to vascular amyloid deposits and related vascular dysfunction. Clarifying the mechanism of cSVD-related brain injury would be an important step towards identifying candidate treatment approaches.

The goal of this study is to understand the features of CVR in patients with cSVD-related spontaneous ICH, for the purpose of establishing new biomarkers in cSVD diagnosis and understanding the underlying pathophysiology.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• age between 20-90 years-old

• patient with spontaneous intracerebral hemorrhage or healthy control

• consciousness clear

• willing to receive brain MRI

Exclusion Criteria:

• renal failure or Creatinine > 2mg/dl

• coagulopathy or hepatic insufficiency

• unstable vital sign under inotropic agents

• allergy to Dipyridamole

• pregnancy

• asthma history

• metal implant or cardiac pacemaker

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Other:
• brain MRI
both case and control groups received brain MRI to evaluate cerebrovascular reactivity

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

Dumas A, Dierksen GA, Gurol ME, Halpin A, Martinez-Ramirez S, Schwab K, Rosand J, Viswanathan A, Salat DH, Polimeni JR, Greenberg SM. Functional magnetic resonance imaging detection of vascular reactivity in cerebral amyloid angiopathy. Ann Neurol. 2012 Jul;72(1):76-81. doi: 10.1002/ana.23566. — View Citation

Fisher M, Vasilevko V, Passos GF, Ventura C, Quiring D, Cribbs DH. Therapeutic modulation of cerebral microhemorrhage in a mouse model of cerebral amyloid angiopathy. Stroke. 2011 Nov;42(11):3300-3. doi: 10.1161/STROKEAHA.111.626655. Epub 2011 Sep 8. — View Citation

Tsai HH, Pasi M, Tsai LK, Chen YF, Lee BC, Tang SC, Fotiadis P, Huang CY, Yen RF, Gurol ME, Jeng JS. Distribution of Lacunar Infarcts in Asians With Intracerebral Hemorrhage: A Magnetic Resonance Imaging and Amyloid Positron Emission Tomography Study. Stroke. 2018 Jun;49(6):1515-1517. doi: 10.1161/STROKEAHA.118.021539. Epub 2018 Apr 25. — View Citation

Tsai HH, Tsai LK, Chen YF, Tang SC, Lee BC, Yen RF, Jeng JS. Correlation of Cerebral Microbleed Distribution to Amyloid Burden in Patients with Primary Intracerebral Hemorrhage. Sci Rep. 2017 Mar 17;7:44715. doi: 10.1038/srep44715. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracerebral hemorrhage recurrence	Symptomatic intracerebral hemorrhage recurrence during follow-up	The patients will be follow up in the outpatient clinic for 2 years.
Primary	Ischemic stroke recurrence	Symptomatic ischemic stroke recurrence during follow-up	The patients will be follow up in the outpatient clinic for 2 years.