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Non-invasive Evaluation of Cerebrovascular Reactivity in Spontaneous Intracerebral Hemorrhage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03815513
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : January 24, 2019
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Other: brain MRI Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Both patient with intracerebral hemorrhage and healthy control will receive brain MRI with Dipyridamole stimulation for cerebrovascular reactivity measurement.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non-invasive Evaluation of Cerebrovascular Reactivity in Spontaneous Intracerebral Hemorrhage
Estimated Study Start Date : January 21, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: cases
Patient with spontaneous intracerebral hemorrhage
Other: brain MRI
both case and control groups received brain MRI to evaluate cerebrovascular reactivity

Experimental: controls
Healthy control without history of symptomatic cerebrovascular diseases
Other: brain MRI
both case and control groups received brain MRI to evaluate cerebrovascular reactivity

Primary Outcome Measures :
  1. Intracerebral hemorrhage recurrence [ Time Frame: The patients will be follow up in the outpatient clinic for 2 years. ]
    Symptomatic intracerebral hemorrhage recurrence during follow-up

  2. Ischemic stroke recurrence [ Time Frame: The patients will be follow up in the outpatient clinic for 2 years. ]
    Symptomatic ischemic stroke recurrence during follow-up

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03815513

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Contact: Bo-Ching Lee, MD +886 972653442
Contact: Hsin-Hsi Tsai, MD +886 939916897

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National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10048
Contact: Bo-Ching Lee, MD         
Sponsors and Collaborators
National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital Identifier: NCT03815513     History of Changes
Other Study ID Numbers: 201811003RINB
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by National Taiwan University Hospital:
Intracerebral hemorrhage

Additional relevant MeSH terms:
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Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases