JPRN-jRCT1030230229
Recruiting
未知
Invasive cerebral small vessel function assessment study for HTRA1-related cerebral small vessel disease including CARASI
Onodera Osamu0 sites25 target enrollmentJuly 14, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- CARASIL, HTRA1-related cerebral small vessel disease
- Sponsor
- Onodera Osamu
- Enrollment
- 25
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patient group is defined as those between 20 and 80 years of age with confirmed HTRA1 mutation or with clinical symptoms and imaging findings consistent with HTRA1\-associated cerebral small vessel disease in second\-degree relatives of HTRA1 mutation\-positive patients.
- •The healthy group is those who are between 20 and 80 years of age and have not been clinically diagnosed with dementia.
Exclusion Criteria
- •1\) Patients who have been treated with a prohibited concomitant drug within the last 12 weeks prior to enrollment.
- •2\) Patients who have initiated or changed the dosage of a prohibited concomitant medication within the past 4 weeks prior to enrollment.
- •3\) Patients with active infections requiring systemic treatment
- •4\) Patients with severe renal impairment (eGFR \< 30 mL/min/1\.73 m2\)
- •5\) Patients with severe hepatic impairment (AST (GOT) or ALT (GPT) \> 100 U/L)
- •6\) Patients with abnormal serum sodium or potassium levels requiring therapeutic correction.
- •7\) Patients with a 12\-lead ECG showing QT prolongation or shortening requiring therapeutic correction.
- •8\) Patients with a history of cerebral infarction, intracranial hemorrhage, transient ischemic attack, or cerebral aneurysm with a high probability of rupture diagnosed within the last 12 weeks prior to enrollment.
- •9\) Patients being treated for or with a history of coronary artery disease (angina, myocardial infarction).
- •10\) Patients with poorly controlled respiratory disease (asthma, chronic obstructive pulmonary disease, etc.)
Outcomes
Primary Outcomes
Not specified
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