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Clinical Trials/JPRN-jRCT1030230229
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.

Registry
who.int
Start Date
July 14, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Other

Investigators

Sponsor
Onodera Osamu

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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