Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism
Primary Purpose
Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism
Status
Unknown status
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Brain MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism focused on measuring Hypertension,primary aldosteronism
Eligibility Criteria
Inclusion Criteria:
- age between 20-90 years-old
- patient with primary aldosteronism 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
- pregnancy
- metal implant or cardiac pacemaker
- major brain surgery
Sites / Locations
- Bei-Hu Branch, National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patient with primary aldosteronism
Patient with essential hypertension
Arm Description
Brain MRI with T1WI, T2WI, FLAIR, thin-sliced T1WI, DWI, TOF, and blood sensitive sequence (SWI) will be performed.
Brain MRI with T1WI, T2WI, FLAIR, thin-sliced T1WI, DWI, TOF, and blood sensitive sequence (SWI) will be performed.
Outcomes
Primary Outcome Measures
Cerebrovascular reactivity
Cerebrovascular reactivity measured by MRI under primary aldosteronism
Secondary Outcome Measures
Full Information
NCT ID
NCT03821571
First Posted
January 24, 2019
Last Updated
January 28, 2019
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03821571
Brief Title
Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism
Official Title
Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 25, 2019 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypertension is known to be the major risk factor for stroke. The most common cause of secondary hypertension, primary aldosteronism (PA), is characterized by the excessive secretion of aldosterone and is related to hypertension and hypokalemia. PA accounts for 3-10 % of hypertensive patients, and a higher incidence of vascular complications compared to patients with essential hypertension was observed in several studies. The vascular injury from excessive aldosterone can occur via oxidative stress and collagen remodeling, causing endothelial dysfunction and fibrosis in the vasculature.
The association between cerebral small vessel disease (cSVD) and hypertension has been well studies in the past decades. However, not much study has focused on the cSVD burden in patient with PA. The goal of this study is to understand the features of cSVD in patients with PA and for the purpose of understanding the underlying pathophysiology of cerebrovascular injury in this particular patient group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism
Keywords
Hypertension,primary aldosteronism
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient with primary aldosteronism
Arm Type
Experimental
Arm Description
Brain MRI with T1WI, T2WI, FLAIR, thin-sliced T1WI, DWI, TOF, and blood sensitive sequence (SWI) will be performed.
Arm Title
Patient with essential hypertension
Arm Type
Active Comparator
Arm Description
Brain MRI with T1WI, T2WI, FLAIR, thin-sliced T1WI, DWI, TOF, and blood sensitive sequence (SWI) will be performed.
Intervention Type
Diagnostic Test
Intervention Name(s)
Brain MRI
Intervention Description
Brain MRI with blood sensitive sequence (SWI) will be performed to all enrolled patients.
Primary Outcome Measure Information:
Title
Cerebrovascular reactivity
Description
Cerebrovascular reactivity measured by MRI under primary aldosteronism
Time Frame
During the brain MRI
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age between 20-90 years-old
patient with primary aldosteronism 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
pregnancy
metal implant or cardiac pacemaker
major brain surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsin-Hsi Tsai
Phone
+886 939916897
Email
tsaihsinhsi@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bo-Ching Lee, MD
Phone
+886 972653442
Email
bochinglee@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsin-Hsi Tsai, MD
Organizational Affiliation
Bei-Hu branch, National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bei-Hu Branch, National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsin-Hsi Tsai, MD
Phone
+886 939916897
Email
tsaihsinhsi@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism
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