Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism

NCT ID: NCT03821571

Last Updated: 2019-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-25

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patient with primary aldosteronism

Brain MRI with T1WI, T2WI, FLAIR, thin-sliced T1WI, DWI, TOF, and blood sensitive sequence (SWI) will be performed.

Group Type EXPERIMENTAL

Brain MRI

Intervention Type DIAGNOSTIC_TEST

Brain MRI with blood sensitive sequence (SWI) will be performed to all enrolled patients.

Patient with essential hypertension

Brain MRI with T1WI, T2WI, FLAIR, thin-sliced T1WI, DWI, TOF, and blood sensitive sequence (SWI) will be performed.

Group Type ACTIVE_COMPARATOR

Brain MRI

Intervention Type DIAGNOSTIC_TEST

Brain MRI with blood sensitive sequence (SWI) will be performed to all enrolled patients.

Interventions

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Brain MRI

Brain MRI with blood sensitive sequence (SWI) will be performed to all enrolled patients.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hsin-Hsi Tsai, MD

Role: PRINCIPAL_INVESTIGATOR

Bei-Hu branch, National Taiwan University Hospital

Locations

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Bei-Hu Branch, National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Hsin-Hsi Tsai

Role: CONTACT

+886 939916897

Bo-Ching Lee, MD

Role: CONTACT

+886 972653442

Facility Contacts

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Hsin-Hsi Tsai, MD

Role: primary

+886 939916897

Other Identifiers

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201811039RIND

Identifier Type: -

Identifier Source: org_study_id

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