Prevalence of Primary Aldosteronism in Patients With Stroke

May 19, 2022 updated by: Changi General Hospital

Strokes leads to significant morbidity and mortality, and hypertension is the most important risk factor for strokes. It is estimated that up to 10% of patients with hypertension have the underlying, treatable condition of primary aldosteronism. Hence, we hypothesize that the prevalence of primary aldosteronism is high in patients with strokes, a complication of long-standing hypertension.

Patients admitted with an acute stroke to the Acute Stroke Unit, Changi General Hospital, will be screened for Primary Aldosteronism three months post-stroke, and confirmatory tests will be done with saline-infusion test.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 529889
        • Changi General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Prospective study to evaluate the prevalence of primary aldosteronism in patients with an acute stroke. 300 patients admitted with CVA/TIA will be enrolled into the study.

Description

Inclusion Criteria:

  1. Age 21-80 years
  2. Admitted with acute cerebrovascular accident (CVA) or transient ischemic attack (TIA) to the ASU, CGH
  3. Patients with both ischemic and hemorrhagic strokes

Exclusion Criteria:

a. Pregnant patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single Arm
All patients admitted to the Acute Stroke Unit
Diagnostic test: Aldosterone renin ratio
Aldosterone Renin Ratio to screen for Primary Aldosteronism

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with stroke with confirmed primary aldosteronism in patients admitted to the acute stroke unit for stroke
Time Frame: 6 months
Percentage of patients with confirmed Primary Aldosteronism using confirmatory test
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of Screening test in early period post-stroke
Time Frame: 3 months
To determine if the screening blood test for primary aldosteronism performed within 1 week post-stroke is equally accurate compared to being performed 2-4 months post-stroke.
3 months
Percentage of unilateral primary aldosteronism in patients admitted with acute stroke
Time Frame: 6 months
Percentage of unilateral PA amongst patients with stroke
6 months
Percentage of patients with positive screening test in patients admitted with acute stroke
Time Frame: 3 months
3 months
Blood pressure change after treatment for primary aldosteronism
Time Frame: 12 months
12 months
Cardiac Complications
Time Frame: 6 months
Cardiac complications in patients with primary aldosteronism, compared to those without primary aldosteronism, as assessed by transthoracic echocardiography features of left ventricular hypertrophy / mass, and diastolic dysfunction
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changi General Hospital

Investigators

  • Principal Investigator: Troy Puar, MRCP UK, Changi General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Actual)

July 31, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

December 19, 2018

First Submitted That Met QC Criteria

December 26, 2018

First Posted (Actual)

December 28, 2018

Study Record Updates

Last Update Posted (Actual)

May 20, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA_CVA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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