Prevalence of Primary Aldosteronism in Patients With Stroke

Sponsor
Changi General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03789357
Collaborator
(none)
300
1
41
7.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Aldosterone renin ratio

Study Design

Study Type:
Observational
Actual Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prevalence of Primary Aldosteronism in Patients With Stroke
Actual Study Start Date :
May 1, 2018
Actual Primary Completion Date :
Jul 31, 2021
Actual Study Completion Date :
Sep 30, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Percentage of patients with stroke with confirmed primary aldosteronism in patients admitted to the acute stroke unit for stroke [6 months]

    Percentage of patients with confirmed Primary Aldosteronism using confirmatory test

Secondary Outcome Measures

  1. Accuracy of Screening test in early period post-stroke [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.

  2. Percentage of unilateral primary aldosteronism in patients admitted with acute stroke [6 months]

    Percentage of unilateral PA amongst patients with stroke

  3. Percentage of patients with positive screening test in patients admitted with acute stroke [3 months]

  4. Blood pressure change after treatment for primary aldosteronism [12 months]

  5. Cardiac Complications [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 80 Years
Sexes Eligible for Study:
All
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:
  1. Pregnant patients

Contacts and Locations

Locations

Site City State Country Postal Code
1 Changi General Hospital Singapore Singapore 529889

Sponsors and Collaborators

  • Changi General Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Changi General Hospital
ClinicalTrials.gov Identifier:
NCT03789357
Other Study ID Numbers:
  • PA_CVA
First Posted:
Dec 28, 2018
Last Update Posted:
May 20, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Changi General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 20, 2022