Prevalence of Primary Aldosteronism in Patients With Stroke

Stroke Clinical Trial

Official title:

Prevalence of Primary Aldosteronism in Patients With Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03789357
• Other study ID #: PA_CVA
• Status: Completed
• Start date: May 1, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: May 2022
• Source: Changi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 30, 2021
• Est. primary completion date: July 31, 2021
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperaldosteronism
• Primary Aldosteronism
• Stroke

Intervention

Diagnostic Test:
• Aldosterone renin ratio
Aldosterone Renin Ratio to screen for Primary Aldosteronism

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with stroke with confirmed primary aldosteronism in patients admitted to the acute stroke unit for stroke	Percentage of patients with confirmed Primary Aldosteronism using confirmatory test	6 months
Secondary	Accuracy of Screening test in early period post-stroke	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
Secondary	Percentage of unilateral primary aldosteronism in patients admitted with acute stroke	Percentage of unilateral PA amongst patients with stroke	6 months
Secondary	Percentage of patients with positive screening test in patients admitted with acute stroke		3 months
Secondary	Blood pressure change after treatment for primary aldosteronism		12 months
Secondary	Cardiac Complications	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