Prevalence of Primary Aldosteronism in Patients With Stroke

NCT03789357 | Completed

• 1 other identifier: PA_CVA
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Aldosteronism; Stroke

Keywords

Hypertension; Arrhythmia; Adrenal vein sampling; Mineralocorticoid-receptor Antagonists

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Accuracy of Screening test in early period post-stroke

  3 months

• Percentage of unilateral primary aldosteronism in patients admitted with acute stroke

  6 months

• Percentage of patients with positive screening test in patients admitted with acute stroke

  3 months

• Blood pressure change after treatment for primary aldosteronism

  12 months

• Cardiac Complications

  6 months

Study Arms (1)

Single Arm

All patients admitted to the Acute Stroke Unit

Diagnostic Test: Aldosterone renin ratio

Interventions

Aldosterone renin ratio DIAGNOSTIC_TEST

Aldosterone Renin Ratio to screen for Primary Aldosteronism

Single Arm

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• a. Pregnant patients

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

Related Publications (1)

• Nguyen V, Tu TM, Mamauag MJB, Lai J, Saffari SE, Aw TC, Ong L, Foo RSY, Chai SC, Fones S, Zhang M, Puar TH. Primary Aldosteronism More Prevalent in Patients With Cardioembolic Stroke and Atrial Fibrillation. Front Endocrinol (Lausanne). 2022 Apr 19;13:869980. doi: 10.3389/fendo.2022.869980. eCollection 2022.

  PMID: 35518929 DERIVED

MeSH Terms

Conditions

Hyperaldosteronism; Stroke; Hypertension; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Troy Puar, MRCP UK

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 28, 2018
• Study Start: May 1, 2018
• Primary Completion: July 31, 2021
• Study Completion: September 30, 2021
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)