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Completed

NCT Number: NCT03789357

Prevalence of Primary Aldosteronism in Patients With Stroke

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.

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Key information

Conditions

Primary Aldosteronism Adrenal Gland Diseases Adrenocortical Hyperfunction Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Endocrine System Diseases Heart Diseases Hyperaldosteronism Hypertension Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Changi General Hospital

Singapore, 529889

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

a. Pregnant patients

Treatment and study plan

Aldosterone renin ratio

Diagnostic Test

Aldosterone Renin Ratio to screen for Primary Aldosteronism

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. Percentage of unilateral primary aldosteronism in patients admitted with acute stroke

    Time frame: 6 months

    Percentage of unilateral PA amongst patients with stroke

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

    Time frame: 3 months

  4. Blood pressure change after treatment for primary aldosteronism

    Time frame: 12 months

  5. 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

Sponsors and collaborators

Lead sponsor

Changi General Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 28, 2018
Registry last updated
May 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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