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Prevalence of Primary Aldosteronism in Patients With Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03789357
Recruitment Status : Active, not recruiting
First Posted : December 28, 2018
Last Update Posted : March 3, 2021
Information provided by (Responsible Party):
Changi General Hospital

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
Primary Aldosteronism Stroke Diagnostic Test: Aldosterone renin ratio

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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Aldosterone

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

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes 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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03789357

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Changi General Hospital
Singapore, Singapore, 529889
Sponsors and Collaborators
Changi General Hospital
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Principal Investigator: Troy Puar, MRCP UK Changi General Hospital
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Responsible Party: Changi General Hospital Identifier: NCT03789357    
Other Study ID Numbers: PA_CVA
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Changi General Hospital:
Adrenal vein sampling
Mineralocorticoid-receptor Antagonists
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases