NCT04203420

Brief Summary

The guideline requires clinical works to screen for primary aldosteronism(PA) in young adults with family history of stroke at early onset. But the prevalence of PA in young adults with stroke onset before 45 years old had never been investigated. The study aimed to discover the prevalence as well as the clinical characteristics between patients with PA and those without PA during stroke attack. In order to fulfill this objective, investigators intended to conduct a cross-sectional study by taking screening and confirmatory tests among young adults who once admitted due to early onset of acute stroke.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 18, 2019

Completed
Last Updated

December 18, 2019

Status Verified

December 1, 2019

Enrollment Period

2.3 years

First QC Date

December 13, 2019

Last Update Submit

December 16, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • prevalence of PA

    to find out the proportion of PA patients in young adults with early onset of acute stroke

    through study completion, an average of 2 years

Study Arms (2)

patients with PA

patients who finally been diagnosed with primary aldosteronism

Other: screening and confirmatory tests

patients without PA

patients who finally been diagnosed without primary aldosteronism

Other: screening and confirmatory tests

Interventions

screening test is a blood test of the ratio of plasma aldosterone concentration(PAC) and direct renin concentration(DRC), confirmatory test is Captopril Challenge test

patients with PApatients without PA

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients who were once admitted in the First affiliated hospital of CQMU during Jan.2006 to Feb.2019 with stroke onset less than two weeks. Age between 18 to 45y.

You may qualify if:

  • \- patients who were once admitted in the First affiliated hospital of Chongqing Medical university(CQMU), with stroke onset less than two weeks

You may not qualify if:

  • death, serious sequela with motor, comprehensive or linguistic dysfunction, patients unwilling to join in, etiology of trauma, infective or tumor disease, patients with impaired cardiac, renal or liver function during admission-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affilated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

MeSH Terms

Conditions

Hyperaldosteronism

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Endocrinology

Study Record Dates

First Submitted

December 13, 2019

First Posted

December 18, 2019

Study Start

July 1, 2017

Primary Completion

November 1, 2019

Study Completion

December 13, 2019

Last Updated

December 18, 2019

Record last verified: 2019-12

Locations