Primary AldosteronismNCT04203420
Prevalence of Primary Aldosteronism in Young Adults With Acute Stroke
An observational study of Primary Aldosteronism, run by Chongqing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Primary Aldosteronism
- What is being tested?
- screening and confirmatory tests
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 13 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- patients who were once admitted in the First affiliated hospital of Chongqing Medical university(CQMU), with stroke onset less than two weeks
Who cannot join
- 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-
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affilated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
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.
- Conditions
- Primary Aldosteronism
- Being tested
- screening and confirmatory tests
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screening and confirmatory testsOther
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
| Study group | Role | What they receive |
|---|---|---|
| patients with PA | patients who finally been diagnosed with primary aldosteronism Receives: Other: screening and confirmatory tests | |
| patients without PA | patients who finally been diagnosed without primary aldosteronism Receives: Other: screening and confirmatory tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of PA
to find out the proportion of PA patients in young adults with early onset of acute stroke
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start1 Jul 2017
- Primary completion1 Nov 2019
- Study completion13 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qifu Li, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203420
- Sponsor's protocol ID
- PASTROKE
- Status last verified
- Dec 2019
- First submitted
- 13 Dec 2019
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Primary Aldosteronism in Young Adults With Acute Stroke
- ClinicalTrials.gov ID
- NCT04203420
- Acronym / sponsor ID
- PASTROKE
- Conditions
- Primary Aldosteronism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with PA | – | Other: screening and confirmatory testspatients who finally been diagnosed with primary aldosteronism |
| patients without PA | – | Other: screening and confirmatory testspatients who finally been diagnosed without primary aldosteronism |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- patients who were once admitted in the First affiliated hospital of Chongqing Medical university(CQMU), with stroke onset less than two weeks
Key exclusion criteria (1 listed)
- 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-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| screening and confirmatory testsscreening test is a blood test of the ratio of plasma aldosterone concentration(PAC) and direct renin concentration(DRC), confirmatory test is Captopril Challenge test | Other | patients with PA, patients without PA |
Primary outcome
prevalence of PA
Time frame: through study completion, an average of 2 years
to find out the proportion of PA patients in young adults with early onset of acute stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Primary Aldosteronism
Not yet recruitingPhase 2
SYH2072 Tablets in Participants With Primary Aldosteronism
Primary Aldosteronism
Recruiting
Trial of Aldosterone-hybrid SteRoid for Guiding curablE Treatment of Primary Aldosteronism (TARGET-PA)
Hyperaldosteronism; Primary, Primary Aldosteronism Due to Aldosterone Producing Adenoma
RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism
Active, not recruiting
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Primary Aldosteronism, Resistant Hypertension
Active, not recruiting
Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA
Primary Aldosteronism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Aldosteronism, run by Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of PA (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2019.