Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-03-05 @ 7:52 PM
Study NCT ID:
NCT04203420
Status:
COMPLETED
Last Update Posted:
2019-12-18
First Post:
2019-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Primary Aldosteronism in Young Adults With Acute Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006929', 'term': 'Hyperaldosteronism'}], 'ancestors': [{'id': 'D000308', 'term': 'Adrenocortical Hyperfunction'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008403', 'term': 'Mass Screening'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015980', 'term': 'Public Health Practice'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-16', 'studyFirstSubmitDate': '2019-12-13', 'studyFirstSubmitQcDate': '2019-12-16', 'lastUpdatePostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of PA', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'to find out the proportion of PA patients in young adults with early onset of acute stroke'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Aldosteronism']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- patients who were once admitted in the First affiliated hospital of Chongqing Medical university(CQMU), with stroke onset less than two weeks\n\nExclusion Criteria:\n\ndeath, 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-'}, 'identificationModule': {'nctId': 'NCT04203420', 'briefTitle': 'Prevalence of Primary Aldosteronism in Young Adults With Acute Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Chongqing Medical University'}, 'officialTitle': 'Prevalence of Primary Aldosteronism in Young Adults With Acute Stroke', 'orgStudyIdInfo': {'id': 'PASTROKE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with PA', 'description': 'patients who finally been diagnosed with primary aldosteronism', 'interventionNames': ['Other: screening and confirmatory tests']}, {'label': 'patients without PA', 'description': 'patients who finally been diagnosed without primary aldosteronism', 'interventionNames': ['Other: screening and confirmatory tests']}], 'interventions': [{'name': 'screening and confirmatory tests', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['patients with PA', 'patients without PA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400016', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'The First Affilated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chongqing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department of Endocrinology', 'investigatorFullName': 'Qifu Li', 'investigatorAffiliation': 'Chongqing Medical University'}}}}