Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-27 @ 10:48 AM
Study NCT ID:
NCT03789357
Status:
COMPLETED
Last Update Posted:
2022-05-20
First Post:
2018-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Primary Aldosteronism in Patients With Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006929', 'term': 'Hyperaldosteronism'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D000308', 'term': 'Adrenocortical Hyperfunction'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-19', 'studyFirstSubmitDate': '2018-12-19', 'studyFirstSubmitQcDate': '2018-12-26', 'lastUpdatePostDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with stroke with confirmed primary aldosteronism in patients admitted to the acute stroke unit for stroke', 'timeFrame': '6 months', 'description': 'Percentage of patients with confirmed Primary Aldosteronism using confirmatory test'}], 'secondaryOutcomes': [{'measure': 'Accuracy of Screening test in early period post-stroke', 'timeFrame': '3 months', 'description': '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.'}, {'measure': 'Percentage of unilateral primary aldosteronism in patients admitted with acute stroke', 'timeFrame': '6 months', 'description': 'Percentage of unilateral PA amongst patients with stroke'}, {'measure': 'Percentage of patients with positive screening test in patients admitted with acute stroke', 'timeFrame': '3 months'}, {'measure': 'Blood pressure change after treatment for primary aldosteronism', 'timeFrame': '12 months'}, {'measure': 'Cardiac Complications', 'timeFrame': '6 months', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Arrhythmia', 'Adrenal vein sampling', 'Mineralocorticoid-receptor Antagonists'], 'conditions': ['Primary Aldosteronism', 'Stroke']}, 'referencesModule': {'references': [{'pmid': '35518929', 'type': 'DERIVED', 'citation': 'Nguyen V, Tu TM, Mamauag MJB, Lai J, Saffari SE, Aw TC, Ong L, Foo RSY, Chai SC, Fones S, Zhang M, Puar TH. Primary Aldosteronism More Prevalent in Patients With Cardioembolic Stroke and Atrial Fibrillation. Front Endocrinol (Lausanne). 2022 Apr 19;13:869980. doi: 10.3389/fendo.2022.869980. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 21-80 years\n2. Admitted with acute cerebrovascular accident (CVA) or transient ischemic attack (TIA) to the ASU, CGH\n3. Patients with both ischemic and hemorrhagic strokes\n\nExclusion Criteria:\n\na. Pregnant patients'}, 'identificationModule': {'nctId': 'NCT03789357', 'briefTitle': 'Prevalence of Primary Aldosteronism in Patients With Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Changi General Hospital'}, 'officialTitle': 'Prevalence of Primary Aldosteronism in Patients With Stroke', 'orgStudyIdInfo': {'id': 'PA_CVA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single Arm', 'description': 'All patients admitted to the Acute Stroke Unit', 'interventionNames': ['Diagnostic Test: Aldosterone renin ratio']}], 'interventions': [{'name': 'Aldosterone renin ratio', 'type': 'DIAGNOSTIC_TEST', 'description': 'Aldosterone Renin Ratio to screen for Primary Aldosteronism', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '529889', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Changi General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Troy Puar, MRCP UK', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changi General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changi General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}