Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT05174533
Status:
UNKNOWN
Last Update Posted:
2022-02-01
First Post:
2021-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence of Cardiovascular Disorders in Patients Aged 40 and More With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-07-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-17', 'studyFirstSubmitDate': '2021-12-13', 'studyFirstSubmitQcDate': '2021-12-13', 'lastUpdatePostDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QRS morphology', 'timeFrame': 'Day 0', 'description': 'variation of QRS waves according a standard 12-lead ECG'}], 'secondaryOutcomes': [{'measure': 'cardiac rhythm', 'timeFrame': 'Day 0', 'description': 'cardiac rhythm disorder according a standard 12-lead ECG'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['schizophrenia', 'cardiovascular disorders', 'prevalence'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'Schizophrenia is a psychiatric disorder, affecting 600,000 patients in France. Patients with schizophrenia have life expectancy decrease from 10 to 20 years because of cardiovascular death. Cardiovascular risk factors are numerous: inadequate diet, smoking, alcohol consumption, diabetes, obesity. Primary prevention of cardiovascular risk in patients suffering from schizophrenia is difficult because of understaff in general practitioners and psychiatrists.', 'detailedDescription': 'The aim of the study is to describe prevalence of cardiovascular disorders in patients aged 40 and more with schizophrenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients aged of 40 and more with schizophrenia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female\n* aged of 40 and more\n* with schizophrenia\n* agreeing to participate in the study'}, 'identificationModule': {'nctId': 'NCT05174533', 'acronym': 'SCHIZO-CV', 'briefTitle': 'Prevalence of Cardiovascular Disorders in Patients Aged 40 and More With Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Université de Reims Champagne-Ardenne'}, 'officialTitle': 'Prevalence of Cardiovascular Disorders in Patients Aged 40 and More With Schizophrenia', 'orgStudyIdInfo': {'id': '2021-011-SCHIZO-CV'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'with schizophrenia', 'description': '"with schizophrenia" group : patients aged 40 and more with schizophrenia', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'electrocardiogram', 'armGroupLabels': ['with schizophrenia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02320', 'city': 'Prémontré', 'state': 'Grand Est', 'status': 'RECRUITING', 'country': 'France', 'facility': "Epsmd de l'Aisne"}], 'centralContacts': [{'name': 'CURRS Université de Reims Champagne-Ardenne', 'role': 'CONTACT', 'email': 'currs@univ-reims.fr', 'phone': '0326918822', 'phoneExt': '+33'}, {'name': 'Coralie BARBE, MD', 'role': 'CONTACT', 'email': 'currs@univ-reims.fr', 'phone': '0326918822', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Reims Champagne-Ardenne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}