Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-27 @ 11:18 PM
Study NCT ID:
NCT05873660
Status:
COMPLETED
Last Update Posted:
2024-07-11
First Post:
2023-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Characterize the Prevalence of Overweight and Obesity Among Patients With Established Cardiovascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5360}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-10', 'studyFirstSubmitDate': '2023-05-15', 'studyFirstSubmitQcDate': '2023-05-15', 'lastUpdatePostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overweight and obesity among patients with established CVD pooled across all countries', 'timeFrame': 'At the time of patient enrolment (Day 1/Visit 1)', 'description': '% of patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Overweight']}, 'descriptionModule': {'briefSummary': 'The purpose of this observational study is to measure how many people are overweight or obese amongst patients with a diagnosed cardiovascular disease (CVD). The study also aims to characterise the population including the presence of cardiovascular (CV) risk factors in a number of countries across the globe representing different geographies, ethnicities, as well as different healthcare systems.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of adults aged 18 years or older diagnosed with established cardiovascular disease (CVD) and are attending routine medical care or follow-up in a cardiology clinic.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).\n2. Adults, age above or equal to 18 years at the time of signing informed consent.\n3. Have established CVD and equal to or greater than 1 follow up appointment following an acute event from at least one of the following:\n\n * Prior myocardial infarction\n * Prior stroke (ischemic or haemorrhagic stroke)\n * Symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) below 85 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease\n\nExclusion Criteria:\n\n1. Previous participation in this study. Participation is defined as having given informed consent in this study\n2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation\n3. Patients with known congenital heart disease/malformation'}, 'identificationModule': {'nctId': 'NCT05873660', 'acronym': 'POETIC', 'briefTitle': 'A Study to Characterize the Prevalence of Overweight and Obesity Among Patients With Established Cardiovascular Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Multi-centre Cross-sectional Observational Study to Characterize the Prevalence of Overweight and Obesity Among Patients With Established Cardiovascular Disease', 'orgStudyIdInfo': {'id': 'DAS-7537'}, 'secondaryIdInfos': [{'id': 'U1111-1283-8551', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'People with established CVD', 'description': 'Adults diagnosed with established CVD, attending routine medical care or follow-up in a cardiology clinic.', 'interventionNames': ['Other: No treatment given']}], 'interventions': [{'name': 'No treatment given', 'type': 'OTHER', 'description': 'No treatment given', 'armGroupLabels': ['People with established CVD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08536', 'city': 'Plainsboro', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.33344, 'lon': -74.60043}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Ontario', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site'}, {'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Clinical Transparency (dept. 2834)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'http://novonordisk-trials.com', 'ipdSharing': 'YES', 'description': '"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}