Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-02-26 @ 2:18 AM
Study NCT ID:
NCT03781492
Status:
RECRUITING
Last Update Posted:
2020-05-26
First Post:
2018-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stable Angina Management and Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-21', 'studyFirstSubmitDate': '2018-12-18', 'studyFirstSubmitQcDate': '2018-12-18', 'lastUpdatePostDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with reported deaths from any cause', 'timeFrame': 'From date of inclusion until the date of death from any cause, assessed up to 5 year'}], 'secondaryOutcomes': [{'measure': 'Number of participants with reported myocardial infarction', 'timeFrame': 'From date of inclusion until the date of first event, assessed up to 5 year'}, {'measure': 'Number of participants with reported cerebrovascular insult', 'timeFrame': 'From date of inclusion until the date of first event, assessed up to 5 year'}, {'measure': 'Number of participants with reported acute coronary syndrome driven revascularisation', 'timeFrame': 'From date of inclusion until the date of first event, assessed up to 5 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stable Angina', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The Prospective REgistry of Stable Angina manaGEment and Treatment (PRESAGE) is an observational study on an all-comer stable angina population hospitalised in a highly specialized cardiovascular centre with cardiac surgery facilities. The aim of the study is to assess the clinical characteristics, treatment modalities, early and long-term outcomes in this population.', 'detailedDescription': 'The Prospective REgistry of Stable Angina manaGEment and Treatment (PRESAGE) is a single-center, observational study recruiting consecutive patients with stable angina, who were diagnosed and treated in the 3rd Chair and Department of Cardiology in the Silesian Centre for Heart Diseases in Zabrze, Poland. The Silesian Centre for Heart Diseases is a highly specialised cardiology centre with cardiac surgery facilities\n\nThe main objective of the PRESAGE Registry is to clarify the overall clinical characteristics of patients with stable angina, their demographics and clinical profile, current management, early and long-term outcomes, with regard to the administered treatment.\n\nThe diagnosis of stable angina was based on clinical characterization, coronary angiography, and the current guidelines of the European Society of Cardiology. Patients with vasospastic and/or microvascular angina were also included to the registry. Performance of coronary angiography is the criterion of the enrolment in the registry.\n\nPatients with acute coronary syndromes are excluded from the analysis.\n\nData collection is patient-based (not event-based).\n\nComplete patient demographics: medical history, complete hospitalization data (diagnostic and therapeutic) and in-hospital results are collected in an electronic form by the attending physician. The patients are under constant follow-up for all-cause mortality and major cardiac adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is formed by all-comer patients hospitalized in cardiology ward with a diagnosis of stable angina.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* symptom based diagnosis of stable angina\n\nExclusion Criteria:\n\n* acute coronary syndrome on admission\n* ≤ 18 years old'}, 'identificationModule': {'nctId': 'NCT03781492', 'acronym': 'PRESAGE', 'briefTitle': 'Stable Angina Management and Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Silesian Centre for Heart Diseases'}, 'officialTitle': 'Prospective REgistry of Stable Angina manaGEment and Treatment', 'orgStudyIdInfo': {'id': 'PRESAGE Registry'}}, 'contactsLocationsModule': {'locations': [{'zip': '41-800', 'city': 'Zabrze', 'state': 'Silesian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Mariusz Gąsior, Prof, MD, PhD', 'role': 'CONTACT'}], 'facility': '3rd Chair and Department of Cardiology of Silesian Centre for Heart Diseases', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}], 'centralContacts': [{'name': 'Piotr Desperak, MD', 'role': 'CONTACT', 'email': 'desperak.piotr@gmail.com', 'phone': '+48514374167'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Silesian Centre for Heart Diseases', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Mariusz Gasior', 'investigatorAffiliation': 'Silesian Centre for Heart Diseases'}}}}