Ignite Creation Date:
2025-12-24 @ 4:22 PM
Ignite Modification Date:
2026-02-03 @ 12:16 PM
Study NCT ID:
NCT06684366
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-12
First Post:
2024-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Coronary Syndrome Real Practice and Guidelines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}, {'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D019821', 'term': 'Simvastatin'}], 'ancestors': [{'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-10', 'studyFirstSubmitDate': '2024-10-24', 'studyFirstSubmitQcDate': '2024-11-10', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effect of revasculariztion strategies on chronic coronary syndrome patients', 'timeFrame': '6 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic coronary syndrome'], 'conditions': ['Coronary Arterial Disease (CAD)']}, 'descriptionModule': {'briefSummary': 'Evaluate Adherence to the 2019 ESC Guidelines and standard care protocols for managing patients with the chronic coronary syndrome within the center', 'detailedDescription': 'Coronary artery disease (CAD) refers to the presence of atherosclerotic plaques in the coronary arteries, Which can be non-obstructive or obstructive. It represents a major cause of morbidity, mortality, Hospitalization and health expenditure.\n\nThe most recent European Guidelines for the diagnosis and management of CCS delineate six common CCS scenarios: patients with suspected CAD and stable angina symptoms and/or dyspnea; patients with new onset of heart failure or left ventricular dysfunction and suspected CAD; asymptomatic and symptomatic patients with stabilized symptoms within one year after an acute coronary syndrome, or patients with recent revascularisation; asymptomatic and symptomatic patients beyond one year after initial diagnosis or revascularisation; Patients with angina and suspected vasospastic or microvascular disease; Asymptomatic subjects in whom CAD is detected at screening. Although these scenarios are heterogeneous, they are associated with an increased risk of acute events, and the stability of CCS patients over time depends on prompt diagnosis, optimal treatment and secondary prevention strategies, including Lifestyle modifications, and pharmacotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with angina and/or dyspnea, and suspected coronary artery disease. Patients with new onset of heart failure or reduced left ventricular function. Patients within 1 year after an acute coronary syndrome or recent revascularization.\n\nPatients beyond 1 year after initial diagnosis or revascularization. Patients with ANOCA (e.g., microvascular angina, vasospastic angina). Asymptomatic subjects referred for screening for coronary artery disease.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\nAdult patients (18 years or older) with a confirmed or suspected diagnosis of CCS, fall within one of the following broad CCS categories:\n\n* Patients with angina and/or dyspnea, and suspected coronary artery disease.\n* Patients with new onset of heart failure or reduced left ventricular function.\n* Patients within 1 year after an acute coronary syndrome or recent revascularization.\n* Patients beyond 1 year after initial diagnosis or revascularization.\n* Patients with ANOCA (e.g., microvascular angina, vasospastic angina).\n* Asymptomatic subjects referred for screening for coronary artery disease.\n\nExclusion Criteria:\n\n* Patients with a recent acute coronary syndrome (defined as those within 1 month of a diagnosis of unstable angina, non-ST-segment elevation myocardial infarction or ST-segment elevation myocardial infarction)'}, 'identificationModule': {'nctId': 'NCT06684366', 'briefTitle': 'Chronic Coronary Syndrome Real Practice and Guidelines', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Chronic Coronary Syndrome...real Practice and Guidelines...A Single Center Registery', 'orgStudyIdInfo': {'id': 'Chronic coronary Syndrome'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Statins (atorvastatin or simvastatin)', 'type': 'DRUG', 'description': 'A resting transthoracic echocardiogram Non-invasive functional imaging for myocardial ischemia or coronary computed tomography angiography (CCTA) is recommended as the initial test for diagnosing CAD in symptomatic patients in whom obstructive CAD cannot be excluded by clinical assessment alone'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Cardiology Department Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'residuent doctor', 'investigatorFullName': 'Samar Mohamed Gad Bayoumi', 'investigatorAffiliation': 'Assiut University'}}}}