Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT05344612
Status:
RECRUITING
Last Update Posted:
2023-07-20
First Post:
2022-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing a Diagnostic and Treatment Strategy of Upfront CTCA With SOC in Patients With Chest Pain and Suspected CAD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002637', 'term': 'Chest Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6444}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-19', 'studyFirstSubmitDate': '2022-04-19', 'studyFirstSubmitQcDate': '2022-04-19', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of all-cause mortality and non-fatal myocardial infarction', 'timeFrame': '1 Year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chest Pain', 'CAD']}, 'descriptionModule': {'briefSummary': "Rationale:\n\nPatients with chest pain usually undergo multiple diagnostic examinations to demonstrate or rule out atherosclerotic coronary artery disease (CAD). In addition to high healthcare costs, some of the examinations do not assess the presence of CAD, which means that patients may be undertreated and are at risk for myocardial infarction. A uniform diagnostic and treatment strategy that uses computed tomography coronary angiography (CTCA) as initial examination may reduce major adverse cardiac events (MACE) and may reduce healthcare costs. In addition, we hypothesize that this strategy improves angina-related health status and reduces the number of invasive coronary angiograms (CAG's).\n\nObjectives:\n\n* To show that the intervention is non-inferior to the control with regards to clinical outcomes\n* To show superiority of the intervention with regards to clinical outcomes\n\nStudy design: National multicenter prospective randomized controlled trial.\n\nStudy population: Patients with suspected stable CAD.\n\nIntervention: upfront CTCA to diagnose CAD and guide optimal medical therapy (OMT). Patients with obstructive CAD and refractory angina despite OMT will undergo non-invasive ischemia imaging to guide revascularization.\n\nControl: Standard of care. Diagnosis and treatment are at the discretion of the attending cardiologist.\n\nMain study end point: Composite of all-cause mortality and non-fatal myocardial infarction."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years\n\nExclusion Criteria:\n\n* Presentation with acute coronary syndrome\n* Acute coronary syndrome within last 3 months\n* History of obstructive coronary artery disease on imaging\n* History of PCI and/or CABG\n* Severe renal failure\n* Severe allergy to ionidated contrast medium\n* Known pregnancy\n* Patients with an estimated life expectancy of less than 1 year'}, 'identificationModule': {'nctId': 'NCT05344612', 'acronym': 'CLEAR-CAD', 'briefTitle': 'Comparing a Diagnostic and Treatment Strategy of Upfront CTCA With SOC in Patients With Chest Pain and Suspected CAD', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Clinical Outcomes and Cost-effectiveness of a Diagnostic and Treatment Strategy of Upfront CTCA Plus Selective Non-invasive Functional Imaging Compared With Standard Care in Patients With Chest Pain and Suspected Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'NL81264.018.22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CTCA', 'interventionNames': ['Radiation: CT Coronary Angiography']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care'}], 'interventions': [{'name': 'CT Coronary Angiography', 'type': 'RADIATION', 'description': 'Upfront ct-coronary angiography', 'armGroupLabels': ['CTCA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105 AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'José PS Henriques, prof. dr.', 'role': 'CONTACT', 'email': 'j.p.s.henriques@amsterdamumc.nl', 'phone': '020-5665204'}, {'name': 'Casper F Coerkamp, MD', 'role': 'CONTACT', 'email': 'clearcad@amsterdamumc.nl', 'phone': '020-5665204'}], 'facility': 'Amsterdam UMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.Dr.', 'investigatorFullName': 'J.P.S Henriques', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}