Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-01-23 @ 1:51 AM
Study NCT ID:
NCT02591992
Status:
UNKNOWN
Last Update Posted:
2016-02-18
First Post:
2015-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computed Tomography as the First-Choice Diagnostics in High Pre-Test Probability of Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-17', 'studyFirstSubmitDate': '2015-10-27', 'studyFirstSubmitQcDate': '2015-10-29', 'lastUpdatePostDateStruct': {'date': '2016-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The volume of contrast agent used for diagnosis and possible coronary intervention in the arm: A. Angio-CT versus B. Classic diagnostics (non-inferiority)', 'timeFrame': 'up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry).', 'description': 'safety co-primary outcome'}, {'measure': 'The radiation dose used for diagnosis of coronary artery disease and possible intervention in the arm: A. Angio-CT versus B. Classic diagnostics (non-inferiority)', 'timeFrame': 'up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry).', 'description': 'safety co-primary outcome'}], 'primaryOutcomes': [{'measure': 'The average number of invasive procedures (coronary angiography/PCI) in the arm: A. Angio - CT versus B. Classic diagnostics (superiority)', 'timeFrame': 'up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry).'}, {'measure': 'The proportion of "avoidable" invasive diagnostic procedures (coronary angiographies not followed by an intervention) in the arm: A. Angio-CT versus B. Classic diagnostics (superiority)', 'timeFrame': 'up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry).'}, {'measure': 'Composite outcome of: myocardial infarction, death, acute coronary syndrome, unplanned coronary revascularization, hospitalization for cardiovascular reason, stroke', 'timeFrame': 'up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry).'}], 'secondaryOutcomes': [{'measure': 'composite outcome: number of serious adverse events during diagnosis and treatment of coronary artery disease', 'timeFrame': 'up to 36 months (through study completion)', 'description': 'composite of: - death,\n\n* acute coronary syndrome,\n* urgent hospitalization for cardiovascular causes,\n* stroke,\n* unplanned PCI as a treatment of invasive coronary angiography complications,\n* urgent CABG surgery as a result of PCI or coronary angiography complications,\n* surgical treatment of local vascular complications or with blood products,\n* hospitalization or prolongation of hospitalization due to local vascular complications,\n* the occurrence of a pseudoaneurysm, fistula, or occlusion in the vascular access site,\n* decrease in renal function (a fall of at least one stage of chronic kidney disease),\n* 2-5 type bleeding defined by " Bleeding Academic Research Consortium",\n* life threat, need for hospitalization or its prolongation, durable or substantial health damage.'}, {'measure': 'Time to occurrence of composite outcome of: myocardial infarction, death, acute coronary syndrome, unplanned coronary revascularization (including restenosis), urgent hospitalization for cardiovascular reason, stroke', 'timeFrame': 'up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry).'}, {'measure': 'Time to occurrence of composite outcome of: myocardial infarction, death, acute coronary syndrome, unplanned coronary revascularization (including restenosis), urgent hospitalization for cardiovascular reason, stroke', 'timeFrame': 'up to 36 months (through study completion)'}, {'measure': 'Number of angioplasty procedures performed in accordance with ESC recommendations where the treatment planned on the basis of CT angiography by an interventional cardiologist is not treated ad-hoc.', 'timeFrame': 'up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry).'}, {'measure': 'Average number of therapeutic procedures (PCI/CABG).', 'timeFrame': 'up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry).'}, {'measure': 'Average time to complete diagnostic and therapeutic cycle (from the first examination of the coronary arteries to termination or disqualification from the surgical treatment).', 'timeFrame': 'up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry).'}, {'measure': 'Average consumption of resources (comparison of coronary artery disease diagnosis and treatment costs in accordance to National Health Service and Institute of Cardiology price lists.', 'timeFrame': 'up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry).'}, {'measure': 'Average number of days of hospitalization required to complete the diagnostic and therapeutic cycle.', 'timeFrame': 'up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '30201310', 'type': 'DERIVED', 'citation': 'Rudzinski PN, Kruk M, Kepka C, Schoepf UJ, Duguay T, Dzielinska Z, Pregowski J, Witkowski A, Ruzyllo W, Demkow M. The value of Coronary Artery computed Tomography as the first-line anatomical test for stable patients with indications for invasive angiography due to suspected Coronary Artery Disease: CAT-CAD randomized trial. J Cardiovasc Comput Tomogr. 2018 Nov-Dec;12(6):472-479. doi: 10.1016/j.jcct.2018.08.004. Epub 2018 Sep 4.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and effectiveness of computed tomography angiography in the diagnostic and therapeutic cycle as the first-choice method of imaging in the diagnosis of patients with a high probability of stable coronary artery disease according to European Society of Cardiology recommendations.', 'detailedDescription': 'A prospective, randomized open-label, single center trial to evaluate superiority of angio-CT to a classic coronary angiography (concerning effectiveness and safety) in the diagnosis of stable coronary artery disease in patients with indications for invasive coronary angiography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\>18 years\n2. Patients providing written informed consent\n3. Indications for elective invasive coronary angiography defined by European Society of Cardiology as:\n\n * Left ventricle ejection fraction \\<50% and typical angina symptoms,\n * Probability of coronary artery disease due to criteria of age, sex and symptoms \\>85%, or\n * Probability of coronary artery disease due to criteria of age, sex and symptoms 50-85% with positive or moderate cardiac stress test.\n\nExclusion Criteria:\n\n1. No Consent to the study\n2. Acute coronary syndrome\n3. Recurrence of typical angina symptoms 1 year after the last percutaneous coronary revascularization,\n4. Contraindications to invasive coronary angiography\n5. GFR \\<60 ml/min/1.73m2\n6. Significant arrhythmia\n7. BMI \\>35 kg/m2'}, 'identificationModule': {'nctId': 'NCT02591992', 'acronym': 'CAT-CAD', 'briefTitle': 'Computed Tomography as the First-Choice Diagnostics in High Pre-Test Probability of Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'National Institute of Cardiology, Warsaw, Poland'}, 'officialTitle': 'Coronary Artery Computed Tomography as the First-Choice Imaging Diagnostics in Patients With High Pre-Test Probability of Coronary Artery Disease', 'orgStudyIdInfo': {'id': '2.13/III/15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cardiac CT', 'description': '60 patients with high pre-test probability o coronary artery disease will be randomly chosen and undergo computed tomography angiography (cardiac CT) as the first-choice imaging diagnostics', 'interventionNames': ['Other: Cardiac CT as the first diagnostic modality in suspected CAD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Invasive coronary angiography', 'description': '60 patients with high pre-test probability o coronary artery disease will be randomly chosen and undergo invasive coronary angiography', 'interventionNames': ['Other: Invasive coronary angiography as indicated by the guidelines']}], 'interventions': [{'name': 'Cardiac CT as the first diagnostic modality in suspected CAD', 'type': 'OTHER', 'description': 'Performation of non-invasive cardiac CT angiogram', 'armGroupLabels': ['Cardiac CT']}, {'name': 'Invasive coronary angiography as indicated by the guidelines', 'type': 'OTHER', 'description': 'Patient undergoes invasive coronary angiography', 'armGroupLabels': ['Invasive coronary angiography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04-628', 'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Institute of Cardiology', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Piotr N Rudziński, M.D.', 'role': 'CONTACT', 'email': 'piotr.rudzinski@ikard.pl', 'phone': '+48608499737'}, {'name': 'Mariusz Kruk, Prof.', 'role': 'CONTACT', 'email': 'mkruk@ikard.pl', 'phone': '+48223434342'}], 'overallOfficials': [{'name': 'Mariusz Kruk, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'National Institute of Cardiology, Warsaw, Poland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Cardiology, Warsaw, Poland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}