Ignite Creation Date:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2025-12-31 @ 12:41 PM
Study NCT ID:
NCT01534000
Status:
COMPLETED
Last Update Posted:
2014-06-19
First Post:
2011-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac-CT in the Treatment of Acute Chest Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000241', 'term': 'Adenosine'}], 'ancestors': [{'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-18', 'studyFirstSubmitDate': '2011-12-22', 'studyFirstSubmitQcDate': '2012-02-15', 'lastUpdatePostDateStruct': {'date': '2014-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'combined endpoint of: Cardiac death, myocardial infarction, unstabile angina, revascularisation, readmissions for chest pain', 'timeFrame': '1 year follow-up'}], 'secondaryOutcomes': [{'measure': 'Cardiac death', 'timeFrame': '1 year follow-up'}, {'measure': 'myocardial infarction', 'timeFrame': '1 year follow-up'}, {'measure': 'readmissions for chest pain', 'timeFrame': '1 year follow-up'}, {'measure': 'Revascularisation', 'timeFrame': '1 year follow-up'}, {'measure': 'unstabile angina', 'timeFrame': '1-year follow-up'}, {'measure': 'continued chest pain', 'timeFrame': '1 year follow-up'}, {'measure': 'Quality of life (SF-36)', 'timeFrame': '1-year follow-up'}, {'measure': 'medication', 'timeFrame': '1-year follow-up'}, {'measure': 'non-cardiac findings on CT', 'timeFrame': '1-year follow-up'}, {'measure': 'downstream testing', 'timeFrame': '1-year follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiac CT', 'Ischemic heat disease', 'Stress test'], 'conditions': ['Ischemic Heart Disease']}, 'referencesModule': {'references': [{'pmid': '26577263', 'type': 'DERIVED', 'citation': 'Linde JJ, Hove JD, Sorgaard M, Kelbaek H, Jensen GB, Kuhl JT, Hindso L, Kober L, Nielsen WB, Kofoed KF. Long-Term Clinical Impact of Coronary CT Angiography in Patients With Recent Acute-Onset Chest Pain: The Randomized Controlled CATCH Trial. JACC Cardiovasc Imaging. 2015 Dec;8(12):1404-1413. doi: 10.1016/j.jcmg.2015.07.015. Epub 2015 Nov 11.'}]}, 'descriptionModule': {'briefSummary': 'Objectives The CATCH trial (CArdiac cT in the treatment of acute CHest pain) is a prospective randomized controlled trial designed to evaluate the clinical value of cardiac multidetector computed tomography (MDCT) as a first-line diagnostic strategy in patients with acute chest pain, compared to a conventional functional-based testing strategy.\n\nMethods:\n\nConsecutive patients admitted with acute chest pain of suspected cardiac origin, but normal electrocardiogram and biomarkers were randomized to evaluation with 320-MDCT coronary angiography (CT-guided group) or with standard bicycle exercise test and/or myocardial perfusion imaging - MPI (Control group).\n\nAfter one year, patients will be followed-up, with registration of clinical endpoints such as Cardiac death, myocardial infarction, need for revascularisation, admittance for heart related problems, sustained chest pain, live quality score, use of medication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Admittance because of Chest pain\n* Non- or non-diagnostic ecg-changes.\n* Normal biomarkers for ischemia (Troponins)\n* Chest X-ray without pathological findings associated with chest pain.\n\nExclusion Criteria:\n\n* Women of childbearing age, or \\> 40 years and using approved contraception.\n* Claustrophobia\n* Patients with geographical residence, that complicates follow-up\n* Patients with mental or physical conditions that impede follow-up\n* Increase in Troponins\n* New diagnostic ECG changes with ST-segment elevation or depression greater than 1mm or T-yew inversion\\> 4 mm in\\> 2 anatomically connected derivations.\n* Allergy to iodinated contrast agents\n* Serum creatinine greater than 130 mg/l\n* Abnormal chest x-ray or blood tests hospitalization as assessed as the main cause of the patient's pain problem."}, 'identificationModule': {'nctId': 'NCT01534000', 'acronym': 'CATCH', 'briefTitle': 'Cardiac-CT in the Treatment of Acute Chest Pain', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Cardiac-CT in the Treatment of Acute Chest Pain', 'orgStudyIdInfo': {'id': 'H-C-2009-053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CT guided group', 'description': 'For Patients with chest pain randomised to this arm, clinical decision will be based on the results of a Cardiac computed tomographic angiography (CCTA)', 'interventionNames': ['Procedure: Cardiac computed tomographic angiography (CCTA)']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients with chest pain randomised to the control group will be evaluated using the standard functional-based strategy with either a treadmill stress-test or SPECT (single-photon emission computed tomography). A Cardiac CT will will be performed, but will be blinded for initial clinical evaluation.'}], 'interventions': [{'name': 'Cardiac computed tomographic angiography (CCTA)', 'type': 'PROCEDURE', 'otherNames': ['Adenosin for CT myocardial perfusion'], 'description': 'Patients will (on top of the standard clinical evaluation with a functional-based stress-test) be examined with a Cardiac CT scan. In the control group, the Cardiac CT will be blinded for clinical evaluation and only used retrospectively for research purpose.', 'armGroupLabels': ['CT guided group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Hvidovre University Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'overallOfficials': [{'name': 'Jesper J Linde, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hvidovre University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Cardiac CT, MD,PHD', 'investigatorFullName': 'Jens D Hove, MD,PHD', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}