Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT00705458
Status:
COMPLETED
Last Update Posted:
2015-08-25
First Post:
2008-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Comparing CT Scan and Stress Test in Diagnosing Coronary Artery Disease in Patients Hospitalized for Chest Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D000789', 'term': 'Angina, Unstable'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], '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'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}, {'id': 'D017256', 'term': 'Technetium Tc 99m Sestamibi'}, {'id': 'D013793', 'term': 'Thallium'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D015609', 'term': 'Organotechnetium Compounds'}, {'id': 'D009942', 'term': 'Organometallic Compounds'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-21', 'studyFirstSubmitDate': '2008-06-24', 'studyFirstSubmitQcDate': '2008-06-24', 'lastUpdatePostDateStruct': {'date': '2015-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coronary catheterization that does not lead to re-vascularization', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Length of Hospital Stay (time to discharge)', 'timeFrame': 'usually from hours to a few days (average about one day)'}, {'measure': 'Non-fatal myocardial infarction', 'timeFrame': '1 year'}, {'measure': 'Death (all cause)', 'timeFrame': '1 year'}, {'measure': 'Post-test renal dysfunction', 'timeFrame': 'usually within a few days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stress myocardial perfusion imaging', 'coronary computed tomography angiography'], 'conditions': ['Coronary Artery Disease', 'Angina Pectoris', 'Unstable Angina', 'Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '19577217', 'type': 'BACKGROUND', 'citation': 'Levsky JM, Travin MI, Spevack DM, Menegus MA, Huang PW, Goldberg Y, Clark ET, Banoth P, Freeman KD, Tobin JN, Haramati LB. Rationale and design of a randomized controlled trial comparing stress myocardial perfusion imaging with coronary CT angiography as the initial imaging study for intermediate-risk patients admitted with chest pain. J Cardiovasc Comput Tomogr. 2009 Jul-Aug;3(4):264-71. doi: 10.1016/j.jcct.2009.05.006. Epub 2009 May 21.'}, {'pmid': '26052677', 'type': 'RESULT', 'citation': 'Levsky JM, Spevack DM, Travin MI, Menegus MA, Huang PW, Clark ET, Kim CW, Hirschhorn E, Freeman KD, Tobin JN, Haramati LB. Coronary Computed Tomography Angiography Versus Radionuclide Myocardial Perfusion Imaging in Patients With Chest Pain Admitted to Telemetry: A Randomized Trial. Ann Intern Med. 2015 Aug 4;163(3):174-83. doi: 10.7326/M14-2948.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether coronary artery CT scanning or nuclear stress testing is better at diagnosing chest pain patients with coronary artery disease to select appropriate candidates for coronary catheterization and re-vascularization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient admitted for chest pain or pressure\n* patient at intermediate short term risk of MI or death (AHA/ACC guidelines)\n\nExclusion Criteria:\n\n* prior diagnosis of coronary artery disease\n* evidence of ongoing myocardial infarction (and other high risk criteria per AHA/ACC guidelines)\n* contraindications to EKG-gated CT scanning with iodinated intravenous contrast under beta-blockade\n* pregnancy\n* presence of an implanted pacemaker or defibrillator\n* stress myocardial perfusion imaging, coronary CTA or coronary catheterization within the last 6 months'}, 'identificationModule': {'nctId': 'NCT00705458', 'acronym': 'PROSPECT', 'briefTitle': 'Study Comparing CT Scan and Stress Test in Diagnosing Coronary Artery Disease in Patients Hospitalized for Chest Pain', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'A Randomized Trial Comparing Multi-Detector Coronary CT Angiography and Stress Myocardial Perfusion Imaging as the Initial Test for the Diagnosis of Coronary Artery Disease in Intermediate Risk Patients Admitted for Chest Pain', 'orgStudyIdInfo': {'id': 'MMC-07-07-197'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CTA', 'description': 'Initial EKG-gated computed tomography angiography of the coronary arteries', 'interventionNames': ['Procedure: Coronary Computed Tomography Angiography']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MPI', 'description': 'Initial nuclear stress myocardial perfusion imaging', 'interventionNames': ['Procedure: Stress Nuclear Myocardial Perfusion Imaging']}], 'interventions': [{'name': 'Coronary Computed Tomography Angiography', 'type': 'PROCEDURE', 'otherNames': ['CCTA', 'Coronary CT', 'Coronary CTA', 'Coronary Artery CT', 'Coronary Artery CTA', 'Coronary CT Angiography', 'CTA of the Coronary Arteries'], 'description': '64-detector, retrospectively EKG-gated, computed tomography angiography of the coronary arteries during heart rate control (intravenous metoprolol, when necessary)', 'armGroupLabels': ['CTA']}, {'name': 'Stress Nuclear Myocardial Perfusion Imaging', 'type': 'PROCEDURE', 'otherNames': ['stress test', 'nuclear stress test', 'dual-isotope stress test', 'sestamibi', 'thallium', 'myocardial perfusion imaging', 'nuclear perfusion imaging', 'gated SPECT', 'nuclear cardiology'], 'description': 'Usually dual-isotope perfusion imaging at rest (201-Thallium) and at stress (99m-Technetium-MIBI). Some patients will have a 2-day MIBI protocol. Gated SPECT and attenuation-correction images will be obtained. Treadmill stress will be performed. If a patient is unable to exercise, adenosine or dobutamine will be given.', 'armGroupLabels': ['MPI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Moses Division, Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Linda B Haramati, MD, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Montefiore Medical Center/Albert Einstein College of Medicine'}, {'name': 'Jeffrey M Levsky, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center/Albert Einstein College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Heart Association', 'class': 'OTHER'}, {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Director of Research', 'investigatorFullName': 'Jeffrey Levsky', 'investigatorAffiliation': 'Montefiore Medical Center'}}}}