Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT00273832
Status:
COMPLETED
Last Update Posted:
2006-01-09
First Post:
2006-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Coronary Artery Computed Tomography to Diagnose Emergency Chest Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-12', 'completionDateStruct': {'date': '2005-11'}, 'lastUpdateSubmitDate': '2006-01-04', 'studyFirstSubmitDate': '2006-01-04', 'studyFirstSubmitQcDate': '2006-01-04', 'lastUpdatePostDateStruct': {'date': '2006-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of stay'}, {'measure': 'Cost of care'}], 'secondaryOutcomes': [{'measure': 'Unstable angina within 90-days'}, {'measure': 'Acute myocardial infarction within 90-days'}, {'measure': 'Cardiac death within 90-days'}]}, 'conditionsModule': {'keywords': ['Chest pain', 'Angina pectoris', 'Emergency medicine', 'Spiral computed tomography', 'Length of stay', 'Cost analysis'], 'conditions': ['Chest Pain', 'Angina Pectoris', 'Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '9862943', 'type': 'BACKGROUND', 'citation': 'Farkouh ME, Smars PA, Reeder GS, Zinsmeister AR, Evans RW, Meloy TD, Kopecky SL, Allen M, Allison TG, Gibbons RJ, Gabriel SE. A clinical trial of a chest-pain observation unit for patients with unstable angina. Chest Pain Evaluation in the Emergency Room (CHEER) Investigators. N Engl J Med. 1998 Dec 24;339(26):1882-8. doi: 10.1056/NEJM199812243392603.'}, {'pmid': '12383588', 'type': 'BACKGROUND', 'citation': 'Braunwald E, Antman EM, Beasley JW, Califf RM, Cheitlin MD, Hochman JS, Jones RH, Kereiakes D, Kupersmith J, Levin TN, Pepine CJ, Schaeffer JW, Smith EE 3rd, Steward DE, Theroux P, Gibbons RJ, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Hiratzka LF, Jacobs AK, Smith SC Jr; American College of Cardiology; American Heart Association. Committee on the Management of Patients With Unstable Angina. ACC/AHA 2002 guideline update for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction--summary article: a report of the American College of Cardiology/American Heart Association task force on practice guidelines (Committee on the Management of Patients With Unstable Angina). J Am Coll Cardiol. 2002 Oct 2;40(7):1366-74. doi: 10.1016/s0735-1097(02)02336-7. No abstract available.'}, {'pmid': '16053973', 'type': 'BACKGROUND', 'citation': "Raff GL, Gallagher MJ, O'Neill WW, Goldstein JA. Diagnostic accuracy of noninvasive coronary angiography using 64-slice spiral computed tomography. J Am Coll Cardiol. 2005 Aug 2;46(3):552-7. doi: 10.1016/j.jacc.2005.05.056."}, {'pmid': '9631967', 'type': 'BACKGROUND', 'citation': 'Zalenski RJ, Rydman RJ, Ting S, Kampe L, Selker HP. A national survey of emergency department chest pain centers in the United States. Am J Cardiol. 1998 Jun 1;81(11):1305-9. doi: 10.1016/s0002-9149(98)00159-3.'}, {'pmid': '17320744', 'type': 'DERIVED', 'citation': "Goldstein JA, Gallagher MJ, O'Neill WW, Ross MA, O'Neil BJ, Raff GL. A randomized controlled trial of multi-slice coronary computed tomography for evaluation of acute chest pain. J Am Coll Cardiol. 2007 Feb 27;49(8):863-71. doi: 10.1016/j.jacc.2006.08.064. Epub 2007 Feb 12."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether coronary artery computed tomography scanning is a more rapid, less expensive and safe alternative to standard diagnostic evaluation of patients with acute chest pain in the emergency room.', 'detailedDescription': 'Over 6 million patients per year visit hospital emergency departments for evaluation of chest pain, with diagnostic costs estimated to be in excess of $10 billion. Standard diagnostic evaluation often includes 8-12 hours of serial laboratory tests followed by stress imaging studies requiring an additional 4-8 hours.\n\nMulti-slice coronary artery computed tomography scanning (MSCT) has been shown to be a highly accurate diagnostic method in comparison to invasive angiography. Because of its speed and high negative predictive value, MSCT could rapidly screen patients for the presence of coronary disease, which may expedite their care.\n\nThis study compares the length of stay and cost of care in emergency chest pain patients randomly assigned to initial evaluation by MSCT compared to patients randomly assigned to a standard diagnostic evaluation including single photon emission computed tomography scanning. The study follows these patients to detect major adverse cardiac events including unstable angina, acute myocardial infarction or death over a 90-day period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chest pain or angina equivalent symptoms.\n* Age ≥ 25 years.\n* Low risk of infarction and/or complications by Goldman/Reilly criteria.\n\nExclusion Criteria:\n\n* Known coronary artery disease.\n* Electrocardiogram diagnostic of acute cardiac ischemia and/or infarction.\n* Elevated serum biomarkers including creatine kinase (CK) MB, myoglobin, and/or cardiac troponin I on initial testing.\n* Contraindication to iodinated contrast and/or beta blocking drugs.\n* Atrial fibrillation or markedly irregular rhythm.\n* Pregnancy.\n* Renal insufficiency, creatinine \\> 1.5 mg/dL.\n* Iodinated contrast within prior 48 hours.'}, 'identificationModule': {'nctId': 'NCT00273832', 'briefTitle': 'Study of Coronary Artery Computed Tomography to Diagnose Emergency Chest Pain', 'organization': {'class': 'OTHER', 'fullName': 'Corewell Health East'}, 'officialTitle': 'Randomized Controlled Trial of Multi-Slice Coronary Computed Tomography for Evaluation of Acute Chest Pain', 'orgStudyIdInfo': {'id': 'HIC - 2005 - 010'}}, 'armsInterventionsModule': {'interventions': [{'name': 'coronary artery computed tomography angiogram', 'type': 'PROCEDURE'}, {'name': 'single photon emission computed tomography', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}], 'overallOfficials': [{'name': 'Gilbert L Raff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corewell Health East'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corewell Health East', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Minestrelli Advanced Cardiac Research Imaging Center, Royal Oak, Michigan', 'class': 'UNKNOWN'}]}}}