Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-01-29 @ 7:59 AM
Study NCT ID:
NCT00846469
Status:
COMPLETED
Last Update Posted:
2012-12-05
First Post:
2009-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coronary Computed Tomography (CT) Angiography Versus Standard Therapy in the Emergency Room
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-04', 'studyFirstSubmitDate': '2009-02-17', 'studyFirstSubmitQcDate': '2009-02-17', 'lastUpdatePostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the usefulness of CCTA (coronary computed tomography angiography)in the emergency room setting to diagnose/predict the outcome of patients w/chest pain who have low to moderate risk of heart disease.', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'To determine if the use of CCTA (coronary computed tomography angiography)is more cost effective than the current standard of care treatments being used.', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chest Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the usefulness of CCTA (Coronary Computed Tomography Angiography) in the emergency room setting to diagnose and predict the outcome of patients with chest pain who have a low to moderate risk of heart disease.\n\nAnd to also determine if the use of CCTA(Coronary Computed Tomography Angiography) is more cost effective (cost less) than the current standards of care treatments. To determine if patients who present to the emergency room w/low to moderate probability of having an ACS (Acute Coronary Syndrome) prefer CCTA (coronary computed tomography angiography)-based care compared to standard algorithm based care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 25 years of age or older\n* Experiencing chest pain\n\nExclusion Criteria:\n\n* Pregnant\n* At high risk for ACS (Acute Coronary Syndrome)'}, 'identificationModule': {'nctId': 'NCT00846469', 'briefTitle': 'Coronary Computed Tomography (CT) Angiography Versus Standard Therapy in the Emergency Room', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': '64 Slice Coronary CT Angiography vs. Standard Therapy in the Emergency Room: Determining Cost-effectiveness and Predicting Clinical Outcome in Patients With Low and Moderate Risk for Acute Coronary Syndrome.', 'orgStudyIdInfo': {'id': 'HUM 0000 7282'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'chest pain', 'description': 'CCTA (Coronary computed tomography angiography)', 'interventionNames': ['Procedure: CCTA (coronary computed tomography angiography)', 'Other: Control section']}], 'interventions': [{'name': 'CCTA (coronary computed tomography angiography)', 'type': 'PROCEDURE', 'description': 'A CCTA (coronary computed tomography angiography) scan is a CT scan of the blood vessels of the heart. This CCTA (Coronary Computed Tomography Angiography)will be performed and a contrast medication will be injected through an IV line to help make the CT pictures more clear. Medication may or may not be given to control your heart rate during the scan. After the scan is completed it will be read. Your emergency room physician will use the CT results to determine your treatment.', 'armGroupLabels': ['chest pain']}, {'name': 'Control section', 'type': 'OTHER', 'description': 'Normal emergency room treatment for symptoms of chest pain.', 'armGroupLabels': ['chest pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Hospital', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Suzanne Chong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Suzanne Chong, MD', 'investigatorAffiliation': 'University of Michigan'}}}}