Ignite Creation Date:
2025-12-24 @ 12:51 PM
Ignite Modification Date:
2025-12-24 @ 12:51 PM
Study NCT ID:
NCT02828761
Status:
WITHDRAWN
Last Update Posted:
2023-09-15
First Post:
2016-06-15
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Coronary Calcium Scoring Versus Standard Care for Emergency Department Chest Pain Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study never initiated and formally withdrawn with the IRB on 9/14/2023.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-09-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-14', 'studyFirstSubmitDate': '2016-06-15', 'studyFirstSubmitQcDate': '2016-07-07', 'lastUpdatePostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-09-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Subsequent Major Adverse Cardiovascular Events', 'timeFrame': 'minimum of 6 months', 'description': 'number of patients with death, non-fatal heart attack, non-fatal stroke, non-fatal cardiac arrest'}, {'measure': 'Repeat emergency department visits and hospitalizations', 'timeFrame': 'minimum of 6 months', 'description': 'number of patients with return visits to the emergency department and hospitalizations after the end of the recruitment visit'}, {'measure': 'Subsequent non-invasive cardiac imaging', 'timeFrame': 'minimum of 6 months', 'description': 'number of patients with subsequent stress testing and computed tomography of the heart'}, {'measure': 'Subsequent coronary catheterization', 'timeFrame': 'minimum of 6 months', 'description': 'number of patients with subsequent conventional angiography of the heart'}, {'measure': 'Subsequent percutaneous or surgical coronary revascularization', 'timeFrame': 'minimum of 6 months', 'description': 'number of patients with subsequent coronary angioplasty, coronary stenting and bypass surgery'}, {'measure': 'Total effective radiation dose', 'timeFrame': 'minimum of 6 months', 'description': 'effective radiation dose estimated for procedures involving ionizing radiation'}, {'measure': 'The number of patients reporting changes in aspirin pharmacotherapy', 'timeFrame': 'minimum of 6 months', 'description': 'patients with new prescriptions for or increased dose of aspirin'}, {'measure': 'The number of patients reporting changes in anti-lipid pharmacotherapy', 'timeFrame': 'minimum of 6 months', 'description': 'patients with new prescriptions for or increased dose of lipid lowering medication'}, {'measure': 'The number of patients reporting persistent chest pain on telephone questionnaire', 'timeFrame': 'minimum of 6 months', 'description': 'how many patients report continued chest pain symptoms at follow-up'}, {'measure': 'The number of patients with incidental findings due to imaging and the types of findings', 'timeFrame': 'minimum of 6 months', 'description': 'how many patients had incidental findings on their heart imaging scans'}], 'primaryOutcomes': [{'measure': 'Major Adverse Cardiovascular Events', 'timeFrame': '30 days', 'description': 'number of patients with death, non-fatal heart attack, non-fatal stroke, non-fatal cardiac arrest'}], 'secondaryOutcomes': [{'measure': 'Length of Stay', 'timeFrame': 'through completion of emergency department stay for each patient, an average of six hours and through completion of hospitalization, an average of two days', 'description': 'emergency department and inpatient'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['chest pain', 'calcium score', 'coronary calcium score', 'coronary calcium scoring', 'calcium scoring', 'cacs', 'ccs'], 'conditions': ['Chest Pain']}, 'descriptionModule': {'briefSummary': 'This research asks whether coronary calcium scoring, a non-invasive test based on computed tomography scanning, is a better way to diagnose chest pain patients than other currently used methods. Three of four patients will undergo calcium scoring and the remaining patients will receive standard care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* complaint of chest pain or pressure\n* intermediate risk by HEART score\n* clinical indication for non-invasive cardiac imaging\n* free of known coronary artery disease\n\nExclusion Criteria:\n\n* hemodynamic instability\n* electrocardiogram suggestive of acute ischemia or myocardial infarction\n* unremitting chest pain\n* serum troponin levels greater than three times the laboratory threshold\n* unable to give his/her own written, informed consent\n* pregnant women\n* weight \\> 182 kg\n* unable to lie supine for scan\n* coronary calcium score, coronary CTA or non-contrast thoracic CT within the last year and available for review\n* unable to comply with 30 day follow-up'}, 'identificationModule': {'nctId': 'NCT02828761', 'briefTitle': 'Coronary Calcium Scoring Versus Standard Care for Emergency Department Chest Pain Patients', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'A Randomized Controlled Trial of Early Coronary Calcium Scoring and Standard Care in Emergency Department Chest Pain Patients', 'orgStudyIdInfo': {'id': '2015-4993'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Coronary Calcium Scoring', 'description': 'Coronary calcium scoring by multidetector row computed tomography (MDCT).', 'interventionNames': ['Device: Coronary Calcium Scoring']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care', 'description': 'Standard evaluation of chest pain patient which often includes immediate non-invasive imaging.', 'interventionNames': ['Procedure: Standard Care']}], 'interventions': [{'name': 'Coronary Calcium Scoring', 'type': 'DEVICE', 'otherNames': ['Calcium Score', 'Calcium Scoring', 'Coronary Calcium Score', 'CACS', 'CCS'], 'description': 'Scan with 64-detector row or better CT scanners with quantification by the Agatston method.', 'armGroupLabels': ['Coronary Calcium Scoring']}, {'name': 'Standard Care', 'type': 'PROCEDURE', 'description': 'Routine clinical monitoring of chest pain patients. Any of a number of non-invasive cardiac tests such as coronary CT angiography, stress echocardiography and stress radionuclide myocardial perfusion imaging may be performed.', 'armGroupLabels': ['Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center - Einstein Division', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center - Wakefield Division', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Jeffrey M Levsky, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center/Albert Einstein College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}