Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-02-11 @ 4:37 AM
Study NCT ID:
NCT03058120
Status:
COMPLETED
Last Update Posted:
2017-02-20
First Post:
2017-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Henry Ford Heart Score Randomized Trial: Rapid Discharge of Patients Evaluated for Possible Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2015-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-15', 'studyFirstSubmitDate': '2017-02-14', 'studyFirstSubmitQcDate': '2017-02-15', 'lastUpdatePostDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cost of hospitalization', 'timeFrame': '30 days', 'description': 'Total charges accrued during index hospitalization, as well as costs related to index hospitalization up to 30 days after index discharge'}, {'measure': 'Length of stay', 'timeFrame': 'up to 1 week', 'description': 'Total length of stay of index hospitalization'}], 'secondaryOutcomes': [{'measure': '30-day MACE', 'timeFrame': '30 days after index hospitalization', 'description': 'Death, non-fatal myocardial infarction, stroke'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chest Pain', 'Heart Attack', 'Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '28954802', 'type': 'DERIVED', 'citation': 'Frisoli TM, Nowak R, Evans KL, Harrison M, Alani M, Varghese S, Rahman M, Noll S, Flannery KR, Michaels A, Tabaku M, Jacobsen G, McCord J. Henry Ford HEART Score Randomized Trial: Rapid Discharge of Patients Evaluated for Possible Myocardial Infarction. Circ Cardiovasc Qual Outcomes. 2017 Oct;10(10):e003617. doi: 10.1161/CIRCOUTCOMES.117.003617.'}]}, 'descriptionModule': {'briefSummary': 'This was a prospective randomized, controlled trial designed to quantify the reduction in cost and length of stay of early discharge of emergency department patients evaluated for acute myocardial infarction, who are deemed to be low risk based on a modified HEART score (a score that incorporates troponin biomarker, ecg, patient characteristics, and physician clinical judgment).', 'detailedDescription': 'This was a prospective randomized, controlled trial conducted from February 2014 to May 2015 designed to quantify the reduction in cost and length of stay of early discharge of emergency department patients evaluated for acute myocardial infarction, in those deemed to be low risk based on a modified HEART score. Our study enrolled only those deemed low risk, as these are the patients we believe best served by utilization of the HEART score decision aid.\n\nA total of 105 patients evaluated for AMI in the ED with a modified HEART score ≤ 3 (which includes cardiac troponin I \\< 0.04 ng/ml at 0 and 3 hours) were randomized to immediate discharge (n = 53) vs management in an observation unit with stress testing (n = 52).\n\nThe primary endpoints were 30-day total cost and length of stay. Secondary endpoints were all-cause death, nonfatal AMI, rehospitalization for evaluation of possible AMI, and coronary revascularization at 30 days.\n\nThat such an early discharge strategy would decrease cost and length of stay is intuitively expected; our goal was to quantify such a reduction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients 21 years or older\n* patients who presented to the Emergency Department with symptoms suspicious for AMI.\n* patients for whom the ED physician's intention to send the patient to the observation unit for stress testing\n\nExclusion Criteria:\n\n* Cardiac Troponin I \\> 0.04 ng/mL at 0 or 3 hours\n* clinical presentation warranting admission\n* inability or unwillingness to consent\n* trauma as etiology of presenting symptoms."}, 'identificationModule': {'nctId': 'NCT03058120', 'briefTitle': 'Henry Ford Heart Score Randomized Trial: Rapid Discharge of Patients Evaluated for Possible Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'Henry Ford Heart Score Randomized Trial: Rapid Discharge of Patients Evaluated for Possible Myocardial Infarction', 'orgStudyIdInfo': {'id': 'IRB 8558'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Stress testing', 'description': 'Patient with chest pain, low risk by modified HEART score, undergoes whatever admission and stress testing plan is determined by ED and inheriting decision unit physicians.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Early discharge', 'description': 'Patient with chest pain, low risk by modified HEART score, is discharged from the emergency room without admission nor stress testing.', 'interventionNames': ['Other: Deferral of admission for stress test']}], 'interventions': [{'name': 'Deferral of admission for stress test', 'type': 'OTHER', 'description': 'Early discharge; admission and stress test are deferred.', 'armGroupLabels': ['Early discharge']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Member of Heart and Vascular Institute in the Division of Cardiology', 'investigatorFullName': 'Tiberio Frisoli', 'investigatorAffiliation': 'Henry Ford Health System'}}}}