Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-04-20 @ 1:15 PM
Study NCT ID:
NCT01868256
Status:
UNKNOWN
Last Update Posted:
2013-06-04
First Post:
2012-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Early Discharge Following Low Risk Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'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': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1558}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-05-30', 'studyFirstSubmitDate': '2012-11-23', 'studyFirstSubmitQcDate': '2013-05-30', 'lastUpdatePostDateStruct': {'date': '2013-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Difference in quality of life and functional capacity questionnaire SF-36.', 'timeFrame': '1 month'}, {'measure': 'Compliance of treatment', 'timeFrame': '1 month'}], 'primaryOutcomes': [{'measure': 'All cause mortality, new acute myocardial infarction, new unstable angina, heart failure, ventricular arrhythmias, stroke and severe bleeding.', 'timeFrame': '1 month', 'description': 'Composite primary end-point'}], 'secondaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': '1 month'}, {'measure': 'Myocardial infarction', 'timeFrame': '1 month'}, {'measure': 'Unstable angina', 'timeFrame': '1 month'}, {'measure': 'Heart failure', 'timeFrame': '1 month'}, {'measure': 'Ventricular arrhythmias', 'timeFrame': '1 month'}, {'measure': 'Stroke', 'timeFrame': '1 month'}, {'measure': 'Severe bleeding', 'timeFrame': '1 month', 'description': 'According to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['myocardial infarction', 'primary percutaneous intervention', 'prognosis', 'early discharge'], 'conditions': ['Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '10717009', 'type': 'BACKGROUND', 'citation': 'Newby LK, Eisenstein EL, Califf RM, Thompson TD, Nelson CL, Peterson ED, Armstrong PW, Van de Werf F, White HD, Topol EJ, Mark DB. Cost effectiveness of early discharge after uncomplicated acute myocardial infarction. N Engl J Med. 2000 Mar 16;342(11):749-55. doi: 10.1056/NEJM200003163421101.'}, {'pmid': '15159293', 'type': 'BACKGROUND', 'citation': "De Luca G, Suryapranata H, van 't Hof AW, de Boer MJ, Hoorntje JC, Dambrink JH, Gosselink AT, Ottervanger JP, Zijlstra F. Prognostic assessment of patients with acute myocardial infarction treated with primary angioplasty: implications for early discharge. Circulation. 2004 Jun 8;109(22):2737-43. doi: 10.1161/01.CIR.0000131765.73959.87. Epub 2004 May 24."}, {'pmid': '9561995', 'type': 'BACKGROUND', 'citation': "Grines CL, Marsalese DL, Brodie B, Griffin J, Donohue B, Costantini CR, Balestrini C, Stone G, Wharton T, Esente P, Spain M, Moses J, Nobuyoshi M, Ayres M, Jones D, Mason D, Sachs D, Grines LL, O'Neill W. Safety and cost-effectiveness of early discharge after primary angioplasty in low risk patients with acute myocardial infarction. PAMI-II Investigators. Primary Angioplasty in Myocardial Infarction. J Am Coll Cardiol. 1998 Apr;31(5):967-72. doi: 10.1016/s0735-1097(98)00031-x."}, {'pmid': '20102876', 'type': 'BACKGROUND', 'citation': 'Kotowycz MA, Cosman TL, Tartaglia C, Afzal R, Syal RP, Natarajan MK. Safety and feasibility of early hospital discharge in ST-segment elevation myocardial infarction--a prospective and randomized trial in low-risk primary percutaneous coronary intervention patients (the Safe-Depart Trial). Am Heart J. 2010 Jan;159(1):117.e1-6. doi: 10.1016/j.ahj.2009.10.024.'}]}, 'descriptionModule': {'briefSummary': "* Objectives: The primary objective of this study is to evaluate the safety of an early discharge strategy in patients with low risk ST-elevation myocardial infarction (STEMI), treated with primary percutaneous coronary intervention (PPCI), compared to a conventional strategy.\n* Methodology: Unicentric, randomized, controlled, non-inferiority and open label clinical trial. The investigators will compare an early discharge strategy (≤72 hours) with a conventional strategy (discharge according to treating physician's criterion). Inclusion criteria will be: low risk (Zwolle risk score ≤3) STEMI treated with PPCI within 24 hours from symptoms onset. Exclusion criteria will be: arrhythmias (ventricular tachycardia or fibrillation, asystole, pulseless electrical activity, advanced atrio-ventricular block), mechanical complications (cardiac tamponade, free-wall or septal rupture, acute mitral regurgitation, pericarditis), severe or moderate bleeding (according to the GUSTO criteria), complications related to vascular access of the procedure, acute kidney failure, infection, heart failure. Sample size will be 1558 subjects (n=779 per group). The investigators will study demographic, clinical, biochemical, echocardiographic and angiographic variables. The primary endpoint will be a composite of death, reinfarction, new angina, heart failure, ventricular arrhythmias, stroke and severe bleeding. The secondary endpoint will include each of the items of the primary endpoint and quality of life and functional capacity questionnaire SF-36. Finally, the investigators will analyze the degree of compliance with the European Society of Cardiology guidelines on STEMI and the rate of hospitalization-related complications. Follow up will be at 30 days."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* low risk (Zwolle risk score ≤3) STEMI treated with PPCI within 24 hours from symptoms onset\n* Informed consent\n\nExclusion Criteria:\n\n* arrhythmias (ventricular tachycardia or fibrillation, asystole, pulseless electrical activity, advanced atrio-ventricular block)\n* mechanical complications (cardiac tamponade, free-wall or septal rupture, acute mitral regurgitation, pericarditis)\n* severe or moderate bleeding (according to the GUSTO criteria)\n* complications related to vascular access of the procedure\n* acute kidney failure\n* infection\n* heart failure'}, 'identificationModule': {'nctId': 'NCT01868256', 'acronym': 'EDAMI', 'briefTitle': 'Safety of Early Discharge Following Low Risk Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Safety of a Early Discharge Strategy in Patients With Low-risk ST-segment Elevation Myocardial Infarction Treated With Primary Coronary Intervention: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IIBSP-PAP-2011-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early discharge (< 72 h)', 'description': 'Patients randomized the early discharge group will be discharged from the hospital in \\< 72 hours', 'interventionNames': ['Other: early discharge (<72 h)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional discharge', 'description': 'Patients randomized to the conventional discharge group will be discharged according to the local hospital protocol and/or treating physician criterion', 'interventionNames': ['Other: Conventional discharge']}], 'interventions': [{'name': 'early discharge (<72 h)', 'type': 'OTHER', 'armGroupLabels': ['Early discharge (< 72 h)']}, {'name': 'Conventional discharge', 'type': 'OTHER', 'armGroupLabels': ['Conventional discharge']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Alessandro Sionis, MD', 'role': 'CONTACT', 'email': 'asionis@santpau.cat', 'phone': '+ 34 935565945'}, {'name': 'Alessandro Sionis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Alessandro Sionis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}