Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-01 @ 9:14 AM
Study NCT ID:
NCT00769366
Status:
COMPLETED
Last Update Posted:
2017-05-02
First Post:
2008-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized, Controlled Study on Short-term Psychotherapy After Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}], 'ancestors': [{'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-28', 'studyFirstSubmitDate': '2008-10-07', 'studyFirstSubmitQcDate': '2008-10-07', 'lastUpdatePostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The cumulative incidence of new cardiological events and the occurrence of new medical pathologies', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Incidence of re-hospitalisations', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '30659815', 'type': 'DERIVED', 'citation': 'Pristipino C, Roncella A, Pasceri V, Speciale G. Short-TErm Psychotherapy IN Acute Myocardial Infarction (STEP-IN-AMI) Trial: Final Results. Am J Med. 2019 May;132(5):639-646.e5. doi: 10.1016/j.amjmed.2018.12.025. Epub 2019 Jan 17.'}, {'pmid': '24239154', 'type': 'DERIVED', 'citation': 'Roncella A, Pristipino C, Cianfrocca C, Scorza S, Pasceri V, Pelliccia F, Denollet J, Pedersen SS, Speciale G. One-year results of the randomized, controlled, short-term psychotherapy in acute myocardial infarction (STEP-IN-AMI) trial. Int J Cardiol. 2013 Dec 10;170(2):132-9. doi: 10.1016/j.ijcard.2013.08.094. Epub 2013 Sep 8.'}]}, 'descriptionModule': {'briefSummary': 'Psychosocial factors play an important role in the pathophysiology of acute myocardial infarction (AMI), but it is not known if psychotherapy is beneficial after the contemporary treatment of AMI consisting of medical and interventional therapy.\n\nThe investigators have designed a randomized, controlled study to assess the effects of short-term psychotherapy (STP) on the clinical outcomes of patients who have undergone an emergency percutaneous coronary intervention (PCI) post-AMI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to San Filippo Neri Hospital for AMI and treated with primary or urgent PCI.\n* Primary PTCA is performed up to 12 hours after the beginning of chest pain in cases of STEMI, while patients with NSTEMI are enrolled if urgent PTCA is being performed within 48 hours of the onset of chest pain.\n* Only patients in whom complete revascularization is achieved are being enrolled in the study.\n\nExclusion Criteria:\n\n* Patients with psychiatric disorders or disability, cognitive impairment, or other life-threatening conditions are being excluded from the study.'}, 'identificationModule': {'nctId': 'NCT00769366', 'acronym': 'STEP-IN-AMI', 'briefTitle': 'Randomized, Controlled Study on Short-term Psychotherapy After Acute Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'San Filippo Neri General Hospital'}, 'officialTitle': 'Randomized, Controlled Study on Short-term Psychotherapy After Acute Myocardial Infarction: The Step-in-AMI Trial (Short TErm Psychotherapy IN Acute Myocardial Infarction)', 'orgStudyIdInfo': {'id': '2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Psychotherapy', 'description': 'Psychotherapy and medical therapy', 'interventionNames': ['Behavioral: Psychotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Optimal medical therapy', 'interventionNames': ['Drug: Medical therapy']}], 'interventions': [{'name': 'Psychotherapy', 'type': 'BEHAVIORAL', 'description': 'humanistic-existential psychotherapy conducted in individual and group meetings', 'armGroupLabels': ['Psychotherapy']}, {'name': 'Medical therapy', 'type': 'DRUG', 'description': 'Optimal medical therapy after Acute myocardial infarction', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00135', 'city': 'Rome', 'country': 'Italy', 'facility': 'San filippo Neri Hospital', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Filippo Neri General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Head of Research and Training section, Interventional Cardiology Unit', 'investigatorFullName': 'Christian Pristipino', 'investigatorAffiliation': 'San Filippo Neri General Hospital'}}}}