Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-01-01 @ 12:17 AM
Study NCT ID:
NCT04274205
Status:
COMPLETED
Last Update Posted:
2020-02-20
First Post:
2020-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Brief Supportive Psychotherapy on Major Adverse Cardiovascular Events, Neutrophil-lymphocytes Ratio and Psychological Symptoms in Acute Coronary Syndrome in Intensive Cardiac Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups Acute coronary syndrome group who got brief psychotherapy in five session in 5 days.. 30 minutes in 1 session Acute coronary syndrome group who did not get brief supportive psychotherapy as control Double opened RCT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-18', 'studyFirstSubmitDate': '2020-02-14', 'studyFirstSubmitQcDate': '2020-02-14', 'lastUpdatePostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiovascular events', 'timeFrame': '5 days', 'description': 'Fatal arrhytmia, recurrent myocardial infarction, cardiogenic shock, death'}], 'secondaryOutcomes': [{'measure': 'Neutrophil-lymphocytes ratio', 'timeFrame': '5 days', 'description': 'Pre-post measure'}, {'measure': 'Psychological symptoms (Hospital anxiety depression scale)', 'timeFrame': '5 days', 'description': 'Pre-post measure'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brief supportive psychotherapy, acute coronary syndrome, major adverse cardiovascular events, neutrophil-lymphocytes ratio, psychological symptoms'], 'conditions': ['Acute Coronary Syndrome', 'Brief Supportive Psychotherapy', 'Intensive Cardiac Care Unit']}, 'descriptionModule': {'briefSummary': 'There was no MACE in both groups, but there was stroke-major adverse vascular event lower in brief supportive psychotherapy group. There was neutrophil-lymphocytes ratio change better in brief supportive psychotherapy group and significantly in acute coronary syndrome patients without chronic heart failure or coronary arterial disease, also there was psychological symptom (depression) change better in brief supportive psychotherapy and significantly in acute coronary syndrome patients with chronic heart failure or coronary arterial disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute coronary syndrome\n* 》 18 years old\n* have got pharmacological treatment in cardiology standard with or without anxiolytic drug and had got or had not yet got PCI\n* be able to communicate and ready to have interview, fill the questioners and psychotherapy\n\nExclusion Criteria:\n\n* stroke\n* cardiogenic shock at admission time\n* psychosis\n* reject to involve in study'}, 'identificationModule': {'nctId': 'NCT04274205', 'acronym': 'Supportive', 'briefTitle': 'Influence of Brief Supportive Psychotherapy on Major Adverse Cardiovascular Events, Neutrophil-lymphocytes Ratio and Psychological Symptoms in Acute Coronary Syndrome in Intensive Cardiac Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Influence of Brief Supportive Psychotherapy on Major Adverse Cardiovascular Events, Neutrophil-lymphocytes Ratio and Psychological Symptoms in Acute Coronary Syndrome Patients in Intensive Cardiac Care Unit', 'orgStudyIdInfo': {'id': 'KET-177/UN2.F1/ETIK/PPM.00.02/'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Influence on brief supportive psychotherapy', 'description': 'Intervention group', 'interventionNames': ['Other: Intervention group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Influence of brief supportive psychotherapy', 'description': 'Control group', 'interventionNames': ['Other: Intervention group']}], 'interventions': [{'name': 'Intervention group', 'type': 'OTHER', 'otherNames': ['Control group'], 'description': 'Brief supportive psychotherapy', 'armGroupLabels': ['Influence of brief supportive psychotherapy', 'Influence on brief supportive psychotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Medical Faculty', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Psychosomatic Division', 'investigatorFullName': 'Hamzah Shatri', 'investigatorAffiliation': 'Indonesia University'}}}}