Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
Study NCT ID:
NCT04130269
Status:
RECRUITING
Last Update Posted:
2025-09-29
First Post:
2019-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anxiety, Stress and Pain & 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2019-10-16', 'studyFirstSubmitQcDate': '2019-10-16', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PTSD', 'timeFrame': '6 months', 'description': 'Number of patients who develop PTSD'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'People often experience the acute phase of a myocardial infarction as a stressful and traumatic event that seems lifethreatening. Such anxiety, pain and stress can lead to the development of posttraumatic stress disorder in the long run. Previous studies suggest that there might be a relevant percentage of people developing Posttraumatic Stress Disorder (PTSD) after a myocardial infarction. Posttraumatic stress disorder is a risk factor for the development of coronary heart disease. The goal of this study is to detect the percentage of people that develop symptoms of anxiety, stress, and PTSD after an acute myocardial infarction.', 'detailedDescription': 'People often experience the acute phase of a myocardial infarction as a stressful and traumatic event that seems lifethreatening. Such anxiety, pain and stress can lead to the development of posttraumatic stress disorder in the long run. Previous studies suggest that there might be a relevant percentage of people developing PTSD after a myocardial infarction. Posttraumatic stress disorder is a risk factor for the development of coronary heart disease. The goal of this study is to detect the percentage of people that develop symptoms of anxiety, stress and PTSD after an acute myocardial infarction.\n\nPatients will be examined during three times - in the acute myocardial infarction period (Day 1-3), before dismissal (Day 5-14) and after 6 months for a follow-up. During all times they will be given questionnaires asking about their levels of stress, anxiety and general well-being as well as tests checking their cognitive abilities (thus to find out if they decrease over time). Moreover, blood samples checking cortisol levels as well as metanephrine levels will be taken in order to objectify the levels of stress that are stated by the patients. Furthermore, clinical evaluations, laboratory runs (troponin), ECGs and echocardiographies will be done at all three points in time.\n\nThe goal is to detect the biopsychosocial relations and to develop better prevention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Men and women 19-90.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* willingness to participate in the study\n* men and women 19-90\n* after myocardial infarctions\n* no psychiatric disease before myocardial infarction\n* no other severe disease influencing the immune system\n\nExclusion Criteria:\n\n* non fulfilment of inclusion criteria\n* non-compliant patients (dementia, delirium)\n* steroid-therapy'}, 'identificationModule': {'nctId': 'NCT04130269', 'briefTitle': 'Anxiety, Stress and Pain & Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'The Impact of Anxiety, Stress and Pain in the Early Phase of Myocardial Infarction on the Development of Anxiety Symptoms and Posttraumatic Stress Disorder in the Long Term Outcome', 'orgStudyIdInfo': {'id': '7479'}, 'secondaryIdInfos': [{'id': '31-478 ex 18/19', 'type': 'OTHER', 'domain': 'Ethikkommission, Medical University of Graz'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with MCI', 'description': 'Patients with myocardial infarction (STEMI/NSTEMI) aged 19-90', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'Questionnaires, lab-run', 'armGroupLabels': ['Patients with MCI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Andreas Baranyi, Prof. MD', 'role': 'CONTACT', 'email': 'an.baranyi@medunigraz.at', 'phone': '+4331638586241'}], 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'centralContacts': [{'name': 'Andreas Baranyi, MD', 'role': 'CONTACT', 'email': 'an.baranyi@medunigraz.at', 'phone': '004331638513612'}, {'name': 'Hans-Bernd Rothenhäusler, MD', 'role': 'CONTACT', 'phone': '004331638513612'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}