Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT04178434
Status:
RECRUITING
Last Update Posted:
2025-03-07
First Post:
2019-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-based Treatment of Stress and Anxiety in Myocardial Infarction With Non-obstructive Coronary Arteries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D054549', 'term': 'Takotsubo Cardiomyopathy'}], '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'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-24', 'size': 267047, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-24T09:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2019-11-11', 'studyFirstSubmitQcDate': '2019-11-25', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-rated stress as determined by Perceived Stress Scale 14 (PSS-14)', 'timeFrame': '12-14 weeks after the acute event', 'description': 'Normalisation of PSS-14 (\\<25 on a scale 0-56 with high numbers indicating increased stress)'}, {'measure': 'Self-rated anxiety as determined by Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '12-14 weeks after the acute event', 'description': 'Normalisation of HADS-A (\\<8 on a scale 0-21 with high numbers indicating increased anxiety)'}], 'secondaryOutcomes': [{'measure': 'Self-rated stress as determined by Perceived Stress Scale 14 (PSS-14)', 'timeFrame': '10, 20 and 50 weeks after randomisation', 'description': 'PSS-14 (\\<25 on a scale 0-56 with high numbers indicating increased stress)'}, {'measure': 'Self-rated anxiety as determined by Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '10, 20 and 50 weeks after randomisation', 'description': 'HADS-A (\\<8 on a scale 0-21 with high numbers indicating increased anxiety)'}, {'measure': 'Self-rated quality-of-life determined by Research ANd Development-36 (RAND-36)', 'timeFrame': '10, 20 and 50 weeks after randomisation', 'description': 'RAND-36: 0-100 with high numbers indicating better quality-of-life'}, {'measure': 'Self-rated cardiac anxiety determined by Cardiac Anxiety Questionnaire (CAQ)', 'timeFrame': '10, 20 and 50 weeks after randomisation', 'description': 'CAQ: 0-72 with high numbers indicating increased cardiac anxiety'}, {'measure': 'Self-rated post-traumatic symptoms determined by Impact of Event Scale-6 (IES-6)', 'timeFrame': '10, 20 and 50 weeks after randomisation', 'description': 'IES-6: 0-30 with high numbers indicating increased post-traumatic symptoms'}, {'measure': 'Sick leave', 'timeFrame': '10, 20 and 50 weeks after randomisation', 'description': 'Self-reported total number of days'}, {'measure': 'Health-care visits', 'timeFrame': '10, 20 and 50 weeks after randomisation', 'description': 'Self-reported total number of visits'}, {'measure': 'Cortisol in hair', 'timeFrame': '10 weeks after randomisation', 'description': 'Hair cortisol will be determined by RIA-technique in pg/mg'}, {'measure': 'Physiological recovery after stress determined by Heart Rate Variability (HRV)', 'timeFrame': '10 weeks after randomisation', 'description': 'HRV will be measured by time and frequency domains and by non-linear methods'}, {'measure': 'Physiological recovery after stress determined by salivary cortisol', 'timeFrame': '10 weeks after randomisation', 'description': 'Salivary cortisol will be determined by RIA-technique in pg/mg'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myocardial infarction', 'Non-obstructive coronary arteries', 'Takotsubo syndrome'], 'conditions': ['Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '35910688', 'type': 'DERIVED', 'citation': 'Rondung E, Humphries SM, Olsson EMG, Sundelin R, Norlund F, Held C, Spaak J, Tornvall P, Lynga P. Reducing stress and anxiety in patients with myocardial infarction with non-obstructive coronary arteries or Takotsubo syndrome: A non-randomized feasibility study. Internet Interv. 2022 Jul 21;29:100562. doi: 10.1016/j.invent.2022.100562. eCollection 2022 Sep.'}, {'pmid': '35883115', 'type': 'DERIVED', 'citation': 'Olsson EMG, Norlund F, Rondung E, Humphries SM, Held C, Lynga P, Spaak J, Sundin O, Sundelin R, Leissner P, Kovamees L, Tornvall P. The e-mental health treatment in Stockholm myocardial infarction with non-obstructive coronaries or Takotsubo syndrome study (E-SMINC): a study protocol for a randomised controlled trial. Trials. 2022 Jul 26;23(1):597. doi: 10.1186/s13063-022-06530-3.'}]}, 'descriptionModule': {'briefSummary': 'Patient with myocardial infarction with non-obstructive coronary arteries and takotsubo syndrome often have high levels of stress and anxiety. At present there are no treatment alternatives in this group of patients. Previously, cognitive behavioral therapy (CBT), primarily aiming at relieving stress, has been shown to decrease morbidity in patient with myocardial infarction with obstructive coronary arteries. The present open randomized study aims to decrease stress and anxiety in patients with myocardial infarction with non-obstructive coronary arteries and takotsubo syndrome by an internet-based CBT focusing on stress and anxiety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a suspected diagnosis of MINOCA or takotsubo syndrome with coronary angiography without diameter stenosis ≥50%\n* age 35-80 years\n* admission-ECG with sinus rhythm\n* PSS-14 ≥ 25 and/or HADS-A ≥ 8 during admission\n* reading and writing proficiency in Swedish\n* computer/Internet access and literacy\n\nExclusion Criteria:\n\n* strong clinical suspicion of myocarditis\n* spontaneous coronary artery dissection\n* acute pulmonary embolism\n* acute myocardial infarction type 2\n* cardiomyopathy other than takotsubo syndrome\n* a previous myocardial infarction due to CAD\n* expected poor compliance to behavioural therapy\n* not likely to survive \\> one year due to for example cancer'}, 'identificationModule': {'nctId': 'NCT04178434', 'acronym': 'e-SMINC', 'briefTitle': 'Internet-based Treatment of Stress and Anxiety in Myocardial Infarction With Non-obstructive Coronary Arteries', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'E-health Treatment of Stress and Anxiety in Stockholm Myocardial Infarction With Non-obstructive Coronaries Study', 'orgStudyIdInfo': {'id': '20191111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Internet-based CBT intervention', 'description': 'A nine step internet-based intervention with focus on stress and anxiety', 'interventionNames': ['Behavioral: Internet-based CBT intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as usual', 'description': 'Regular follow-up with two doctor and one nurse appointment'}], 'interventions': [{'name': 'Internet-based CBT intervention', 'type': 'BEHAVIORAL', 'description': 'A nine step intervention including internet-based feedback by psychologists', 'armGroupLabels': ['Internet-based CBT intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11883', 'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Per Tornvall', 'role': 'CONTACT', 'email': 'per.tornvall@ki.se'}], 'facility': 'Södersjukhuset', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'centralContacts': [{'name': 'Per Tornvall, MD', 'role': 'CONTACT', 'email': 'per.tornvall@ki.se', 'phone': '+46861611000'}, {'name': 'Patrik Lyngå, RN', 'role': 'CONTACT', 'email': 'patrik.lynga@ki.se'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Per Tornvall', 'class': 'OTHER'}, 'collaborators': [{'name': 'Uppsala University', 'class': 'OTHER'}, {'name': 'Mid Sweden University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Per Tornvall', 'investigatorAffiliation': 'Karolinska Institutet'}}}}