Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-03 @ 5:04 PM
Study NCT ID:
NCT05312320
Status:
UNKNOWN
Last Update Posted:
2022-11-16
First Post:
2022-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Sexual Function After Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-11', 'studyFirstSubmitDate': '2022-03-11', 'studyFirstSubmitQcDate': '2022-03-28', 'lastUpdatePostDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Does specific sexual counselling improve sexual functioning in post-MI?', 'timeFrame': '12 months', 'description': 'The investigators will measure sexual function by Brief Sexual Function Inventory (BSFI) for male participants and Female Sexual Function Index (FSFI) for female participants at 6 and 12 months after their MI.'}, {'measure': 'Changes in sexual activity and functioning after MI', 'timeFrame': '12 months', 'description': 'The investigators will measure sexual activity and function at baseline, and 6 and 12 months after MI.\n\nThe investigators will measure sexual function by Brief Sexual Function Inventory (BSFI) for male participants and Female Sexual Function Index (FSFI) for female participants.'}, {'measure': 'Establish predictors of improved sexual functioning in post-MI patients', 'timeFrame': '12 months', 'description': 'In order to identify MI patients at risk of sexual dysfunction, the participants will answer questionnaires on quality of life (RAND-12), depression and anxiety (HADS), demographic data, comorbidity, medications and other factors that may have impact on sexual function.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sexual Function Disturbances', 'Myocardial Infarction']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://betami.org', 'label': 'control group'}]}, 'descriptionModule': {'briefSummary': 'The study is completely digital. Men and women who recently had an MI will be invited through a written brochure that will be present in all Norwegian departments of cardiology. Post-MI patients can check the investigators web site (www.sefh.no) to determine whether they are eligible for the study. After consent and answering the baseline questionnaire, each participant will be randomized to either the intervention or control group.\n\nControl group: Standard surveillance after MI (no specific focus on sexual activity and functioning) Intervention group: Online sexual counselling including a short information film.\n\nIn order to assess the generalizability of the results, we will compare the age, sex and MI treatment of the respondents with data on Norwegian MI-patients in general.', 'detailedDescription': 'The investigators will include 600 women and 600 men within 4 weeks after an acute MI. The investigators will invite the same number of women and men from the general population, invited through mass and social media.\n\nAll participants will be provided the same questionnaire at 4 weeks. Then outcome data will be obtained by a follow-up quest after 6 and 12 months.\n\nThe intervention is a film with the following main message:\n\n* Sexual activity after MI does not increase risk of recurrence or death\n* Sexual activity is associated with improved outcome after MI\n* Resuming sexual activity as normal is recommended and completely safe'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women ≥18 years old\n* Acute MI during the last 6 weeks\n* Informed consent for participation\n\nExclusion Criteria:\n\n* Lack of ability to cooperate\n* Known alcohol- or drug-abuse, or use of narcotics\n* Pregnancy or breast-feeding\n* Serious comorbidity with a life expectancy \\<12 months\n* Unstable or refractory angina\n* Uncontrolled hypertension\n* Congestive heart failure (NYHA class III/IV)\n* High-risk arrhythmias\n* Hypertrophic obstructive and other cardiomyopathies\n* Severe valvular disease'}, 'identificationModule': {'nctId': 'NCT05312320', 'acronym': 'Sex/MI', 'briefTitle': 'Improving Sexual Function After Myocardial Infarction', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sorlandet Hospital HF'}, 'officialTitle': 'Improving Sexual Function After Myocardial Infarction - a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': '20/09003-10-521'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Information film', 'description': 'Randomized to receive a short information film online.', 'interventionNames': ['Other: Information film']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': 'No film, only questionnaire.'}], 'interventions': [{'name': 'Information film', 'type': 'OTHER', 'description': '* Sexual activity after MI does not increase risk of recurrence or death\n* Sexual activity is associated with improved outcome after MI\n* Resuming sexual activity as normal is recommended and completely safe', 'armGroupLabels': ['Information film']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Arendal', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Vibeke Salvesen, MD', 'role': 'CONTACT'}], 'facility': 'Www.Sefh.No', 'geoPoint': {'lat': 58.46151, 'lon': 8.77253}}], 'centralContacts': [{'name': 'Vibeke Salvesen, MD', 'role': 'CONTACT', 'email': 'vibeke.salvesen@sshf.no', 'phone': '+47 47304802'}, {'name': 'Nora Johansen, Ph.D', 'role': 'CONTACT', 'email': 'nora.johansen@sshf.no', 'phone': '+47 40496612'}], 'overallOfficials': [{'name': 'Frode Gallefoss', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sorlandets hospital HF'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sorlandet Hospital HF', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Oslo University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}