Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT05149456
Status:
UNKNOWN
Last Update Posted:
2021-12-08
First Post:
2021-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Peripheral Artery Occlusive Disease (PAOD) in Women Hospitalized for Type 1 Myocardial Infarction in Intensive Cardiology Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C564658', 'term': 'Peripheral Arterial Occlusive Disease 1'}, {'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': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-24', 'studyFirstSubmitDate': '2021-11-24', 'studyFirstSubmitQcDate': '2021-11-24', 'lastUpdatePostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study of the prevalence of peripheral artery occlusive disease (PAOD)', 'timeFrame': 'Files analysed retrospectively from January 01, 2021 to Jun 30, 2021 will be examined]'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peripheral Arterial Occlusive Disease', 'PAOD', 'Cardiovascular risk factors', 'Myocardial infarction'], 'conditions': ['PAOD - Peripheral Arterial Occlusive Disease']}, 'descriptionModule': {'briefSummary': 'The cardiovascular risk of women has been the subject of particular interest in recent years, in the world, in particular under the impetus of Cardiology companies, with more and more work focusing on the specificities of these diseases in women as well as differences in terms of management and prognosis with a literature mainly based on American data and which focuses particularly on ischemic heart disease.\n\nThe expected results are to have a prevalence of PAOD in an Alsatian cohort, most of the data we currently have from American data, with analysis of the impact of specific and non-specific risk factors in this cohort and their weight in PAOD.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult woman hospitalized in an Intensive Cardiology Unit (ICU) at the HUS for a type 1 myocardial infarction confirmed according to the criteria of the fourth universal definition of the ESC between 01/01/2021 to 30/06/2021 inclusive', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Adult woman (≥18 years old)\n* Patient hospitalized in an Intensive Cardiology Unit (ICU) at the HUS for a type 1 myocardial infarction confirmed according to the criteria of the fourth universal definition of the ESC between 01/01/2021 to 30/06/2021 inclusive\n* Patient who did not express her opposition to the reuse of her data for scientific research purposes.\n\nExclusion criteria:\n\n* Patient who expressed her opposition to participating in the study\n* Impossibility of providing the subject with enlightened information (difficulties in understanding the subject, MMS \\<20/30…)\n* Non-type 1 or unconfirmed myocardial infarction\n* Unstable or refractory shock state at the time of the echodoppler examination\n* Complication of the coronary angiography approach, in the case of femoral approach only, requiring surgical management.\n* Patient under curatorship, guardianship or judicial safeguard.'}, 'identificationModule': {'nctId': 'NCT05149456', 'acronym': 'AOMI', 'briefTitle': 'Peripheral Artery Occlusive Disease (PAOD) in Women Hospitalized for Type 1 Myocardial Infarction in Intensive Cardiology Care', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Study of the Prevalence of Peripheral Artery Occlusive Disease (PAOD) in Women Hospitalized for Type 1 Myocardial Infarction in Intensive Cardiology Care', 'orgStudyIdInfo': {'id': '8373'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dominique STEPHAN, MD, PhD', 'role': 'CONTACT', 'email': 'dominique.stephan@chru-strasbourg.fr', 'phone': '33 3 69 55 09 52'}, {'name': 'Saïd CHAYER, PhD, HDR', 'role': 'CONTACT', 'email': 'said.chayer@chru-strasbourg.fr'}, {'name': 'Dominique STEPHAN, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marjolaine TALBOT, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'François SEVERAC, Statistician', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service des Maladies VASC-HTA-Pharmacologie Clinique - Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Dominique STEPHAN, MD, PhD', 'role': 'CONTACT', 'email': 'dominique.stephan@chru-strasbourg.fr', 'phone': '33 3 69 55 09 52'}, {'name': 'Saïd CHAYER, PhD, HDR', 'role': 'CONTACT', 'email': 'said.chayer@chru-strasbourg.fr'}], 'overallOfficials': [{'name': 'Dominique STEPHAN, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service des Maladies VASC-HTA-Pharmacologie Clinique - Hôpitaux Universitaires de Strasbourg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}