Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-04-03 @ 9:58 AM
Study NCT ID:
NCT05321667
Status:
UNKNOWN
Last Update Posted:
2022-04-11
First Post:
2022-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patients Without Standard Modifiable Cardiovascular Risk Factors (SMuRF-less) and Their Prognosis After a ST-segment-Elevation Myocardial Infarction (STEMI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-04', 'studyFirstSubmitDate': '2022-03-26', 'studyFirstSubmitQcDate': '2022-04-04', 'lastUpdatePostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACE (Major Adverse Cardiovascular Event)', 'timeFrame': '3 years', 'description': 'Composite outcome including cardiovascular death or incidence of acute coronary syndrome, ischemic stroke or heart failure.'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '3 years'}, {'measure': 'Number of patients presenting cardiovascular death during the follow-up', 'timeFrame': '3 years', 'description': 'Number of patients presenting death due to fatal myocardial infarction, fatal ischemic stroke, sudden death, severe heart failure and cardiogenic shock during the follow-up.'}, {'measure': 'Number of patients presenting heart failure during the follow-up', 'timeFrame': '3 years', 'description': 'Number of patients hospitalized for acute heart failure during the follow-up, as well as patients presenting persistent symptoms of chronic heart failure after their STEMI (dyspnea NYHA \\> 1) and/or long-terme need for diuretics.'}, {'measure': 'Number of patients presenting ischemic stroke during the follow-up', 'timeFrame': '3 years', 'description': 'Number of patients presenting fatal or non fatal ischemic stroke during the follow-up'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SMuRFs', 'SMuRF-less', 'Standard Modifiable Risk Factors', 'Prognosis', 'Family History'], 'conditions': ['STEMI']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to asses the prognosis of STEMI patients without standard modifiable risk factors of cardiovascular disease (diabetes mellitus, hyperlipidemia, hypertension and cigarette smoking) compare to patients presenting at least one of these risk factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Systematic review of STEMI patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSTEMI patients who had a percutaneous coronary intervention (PCI) in our PCI center.\n\nExclusion Criteria:\n\nPain duration exceeding 24h. Perioperative STEMI, including STEMI related to cardiac surgery.'}, 'identificationModule': {'nctId': 'NCT05321667', 'briefTitle': 'Patients Without Standard Modifiable Cardiovascular Risk Factors (SMuRF-less) and Their Prognosis After a ST-segment-Elevation Myocardial Infarction (STEMI)', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Patients Without Standard Modifiable Cardiovascular Risk Factors (SMuRF-less) and Their Prognosis After a ST-segment-Elevation Myocardial Infarction (STEMI)', 'orgStudyIdInfo': {'id': '2021PI154'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SMuRF-less', 'description': 'Patients presenting no standard modifiable risk factor of cardiovascular disease (diabetes mellitus, hyperlipidemia, hypertension, and cigarette smoking).'}, {'label': 'SMuRFs', 'description': 'Patients presenting at least one standard modifiable risk factor of cardiovascular disease (diabetes mellitus, hyperlipidemia, hypertension, and cigarette smoking).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'state': 'Meurthe-et-Moselle', 'country': 'France', 'contacts': [{'name': 'Lucas SALVATI', 'role': 'CONTACT', 'email': 'lu.k.salvati@gmail.com', 'phone': '+33620607540'}], 'facility': 'Institut du Coeur et des Vaisseaux Louis Mathieu', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'Lucas SALVATI', 'role': 'CONTACT', 'email': 'lu.k.salvati@gmail.com', 'phone': '+33620607540'}, {'name': 'Batric POPOVIC', 'role': 'CONTACT', 'email': 'b.popovic@chru-nancy.fr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Batric POPOVIC', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}