Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-26 @ 1:36 AM
Study NCT ID:
NCT03539133
Status:
UNKNOWN
Last Update Posted:
2022-05-05
First Post:
2018-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Systemic Organ Communication in STEMI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D000740', 'term': 'Anemia'}], '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': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'prospectively defined blood sampling protocol'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-04', 'studyFirstSubmitDate': '2018-05-03', 'studyFirstSubmitQcDate': '2018-05-25', 'lastUpdatePostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACCE (cardiovascular death, non-fatal stroke or myocardial infarction)', 'timeFrame': '12 months', 'description': 'MACCE (cardiovascular death, non-fatal stroke or myocardial infarction)'}, {'measure': 'Rehospitalization due to heart failure', 'timeFrame': '12 months', 'description': 'Rehospitalization due to heart failure'}], 'secondaryOutcomes': [{'measure': 'Patency rate', 'timeFrame': '6 months'}, {'measure': 'left ventricular enddiastolic volume index (LVEDVi)', 'timeFrame': '6 months', 'description': 'left ventricular enddiastolic volume as indexed on body surface area by either cardiovascular magnet resonance or echocardiography'}, {'measure': 'Ejection fraction (%)', 'timeFrame': '6 months', 'description': 'Ejection fraction (%) indexed on body surface area measured by either cardiovascular magnet resonance or echocardiography'}, {'measure': 'stroke volume', 'timeFrame': '6 months', 'description': 'stroke volume indexed on body surface area measured by either cardiovascular magnet resonance or echocardiography'}, {'measure': 'Restenosis rate', 'timeFrame': '6 months', 'description': 'Percent of patients with restenosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['STEMI', 'infarction', 'coronary artery disease', 'comorbidities', 'diabetes', 'anemia'], 'conditions': ['ST-segment Elevation Myocardial Infarction (STEMI)']}, 'referencesModule': {'references': [{'pmid': '39226457', 'type': 'DERIVED', 'citation': 'Benkhoff M, Alde K, Ehreiser V, Dahlmanns J, Metzen D, Haurand JM, Duse DA, Jung C, Kelm M, Petzold T, Polzin A. Thromboinflammation is associated with clinical outcome after ST-elevation myocardial infarction. Blood Adv. 2024 Nov 12;8(21):5581-5589. doi: 10.1182/bloodadvances.2024014273.'}, {'pmid': '37138228', 'type': 'DERIVED', 'citation': 'Bonner F, Jung C, Polzin A, Erkens R, Dannenberg L, Ipek R, Kaldirim M, Cramer M, Wischmann P, Zaharia OP, Meyer C, Flogel U, Levkau B, Godecke A, Fischer J, Klocker N, Kruger M, Roden M, Kelm M. SYSTEMI - systemic organ communication in STEMI: design and rationale of a cohort study of patients with ST-segment elevation myocardial infarction. BMC Cardiovasc Disord. 2023 May 3;23(1):232. doi: 10.1186/s12872-023-03210-1.'}]}, 'descriptionModule': {'briefSummary': 'Despite progress in pre-hospital care, ambulance logistics, pharmacotherapy and PPCI techniques, ST-segment elevation myocardial infarction (STEMI) continues to confer a substantial burden of morbidity and mortality.\n\nWithin the STEMI population, there is a spectrum of higher and lower risk patients. The aim of this cohort study is to collect prospectively and systematically clinical research data from STEMI patients. This cohort study is an open-end observational study to identify master switches in myocardial ischemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from STEMI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from STEMI\n\nExclusion Criteria:\n\n* \\< 18 years'}, 'identificationModule': {'nctId': 'NCT03539133', 'acronym': 'SYSTEMI', 'briefTitle': 'Systemic Organ Communication in STEMI', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'Systemic Organ Communication in STEMI', 'orgStudyIdInfo': {'id': '17-018'}}, 'armsInterventionsModule': {'interventions': [{'name': 'collection of clinical data', 'type': 'OTHER', 'description': 'prospectively and systematically collection of clinical research data from STEMI patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christian Jung, MD, PhD', 'role': 'CONTACT'}, {'name': 'Florian Bönner, MD', 'role': 'CONTACT', 'email': 'florian.boenner@med.uni-duesseldorf.de'}, {'name': 'Christian Jung, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Malte Kelm, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Division of Cardiology, Pulmonary Disease and Vascular Medicine', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'centralContacts': [{'name': 'Christian Jung, MD, PhD', 'role': 'CONTACT', 'email': 'christian.jung@med.uni-duesseldorf.de', 'phone': '+492118118800'}, {'name': 'Florian Bönner, MD,', 'role': 'CONTACT', 'email': 'florian.boenner@med.uni-duesseldorf.de', 'phone': '+492118118800'}], 'overallOfficials': [{'name': 'Christian Jung, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Cardiology, Pulmonary Disease and Vascular Medicine'}, {'name': 'Malte Kelm, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Division of Cardiology, Pulmonary Disease and Vascular Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}