Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2025-12-24 @ 2:17 PM
Study NCT ID:
NCT04513795
Status:
UNKNOWN
Last Update Posted:
2020-08-14
First Post:
2020-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EARLY-MYO-SEPSIS Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-12', 'studyFirstSubmitDate': '2020-08-10', 'studyFirstSubmitQcDate': '2020-08-12', 'lastUpdatePostDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'composite of death, stroke, heart failure', 'timeFrame': '2 years', 'description': 'composite of death, stroke, heart failure'}], 'secondaryOutcomes': [{'measure': 'day of hospitalization', 'timeFrame': 'through study completion, 2 months', 'description': 'day from admission to discharge'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'The diagnosis and pathophysiology of sepsis-induced cardiac dysfunction remain unknown. This registry is to evaluate characteristics of sepsis patients by multi-modalities imaging, including echocardiography, cardiovascular magnetic resonance imaging in 300 patients in 5 sites. Subjects will be followed up to 2 years.', 'detailedDescription': "Approximately 20-30 million patients worldwide suffer from sepsis every year, which is increasing at the rate of 8% to 13% per year. It is possible that sepsis progress to multiple organ dysfunction in the early stage, with a fatality of 30% to 60%. Myocardium is one of the most vulnerable tissue under the abnormal 'inflammation storm'.Cardiac dysfunction is one of the important predictors for mortality of sepsis.Patients with myocardial depression have an apparently higher mortality rate (70%) as compared with septic patients without cardiac impairment (20%).\n\nAlthough several trials had explored the diagnosis and treatment of sepsis-induced cardiac dysfunction, the effective characteristic depict and effective therapy remain incompletely understand.\n\nThis is a prospective, multi-center, non-randomized, observational registry study of sepsis patients that undergo multi-modality imaging."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were diagnosed as sepsis or suspected as sepsis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patiants meets the criteria of Sepsis 3.0 as below:\n* Sepsis is a lifethreatening organ dysfunction caused by a dysregulated host response to infection\n* 1 patients in ICU：\n* 1.1 have at least one organ dysfunction\n* 1.2 SOFA score ≥2\n* 2 patients not in ICU\n* 2.1 have at least one organ dysfunction\n* 2.2 SOFA score or qSOFA score ≥2\n\nExclusion Criteria:\n\n* 1\\. Patient who is unable to comply with the follow-up schedule.\n* 2\\. Patient who has any medical conditions that in the opinion of the investigators will not be appropriate to participate in the study.\n* 3\\. Patient has a life expectancy of less than 6 months due to any condition'}, 'identificationModule': {'nctId': 'NCT04513795', 'briefTitle': 'EARLY-MYO-SEPSIS Registry', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'EARLY-MYO-SEPSIS (EARLY Assessment of MYOcardial Injury in Sepsis Patient) Registry', 'orgStudyIdInfo': {'id': 'EARLY-MYO-SEPSIS'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jun Pu, PhD, FACC, FESC', 'role': 'CONTACT', 'email': 'pujun310@hotmail.com', 'phone': '13817577592'}, {'name': 'Lingcong Kong', 'role': 'CONTACT', 'email': 'avrilblanche373@126.com', 'phone': '13857766365'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}