Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-04-04 @ 1:02 AM
Study NCT ID:
NCT03831204
Status:
COMPLETED
Last Update Posted:
2020-07-20
First Post:
2018-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systolic Time Intervals a Prognostic Tool of Heart Failure in Emergency Departement (STI/AHF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 642}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-17', 'studyFirstSubmitDate': '2018-07-06', 'studyFirstSubmitQcDate': '2019-02-02', 'lastUpdatePostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'compare the STIs prognostic performance against clinical scores', 'timeFrame': '30 days', 'description': 'the area under ROC curve of the Systolic Time Intervals compared to the one of the EFFECT and GWTG HF scores'}], 'secondaryOutcomes': [{'measure': 'compare the STI prognostic performance between HFpEF and HFrEF patients', 'timeFrame': '30 days', 'description': 'compare the STI prognostic performance between HFpEF and HFrEF patients using the area under curve estimation of the ROC curve of the three systolic time intervals (PEP;EMAT measured in milliseconds,and PEP/EMAT) of the two groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['impedance', 'dyspnea', 'AHF', 'BNP', 'EFFECT', 'GWTG-HF'], 'conditions': ['Dyspnea', 'Heart Failure']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.urgencemonastir.com', 'label': 'official department website'}]}, 'descriptionModule': {'briefSummary': 'The performance of STIs and clinical scores alone and their combination to predict short term prognosis of acute decompensated heart failure.', 'detailedDescription': 'Acute heart failure is a leading cause of hospitalization and death.Prediction of these adverse events is still challenging.\n\nSTI is an old technique based on the recording of two parameters: electrocardiogram and phonocardiogram, and from them measuring the different systolic intervals:\n\npre-ejection period (PEP),electro-mechanic activation time (EMAT), Left ventricular ejection time (LVET) and systolic time ratio (RTS) were measured.\n\nThe aim of these study is to demonstrate whether systolic time intervals (STIs) can improve clinical scores EFFECT (Enhanced Feedback for Effective Cardiac Treatment) and GWTG-HF (Get With the Guidelines-Heart Failure) for predicting 30 day mortality and readmission in patients with acute decompensated heart failure (ADHF) in the ED.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patients aged more than 18 years admitted to the ED with the diagnosis of acute decompensated heart failure', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non traumatic dyspnea\n* age more than 18 years old.\n\nExclusion Criteria:\n\n* ECG diagnostic for acute myocardial infarction\n* ischemic chest pain within the prior 24 hours\n* history of a heart transplant\n* pericardial effusion\n* chest wall deformity suspected of causing dyspnea\n* coma\n* shock,Mechanical Ventilation, vasopressor drugs\n* arrhythmia serious and sustained,\n* pace maker\n* severe mitral valve disease,\n* severe pulmonary arterial hypertension\n* renal failure with creatinine \\>350micromol/l'}, 'identificationModule': {'nctId': 'NCT03831204', 'briefTitle': 'Systolic Time Intervals a Prognostic Tool of Heart Failure in Emergency Departement (STI/AHF)', 'organization': {'class': 'OTHER', 'fullName': 'University of Monastir'}, 'officialTitle': 'Systolic Time Intervals a Pronostic Tool of Heart Failure in Emergency Departement', 'orgStudyIdInfo': {'id': 'STI in AHF prognostic'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AHF/HFpEF', 'description': 'AHF with preserved ejection fraction Acoustic cardiography was performed for all participants using the BIOPAC Prognostic scores were calculated for every patient', 'interventionNames': ['Device: biopac', 'Diagnostic Test: prognostic scores']}, {'label': 'AHF/HFrEF', 'description': 'AHF with reduced ejection fraction Acoustic cardiography was performed for all participants using the BIOPAC Prognostic scores were calculated for every patient', 'interventionNames': ['Device: biopac', 'Diagnostic Test: prognostic scores']}], 'interventions': [{'name': 'biopac', 'type': 'DEVICE', 'description': 'Acoustic cardiography was performed for all participants using the BIOPAC system with "Student Lab" software version 3.7.2. An electrocardiogram was obtained by two electrodes placed at the right upper limb and the lower left limb. Simultaneously heart sounds were recorded with a specific sensor placed at the mitral focus.', 'armGroupLabels': ['AHF/HFpEF', 'AHF/HFrEF']}, {'name': 'prognostic scores', 'type': 'DIAGNOSTIC_TEST', 'description': 'Effect and GWTGHF were calculated for every patient', 'armGroupLabels': ['AHF/HFpEF', 'AHF/HFrEF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Monastir', 'country': 'Tunisia', 'facility': 'Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}], 'overallOfficials': [{'name': 'Nouira Semir, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University hospital of Monastir'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Monastir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pr. Semir Nouira', 'investigatorAffiliation': 'University of Monastir'}}}}