Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2026-02-24 @ 11:00 AM
Study NCT ID:
NCT05416112
Status:
UNKNOWN
Last Update Posted:
2023-05-16
First Post:
2022-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Left Ventricle Contractility dp/dt as Prognostic Marker in Chest Unit Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '8 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-13', 'studyFirstSubmitDate': '2022-06-08', 'studyFirstSubmitQcDate': '2022-06-08', 'lastUpdatePostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACE', 'timeFrame': 'one month', 'description': 'the occurrence of a major cardiovascular event (MACE)'}, {'measure': 'MACE', 'timeFrame': 'SIX MONTHS', 'description': ': the occurrence of a major cardiovascular event (MACE)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chest pain,', 'myocardial ischemia,', 'acute myocardial dysfunction,', 'plethysmography,', 'non invasive dp/dt.'], 'conditions': ['Chest Pain']}, 'descriptionModule': {'briefSummary': 'Ischemic heart disease is a major public health problem with high mortality rate despite the progress in management and the resources mobilized. The idea is that myocardial ischemia is generally associated with left ventricular dysfunction and, consequently, a possible alteration of the dp/dt index. As dp/dt could be assessed non-invasively by plethysmographic method, it is interesting to investigate its prognostic performance in patients with indifferentiate chest pain.', 'detailedDescription': 'Ischemic heart disease remains a major public health problem. Despite all the advances in the prognostic approach to ischemic heart disease, the risk of occurrence of major cardiovascular events is not negligible. Several scores have been proposed for chest pain stratification risk, the most widely used are the TIMI and the GRACE scores.\n\nThe dP/dt max is therefore an excellent index of contractility, corresponding to the maximum level of tension developed by an isolated cardiac muscle during the isovolumic contraction phase.\n\nthe investigator theorized that a less value of dp/dt would be associated with more major cardiovascular events (MACE), because ischemia reduces myocardial contractility.\n\nThe current study describes non-invasive plethysmographic dp/dt changes, which could be used as a prognostic marker in patients presenting at the emergency department with acute chest pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients presenting to the emergency department with acute chest pain', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* age over 18 years old,\n* acute chest pain\n\nExclusion criteria:\n\n* traumatic chest pain,\n* hemodynamic instability;\n* arrhythmias;\n* holders of a pacemaker;\n* STEMI'}, 'identificationModule': {'nctId': 'NCT05416112', 'acronym': 'dp/dt', 'briefTitle': 'Non-invasive Left Ventricle Contractility dp/dt as Prognostic Marker in Chest Unit Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Monastir'}, 'officialTitle': 'Non Invasive Left Ventricle Contractility dp/dt Could be Used as a Prognostic Marker in Patients Admitted to the Emergency Department for Chest Pain', 'orgStudyIdInfo': {'id': 'dp/dt'}}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Monastir', 'status': 'RECRUITING', 'country': 'Tunisia', 'contacts': [{'name': 'Semir Nouira, professor', 'role': 'CONTACT', 'email': 'semir.nouira@rns.tn', 'phone': '73 106 085', 'phoneExt': '216'}, {'name': 'semir nouira, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emergency Departement', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}], 'centralContacts': [{'name': 'Nouira Semir, professor', 'role': 'CONTACT', 'email': 'semir.nouira@rns.tn', 'phone': '73106046', 'phoneExt': '00216'}], 'overallOfficials': [{'name': 'Nouira Semir, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monastir University Hospital, Monastir, Tunisia, 5000'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Monastir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PROFESSOR', 'investigatorFullName': 'Pr. Semir Nouira', 'investigatorAffiliation': 'University of Monastir'}}}}