Ignite Creation Date:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2026-02-18 @ 3:52 PM
Study NCT ID:
NCT03283995
Status:
UNKNOWN
Last Update Posted:
2018-04-11
First Post:
2017-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemodynamic Assessment in Cardiogenic Shock Regarding the Etiology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012770', 'term': 'Shock, Cardiogenic'}], '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'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-10', 'studyFirstSubmitDate': '2017-09-13', 'studyFirstSubmitQcDate': '2017-09-13', 'lastUpdatePostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Monitoring by transpulmonary thermodilution (VolumeView', 'timeFrame': '2 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiogenic Shock']}, 'descriptionModule': {'briefSummary': "The classic physiopathology of cardiogenic shock is explained by a systolic ventricular failure, responsible for a decrease in cardiac output associated with high systemic vascular resistances (SVR). This theory is currently challenged in light of the data collected in the SHOCK study, which assessed outcome of early revascularization versus initial medical stabilization, in cardiogenic shock following myocardial infarction.13 A sub-study highlighted depressed SVR in the population with ischemic cardiogenic shock, related to a systemic inflammatory response syndrome.14 Furthermore, mean FEVG was 30% in the SHOCK trial,13 with a similar distribution with post myocardial infarction heart failure patients without signs of shock.15-19 Thus, alteration of myocardial contractility can be only moderate in cardiogenic shock and isn't the only cause responsible for the hemodynamic instability.20 Recent studies suggest the important roles of the peripheral vascular system and neurohormonal system in the genesis and prolongation of cardiogenic shock.12 Vasodilation caused by nitrous oxide synthase activation27 explains the absence of compensating vasoconstriction observed during the SHOCK trial13, and leads to decreased systemic and coronary perfusion, thus increasing myocardial ischemia and initial ventricular dysfunction. 28,29 Cotter et al. conducted an interesting study of hemodynamic evaluation of various cardiac conditions where they observed a significant variability in the peripheral vascular status, with systemic vascular resistances collapsed in certain patients (similar to those observed in septic shock) and rather close to normal or very high resistances in other patients.21 However these data were obtained from a selected group of patients without differentiating the etiology of cardiogenic shock. Finally, the majority of available studies were limited to cardiogenic shock whose etiology was myocardial infarction.\n\nTherapeutic management of cardiogenic shock is based in first intention on an inotropic support by Dobutamine.11,23 However, better outcomes on contractility and microcirculatory state have been observed with the use of a vasopressor support by Norepinephrine, suggesting the importance of SVR decreasing in genesis of cardiogenic shock.14,24 Recent reviews showed very few data on inotropic treatment and association with vasopressor support,22 hence the low level of recommendations in current guidelines.11,23\n\nSo far it is crucial to accurately characterize hemodynamic status and in particular the systemic vascular resistance for patients with cardiogenic shock. Important variabilities in hemodynamic profiles observed in Cooter's trial could explain the difficulty in defining an optimal therapeutic strategy.\n\nthe investigators hypothesize that the hemodynamic profile, particularly SVR, of patients with cardiogenic shock is different depending on their etiology. Ischemic cardiogenic shock should be characterized by lower SVR, in relation to a major role of systemic inflammatory response syndrome. On the contrary, non-ischemic cardiogenic shock could be associated with normal or elevated SVR, and thus could explain the variability in distribution of SVR."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with cardiogenic shock.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persistent hypotension (systolic blood pressure \\<90 mmHg for at least 30 minutes or need for vasopressor support)\n* Signs of visceral hypoperfusion (confusion, marbling, oliguria, hyperlactataemia), 11\n* Lower heart rate (\\<1.8 L / min / m2) Adap Suitable or high filling pressures12\n\nExclusion Criteria:\n\n* Pregnant or nursing women\n* Major under guardianship\n* Person staying in a health or social facility\n* Non-beneficiaries of a social security scheme\n* Persons deprived of liberty\n* No one is able to give consent.'}, 'identificationModule': {'nctId': 'NCT03283995', 'briefTitle': 'Hemodynamic Assessment in Cardiogenic Shock Regarding the Etiology', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Hemodynamic Assessment in Cardiogenic Shock Regarding the Etiology', 'orgStudyIdInfo': {'id': '2017-15'}, 'secondaryIdInfos': [{'id': '2017-A00563-50', 'type': 'OTHER', 'domain': 'n°IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'cardiogenic shock without SCA', 'interventionNames': ['Other: Cardiac Volume Monitoring VolumeView', 'Device: echocardiography']}, {'label': 'cardiogenic shock with SCA', 'interventionNames': ['Other: Cardiac Volume Monitoring VolumeView', 'Device: echocardiography']}, {'label': 'SCA,', 'interventionNames': ['Device: echocardiography']}, {'label': 'acute left heart failure with severe alteration of LVEF', 'interventionNames': ['Device: echocardiography']}], 'interventions': [{'name': 'Cardiac Volume Monitoring VolumeView', 'type': 'OTHER', 'description': 'hemodynamic measure', 'armGroupLabels': ['cardiogenic shock with SCA', 'cardiogenic shock without SCA']}, {'name': 'echocardiography', 'type': 'DEVICE', 'description': 'hemodynamic measure', 'armGroupLabels': ['SCA,', 'acute left heart failure with severe alteration of LVEF', 'cardiogenic shock with SCA', 'cardiogenic shock without SCA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'JEAN-OLIVIER ARNAUD', 'role': 'CONTACT', 'email': 'drci@ap-hm.fr'}, {'name': 'LAURENT BONELLO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Assisatnce Publique Hopitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'laurent BONELLO', 'role': 'CONTACT', 'email': 'laurent.bonello@ap-hm.fr', 'phone': '0491968683'}, {'name': 'alexandra GIULIANI', 'role': 'CONTACT', 'email': 'drci@ap-hm.fr', 'phone': '04 91 38 27 47'}], 'overallOfficials': [{'name': 'jean-olivier ARNAUD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique Hopitaux De Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}