Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-03 @ 10:03 AM
Study NCT ID:
NCT04467294
Status:
UNKNOWN
Last Update Posted:
2020-07-13
First Post:
2020-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Register on the Etiologies of Cardiogenic Shock and Their Prognosis at One Year.
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1650}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2023-10-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-08', 'studyFirstSubmitDate': '2020-07-08', 'studyFirstSubmitQcDate': '2020-07-08', 'lastUpdatePostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of Cardiac Shock', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'mortality', 'timeFrame': 'one month'}, {'measure': 'mortality', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiogenic Shock']}, 'descriptionModule': {'briefSummary': 'Cardiogenic shock (CC) is one of the major challenges of current cardiology. Despite the difficulty of establishing a strict and consensual definition, it is accepted that the CC clinically corresponds to persistent hypotension (systolic blood pressure 90 mmHg for at least 30 minutes or need for vasopressor support) associated with signs of visceral hypoperfusion (confusion, mottling, oliguria, hyperlactatemia), and hemodynamic with a lowered heart index ( 1.8 L/min/m2) despite appropriate or high filling pressures. This definition of the European Society of Cardiology (ESC) masks however the great variability of hemodynamic tables grouped under the term of CC and severity levels, also variable.However, it was suggested that the etiology of CC influenced both its hemodynamic profile and therefore its therapeutic management but also its prognosis in the medium and long term.', 'detailedDescription': 'CC diagnosis remains difficult to carry on admission and is sometimes delayed. Therefore, we would like to compare hemodynamic data from patients with CC status to those admitted for acute heart failure (ICA) to determine if a hemodynamic variable at entry would facilitate the diagnosis of CC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in Cardiac Shock and patients admitted for acute heart failure (ICA)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in Cardiac Shock :\n* 90 mmHg hypotension or requiring inotropic or vasopressor support,\n* owered cardiac output ( 1.8 L/min/m2) to trans-thoracic cardiac ultrasound with high or normal filling pressures\n* peripheral hypoperfusion. patients admitted for acute heart failure (ICA) (Acute pulmonary edema chart or left congestive heart failure without CC sign and with ultrasound FEVG at entry 40%.)\n\nExclusion Criteria:\n\n* Pregnant or nursing women\n* Age 18 years\n* Person of full age under guardianship\n* Staying in a health or social facility\n* Person not covered by a social security scheme\n* Person deprived of liberty\n* Shocks from other etiologies\n* Patient with initial cardiac arrest\n* Patient with cardiogenic shock due to right ventricular dysfunction\n* Patient with pulmonary embolism\n* Patient with tamponade\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT04467294', 'acronym': 'cardiac shock', 'briefTitle': 'Prospective Register on the Etiologies of Cardiogenic Shock and Their Prognosis at One Year.', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Prospective Register on the Etiologies of Cardiogenic Shock and Their Prognosis at One Year.', 'orgStudyIdInfo': {'id': '2019-29'}, 'secondaryIdInfos': [{'id': '2019-A01294-53', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'state': 'PACA', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'BONELLO LAURENT, PU PH', 'role': 'CONTACT', 'email': 'laurent.bonello@ap-hm.fr', 'phone': '0491968858'}], 'facility': 'Assistance Publique Hopitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'bonello laurent', 'role': 'CONTACT', 'email': 'laurent.bonello@ap-hm.fr', 'phone': '0491968858'}], 'overallOfficials': [{'name': 'Garrido-pradalie Emilie', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}