Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-01-07 @ 11:45 PM
Study NCT ID:
NCT05748860
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-01
First Post:
2023-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRecision Ecmo in CardIogenic Shock Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012770', 'term': 'Shock, Cardiogenic'}, {'id': 'D016638', 'term': 'Critical Illness'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The biomarkers of interest for the PRECISE Study include biomarkers involved in neuroprognositication (neuron specific enolase, neurofilament), mortality prediction (lactate), heart failure (Troponin, pro BNP), endothelial damage (Angiopoietin 2), inflammation and other biomarkers that may be involved in risk prediction. We will also collect samples of free genetic material (eg free mitochondria), which will not involve genome wide association, and therefore will not include information about heritable diseases in families.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 236}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-04-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-19', 'studyFirstSubmitDate': '2023-02-19', 'studyFirstSubmitQcDate': '2023-02-19', 'lastUpdatePostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disability-free survival at day 180', 'timeFrame': 'Day 180', 'description': 'Measured with the World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ECMO', 'cardiogenic shock', 'ECPR', 'critical illness', 'intensive care'], 'conditions': ['Cardiogenic Shock']}, 'descriptionModule': {'briefSummary': 'Venoarterial (VA) ECMO is a form of life support for patients with severe cardiogenic shock and cardiac arrest. Although it can be lifesaving, currently many patients still die or have long term disability, such as weakness, shortness of breath and cognitive impairments, and it remains extremely expensive. It is important that new ways of identifying which patients will gain the most benefit from ECMO are found, while also avoiding costly futile use when it there is no benefit.\n\nThe PRECISE Study is an Australian-led, nation-wide observational study that will investigate whether biomarkers can better guide decisions around to whom and how ECMO is delivered. The study will involve the collection of a small amount of blood (which would normally be discarded) at up to 4 different time points, including just prior to ECMO initiation, and also at days 1, 3, and 7 of ECMO support. These results will then be linked to a national registry which includes the important patient centred outcomes, such as disability at 6 months. This study will lead to the better support of a highly vulnerable population, and improve the efficiency of one of the most complex and costly interventions available.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is adult patients on VA-ECMO for cardiogenic shock or cardiac arrest that are or will be enrolled in the national ECMO registry (EXCEL: HREC Project 534/18).', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who will be commencing on VA ECMO (for cardiogenic shock or ECPR)\n* 18 years old or older\n* Patients who will be enrolled in the EXCEL Registry (HREC Project 534/18)\n\nExclusion Criteria:\n\n* Patients who are already on ECMO, or where\n* There are inadequate resources to complete the study'}, 'identificationModule': {'nctId': 'NCT05748860', 'acronym': 'PRECISE', 'briefTitle': 'PRecision Ecmo in CardIogenic Shock Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Australian and New Zealand Intensive Care Research Centre'}, 'officialTitle': 'PRecision Ecmo in CardIogenic Shock Evaluation', 'orgStudyIdInfo': {'id': 'ANZIC-RC/AB003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult patients commencing on VA-ECMO', 'description': 'The study population is adult patients on VA-ECMO for cardiogenic shock or cardiac arrest that are or will be enrolled in the national ECMO registry (EXCEL).'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sheraya De Silva', 'role': 'CONTACT', 'email': 'sheraya.desilva@monash.edu', 'phone': '+61 3 9903 0343'}, {'name': 'Victoria King', 'role': 'CONTACT', 'email': 'victoria.king@monash.edu', 'phone': '+61 3 9905 6646'}], 'overallOfficials': [{'name': 'Aidan JC Burrell', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Australian and New Zealand Intensive Care Research Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Australian and New Zealand Intensive Care Research Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}