Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-02-20 @ 6:42 PM
Study NCT ID:
NCT06690567
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-15
First Post:
2024-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcomes of Contemporary IMPELLA Devices in Cardiogenic Shock and High-risk Percutaneous Coronary Intervention
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': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2024-11-04', 'studyFirstSubmitQcDate': '2024-11-13', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'long-term overall mortality', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': '30-day overall and cardiovascular mortality', 'timeFrame': '30 day'}, {'measure': 'Rate of acute kidney injury (AKIN classification) and need for renal replacement therapy (RRT)', 'timeFrame': '12 months'}, {'measure': 'Rate of bleedings according to the BARC classification', 'timeFrame': '12 months'}, {'measure': 'Rate of vascular complications, limb-ischemia, hemolysis (INTERMACS definition)', 'timeFrame': '12 months'}, {'measure': 'Rate of neurological events (stroke and TIA)', 'timeFrame': '12 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IMPELLA', 'CARDIOGENIC SHOCK', 'COMPLEX PCI'], 'conditions': ['Cardiogenic Shock', 'PCI Patients', 'Mechanical Circulatory Support']}, 'referencesModule': {'references': [{'pmid': '35192839', 'type': 'BACKGROUND', 'citation': "O'Neill WW, Anderson M, Burkhoff D, Grines CL, Kapur NK, Lansky AJ, Mannino S, McCabe JM, Alaswad K, Daggubati R, Wohns D, Meraj PM, Pinto DS, Popma JJ, Moses JW, Schreiber TL, Magnus Ohman E. Improved outcomes in patients with severely depressed LVEF undergoing percutaneous coronary intervention with contemporary practices. Am Heart J. 2022 Jun;248:139-149. doi: 10.1016/j.ahj.2022.02.006. Epub 2022 Feb 19."}, {'pmid': '22935569', 'type': 'BACKGROUND', 'citation': "O'Neill WW, Kleiman NS, Moses J, Henriques JP, Dixon S, Massaro J, Palacios I, Maini B, Mulukutla S, Dzavik V, Popma J, Douglas PS, Ohman M. A prospective, randomized clinical trial of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump in patients undergoing high-risk percutaneous coronary intervention: the PROTECT II study. Circulation. 2012 Oct 2;126(14):1717-27. doi: 10.1161/CIRCULATIONAHA.112.098194. Epub 2012 Aug 30."}, {'pmid': '31422925', 'type': 'BACKGROUND', 'citation': 'Chieffo A, Ancona MB, Burzotta F, Pazzanese V, Briguori C, Trani C, Piva T, De Marco F, Di Biasi M, Pagnotta P, Casu G, Giustino G, Montorfano M, Pappalardo F, Tarantini G; Collaborators. Observational multicentre registry of patients treated with IMPella mechanical circulatory support device in ITaly: the IMP-IT registry. EuroIntervention. 2020 Feb 7;15(15):e1343-e1350. doi: 10.4244/EIJ-D-19-00428.'}, {'pmid': '32040163', 'type': 'BACKGROUND', 'citation': 'Dhruva SS, Ross JS, Mortazavi BJ, Hurley NC, Krumholz HM, Curtis JP, Berkowitz A, Masoudi FA, Messenger JC, Parzynski CS, Ngufor C, Girotra S, Amin AP, Shah ND, Desai NR. Association of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump With In-Hospital Mortality and Major Bleeding Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock. JAMA. 2020 Feb 25;323(8):734-745. doi: 10.1001/jama.2020.0254.'}, {'pmid': '30586755', 'type': 'BACKGROUND', 'citation': 'Schrage B, Ibrahim K, Loehn T, Werner N, Sinning JM, Pappalardo F, Pieri M, Skurk C, Lauten A, Landmesser U, Westenfeld R, Horn P, Pauschinger M, Eckner D, Twerenbold R, Nordbeck P, Salinger T, Abel P, Empen K, Busch MC, Felix SB, Sieweke JT, Moller JE, Pareek N, Hill J, MacCarthy P, Bergmann MW, Henriques JPS, Mobius-Winkler S, Schulze PC, Ouarrak T, Zeymer U, Schneider S, Blankenberg S, Thiele H, Schafer A, Westermann D. Impella Support for Acute Myocardial Infarction Complicated by Cardiogenic Shock. Circulation. 2019 Mar 5;139(10):1249-1258. doi: 10.1161/CIRCULATIONAHA.118.036614.'}, {'pmid': '35862152', 'type': 'BACKGROUND', 'citation': 'Geller BJ, Sinha SS, Kapur NK, Bakitas M, Balsam LB, Chikwe J, Klein DG, Kochar A, Masri SC, Sims DB, Wong GC, Katz JN, van Diepen S; American Heart Association Acute Cardiac Care and General Cardiology Committee of the Council on Clinical Cardiology; Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Peripheral Vascular Disease; and Council on Cardiovascular Surgery and Anesthesia. Escalating and De-escalating Temporary Mechanical Circulatory Support in Cardiogenic Shock: A Scientific Statement From the American Heart Association. Circulation. 2022 Aug 9;146(6):e50-e68. doi: 10.1161/CIR.0000000000001076. Epub 2022 Jul 7.'}, {'pmid': '37622654', 'type': 'BACKGROUND', 'citation': 'Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.'}, {'pmid': '31100109', 'type': 'BACKGROUND', 'citation': 'Potapov EV, Antonides C, Crespo-Leiro MG, Combes A, Farber G, Hannan MM, Kukucka M, de Jonge N, Loforte A, Lund LH, Mohacsi P, Morshuis M, Netuka I, Ozbaran M, Pappalardo F, Scandroglio AM, Schweiger M, Tsui S, Zimpfer D, Gustafsson F. 2019 EACTS Expert Consensus on long-term mechanical circulatory support. Eur J Cardiothorac Surg. 2019 Aug 1;56(2):230-270. doi: 10.1093/ejcts/ezz098.'}, {'pmid': '23212552', 'type': 'BACKGROUND', 'citation': 'Lauten A, Engstrom AE, Jung C, Empen K, Erne P, Cook S, Windecker S, Bergmann MW, Klingenberg R, Luscher TF, Haude M, Rulands D, Butter C, Ullman B, Hellgren L, Modena MG, Pedrazzini G, Henriques JP, Figulla HR, Ferrari M. Percutaneous left-ventricular support with the Impella-2.5-assist device in acute cardiogenic shock: results of the Impella-EUROSHOCK-registry. Circ Heart Fail. 2013 Jan;6(1):23-30. doi: 10.1161/CIRCHEARTFAILURE.112.967224. Epub 2012 Dec 4.'}]}, 'descriptionModule': {'briefSummary': 'The IMMERGE registry is an observational, international multicentric study, including patients underwent IMPELLA implantation in the participating centers both for cardiogenic shock and high-risk PCI. Only IMPELLA CP, 5.0 and 5.5 devices will be included. Consecutive patients with CS and CHIPs implanted with Impella® CP, 5.0 and 5.5 with at least 6 months of follow-up completed will be enrolled in the registry. Baseline clinical and echocardiographic variables, peri-procedural haemodynamic parameters, laboratoristic findings and complications, together with follow-up outcomes data will be recorded in a dedicated database.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Paitents with cardiogenic shock or CHIP-PCI who underwent Impella device implantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females ≥ 18 years-old with CS or CHIPs\n* Impella® device implanted (CP, 5, 5.5)\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* No Impella implanted'}, 'identificationModule': {'nctId': 'NCT06690567', 'acronym': 'IMMERGE', 'briefTitle': 'Clinical Outcomes of Contemporary IMPELLA Devices in Cardiogenic Shock and High-risk Percutaneous Coronary Intervention', 'organization': {'class': 'OTHER', 'fullName': 'A.O.U. Città della Salute e della Scienza'}, 'officialTitle': 'Clinical Outcomes of Contemporary IMPELLA Devices in Cardiogenic Shock and High-risk Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'IMMMERGE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with cardiogenic shock or patients undergoing complex PCI, with Impella implantation', 'description': 'Impella implantation as only intervention needed', 'interventionNames': ['Device: Impella implantation']}], 'interventions': [{'name': 'Impella implantation', 'type': 'DEVICE', 'description': 'To implante Impella', 'armGroupLabels': ['Patient with cardiogenic shock or patients undergoing complex PCI, with Impella implantation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Torino', 'state': 'Italy', 'country': 'Italy', 'facility': 'AOU Città della Salute e della Scienza di Torino', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'A.O.U. Città della Salute e della Scienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': "Fabrizio D'Ascenzo", 'investigatorAffiliation': 'University of Turin, Italy'}}}}