Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-01-13 @ 3:28 PM
Study NCT ID:
NCT02985008
Status:
UNKNOWN
Last Update Posted:
2016-12-07
First Post:
2016-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With Cardiogenic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012770', 'term': 'Shock, Cardiogenic'}, {'id': 'D012769', 'term': 'Shock'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-05', 'studyFirstSubmitDate': '2016-12-05', 'studyFirstSubmitQcDate': '2016-12-05', 'lastUpdatePostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In hospital death', 'timeFrame': 'for 1 year'}], 'secondaryOutcomes': [{'measure': 'Death in 28days', 'timeFrame': '28days'}, {'measure': 'Death in 1 year', 'timeFrame': '1 year'}, {'measure': 'Death, myocardial infarction, stroke, re-admission due to heart failure during follow-up.', 'timeFrame': '1 year'}, {'measure': 'Number of days of intensive care unit Number of days of intensive care unit', 'timeFrame': '1 year'}, {'measure': 'hospitalization days', 'timeFrame': '1 year'}, {'measure': 'Lactate 24 hour clearance', 'timeFrame': '1 year'}, {'measure': 'Successful removal of left ventricular assist device (IABP, ECMO)', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Shock, IVBP, ECMO, In hospital death'], 'conditions': ['Shock, Cardiogenic']}, 'referencesModule': {'references': [{'pmid': '20610640', 'type': 'BACKGROUND', 'citation': 'Thiele H, Allam B, Chatellier G, Schuler G, Lafont A. Shock in acute myocardial infarction: the Cape Horn for trials? Eur Heart J. 2010 Aug;31(15):1828-35. doi: 10.1093/eurheartj/ehq220. Epub 2010 Jul 7.'}, {'pmid': '24011548', 'type': 'BACKGROUND', 'citation': 'Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, de Waha A, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Lauer B, Bohm M, Ebelt H, Schneider S, Werdan K, Schuler G; Intraaortic Balloon Pump in cardiogenic shock II (IABP-SHOCK II) trial investigators. Intra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock (IABP-SHOCK II): final 12 month results of a randomised, open-label trial. Lancet. 2013 Nov 16;382(9905):1638-45. doi: 10.1016/S0140-6736(13)61783-3. Epub 2013 Sep 3.'}, {'pmid': '25863737', 'type': 'BACKGROUND', 'citation': 'Rousse N, Juthier F, Pincon C, Hysi I, Banfi C, Robin E, Fayad G, Jegou B, Prat A, Vincentelli A. ECMO as a bridge to decision: Recovery, VAD, or heart transplantation? Int J Cardiol. 2015;187:620-7. doi: 10.1016/j.ijcard.2015.03.283. Epub 2015 Mar 20.'}, {'pmid': '25828345', 'type': 'BACKGROUND', 'citation': 'Napp LC, Brehm M, Kuhn C, Schafer A, Bauersachs J. Heart against veno-arterial ECMO: Competition visualized. Int J Cardiol. 2015;187:164-5. doi: 10.1016/j.ijcard.2015.03.311. Epub 2015 Mar 21. No abstract available.'}, {'pmid': '40537419', 'type': 'DERIVED', 'citation': 'Park IH, Kim CH, Jang WJ, Oh JH, Lee WS, Yang JH, Gwon HC. Sex-Specific Differences in Management and Outcomes of Cardiogenic Shock Patients With and Without Ischemic Cardiomyopathy. Korean Circ J. 2025 Sep;55(9):795-809. doi: 10.4070/kcj.2024.0440. Epub 2025 May 28.'}, {'pmid': '40097285', 'type': 'DERIVED', 'citation': 'Kim O, Hong D, Choi KH, Lee JM, Park TK, Song YB, Hahn JY, Choi SH, Cho YH, Gwon HC, Yang JH. Sex Differences in Patients With Cardiogenic Shock Receiving Venoarterial Extracorporeal Membrane Oxygenation. Korean Circ J. 2025 Jun;55(6):541-551. doi: 10.4070/kcj.2024.0330. Epub 2025 Feb 10.'}, {'pmid': '39855461', 'type': 'DERIVED', 'citation': 'Cha JH, Choi KH, Ahn CM, Yu CW, Park IH, Jang WJ, Kim HJ, Bae JW, Kwon SU, Lee HJ, Lee WS, Jeong JO, Park SD, Park TK, Lee JM, Song YB, Hahn JY, Choi SH, Gwon HC, Yang JH. Machine learning prediction of in-hospital mortality and external validation in patients with cardiogenic shock: the RESCUE score. Rev Esp Cardiol (Engl Ed). 2025 Aug;78(8):707-716. doi: 10.1016/j.rec.2025.01.003. Epub 2025 Jan 22. English, Spanish.'}, {'pmid': '38720697', 'type': 'DERIVED', 'citation': 'Jung S, Jang WJ, Lee WS, Park IH, Oh JH, Yang JH, Gwon HC, Ahn CM, Yu CW, Kim HJ, Bae JW, Kwon SU, Lee HJ, Jeong JO, Park SD. Seasonal variation and prognosis in patients with acute myocardial infarction complicated by cardiogenic shock. Heliyon. 2024 Apr 24;10(9):e30078. doi: 10.1016/j.heliyon.2024.e30078. eCollection 2024 May 15.'}, {'pmid': '38701179', 'type': 'DERIVED', 'citation': 'Hong D, Choi KH, Ahn CM, Yu CW, Park IH, Jang WJ, Kim HJ, Bae JW, Kwon SU, Lee HJ, Lee WS, Jeong JO, Park SD, Park TK, Lee JM, Song YB, Hahn JY, Choi SH, Gwon HC, Yang JH. Clinical significance of residual ischaemia in acute myocardial infarction complicated by cardiogenic shock undergoing venoarterial-extracorporeal membrane oxygenation. Eur Heart J Acute Cardiovasc Care. 2024 Jul 24;13(7):525-534. doi: 10.1093/ehjacc/zuae058.'}, {'pmid': '38491111', 'type': 'DERIVED', 'citation': 'Jang WJ, Park IH, Oh JH, Choi KH, Song YB, Hahn JY, Choi SH, Gwon HC, Ahn CM, Yu CW, Kim HJ, Bae JW, Kwon SU, Lee HJ, Lee WS, Jeong JO, Park SD, Yang JH. Efficacy and safety of durable versus biodegradable polymer drug-eluting stents in patients with acute myocardial infarction complicated by cardiogenic shock. Sci Rep. 2024 Mar 15;14(1):6301. doi: 10.1038/s41598-024-56925-2.'}, {'pmid': '38362865', 'type': 'DERIVED', 'citation': 'Jeong JH, Kook H, Lee SH, Joo HJ, Park JH, Hong SJ, Kim MN, Park SM, Jung JS, Yang JH, Gwon HC, Ahn CM, Jang WJ, Kim HJ, Bae JW, Kwon SU, Lee WS, Jeong JO, Park SD, Lim SH, Lee J, Lee J, Yu CW. Prediction of In-Hospital Mortality for Ischemic Cardiogenic Shock Requiring Venoarterial Extracorporeal Membrane Oxygenation. J Am Heart Assoc. 2024 Feb 20;13(4):e032701. doi: 10.1161/JAHA.123.032701. Epub 2024 Feb 16.'}, {'pmid': '38072307', 'type': 'DERIVED', 'citation': 'Kim Y, Jang WJ, Park IH, Oh JH, Yang JH, Gwon HC, Ahn CM, Yu CW, Kim HJ, Bae JW, Kwon SU, Lee HJ, Lee WS, Jeong JO, Park SD. Prognostic effect of sex according to shock severity in patients with acute myocardial infarction complicated by cardiogenic shock. Hellenic J Cardiol. 2025 Mar-Apr;82:3-14. doi: 10.1016/j.hjc.2023.11.007. Epub 2023 Dec 10.'}, {'pmid': '37797547', 'type': 'DERIVED', 'citation': 'Lee HH, Jang WJ, Ahn CM, Chun WJ, Oh JH, Park YH, Lee SJ, Hong SJ, Yang JH, Kim JS, Kim HC, Kim BK, Yu CW, Kim HJ, Bae JW, Ko YG, Choi D, Gwon HC, Hong MK, Jang Y. Association of Prophylactic Distal Perfusion Cannulation With Mortality in Patients Receiving Venoarterial Extracorporeal Membrane Oxygenation. Am J Cardiol. 2023 Nov 15;207:418-425. doi: 10.1016/j.amjcard.2023.07.149. Epub 2023 Oct 3.'}, {'pmid': '37158104', 'type': 'DERIVED', 'citation': 'Choi KH, Yang JH, Park TK, Lee JM, Song YB, Hahn JY, Choi SH, Ahn CM, Yu CW, Park IH, Jang WJ, Kim HJ, Bae JW, Kwon SU, Lee HJ, Lee WS, Jeong JO, Park SD, Kang TS, Gwon HC. Culprit-Only Versus Immediate Multivessel Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction Complicating Advanced Cardiogenic Shock Requiring Venoarterial-Extracorporeal Membrane Oxygenation. J Am Heart Assoc. 2023 May 16;12(10):e029792. doi: 10.1161/JAHA.123.029792. Epub 2023 May 9.'}, {'pmid': '36996239', 'type': 'DERIVED', 'citation': 'Park IH, Jang WJ, Oh JH, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Ahn CM, Yu CW, Kim HJ, Bae JW, Kwon SU, Lee HJ, Lee WS, Jeong JO, Park SD. Non-culprit left main coronary artery disease in acute myocardial infarction complicated by cardiogenic shock. PLoS One. 2023 Mar 30;18(3):e0276711. doi: 10.1371/journal.pone.0276711. eCollection 2023.'}, {'pmid': '36746233', 'type': 'DERIVED', 'citation': 'Kwon W, Choi KH, Yang JH, Chung YJ, Park TK, Lee JM, Song YB, Hahn JY, Choi SH, Ahn CM, Yu CW, Park IH, Jang WJ, Kim HJ, Bae JW, Kwon SU, Lee HJ, Lee WS, Jeong JO, Park SD, Gwon HC. Efficacy of thrombus aspiration in cardiogenic shock complicating acute myocardial infarction and high thrombus burden. Rev Esp Cardiol (Engl Ed). 2023 Sep;76(9):719-728. doi: 10.1016/j.rec.2023.01.009. Epub 2023 Feb 4. English, Spanish.'}, {'pmid': '35658518', 'type': 'DERIVED', 'citation': 'Kwon W, Lee SH, Yang JH, Choi KH, Park TK, Lee JM, Song YB, Hahn JY, Choi SH, Ahn CM, Ko YG, Yu CW, Jang WJ, Kim HJ, Kwon SU, Jeong JO, Park SD, Cho S, Bae JW, Gwon HC. Impact of the Obesity Paradox Between Sexes on In-Hospital Mortality in Cardiogenic Shock: A Retrospective Cohort Study. J Am Heart Assoc. 2022 Jun 7;11(11):e024143. doi: 10.1161/JAHA.121.024143. Epub 2022 Jun 6.'}, {'pmid': '34663479', 'type': 'DERIVED', 'citation': 'Park IH, Yang JH, Jang WJ, Chun WJ, Oh JH, Park YH, Ko YG, Yu CW, Kim BS, Kim HJ, Lee HJ, Jeong JO, Gwon HC. Clinical significance of lactate clearance in patients with cardiogenic shock: results from the RESCUE registry. J Intensive Care. 2021 Oct 18;9(1):63. doi: 10.1186/s40560-021-00571-7.'}, {'pmid': '34246725', 'type': 'DERIVED', 'citation': 'Jang WJ, Park IH, Yang JH, Chun WJ, Oh JH, Park YH, Ko YG, Yu CW, Kim HJ, Kim BS, Lee HJ, Jeong JO, Gwon HC. Association between polyvascular disease and clinical outcomes in patients with cardiogenic shock: Results from the RESCUE registry. Int J Cardiol. 2021 Sep 15;339:70-74. doi: 10.1016/j.ijcard.2021.07.008. Epub 2021 Jul 8.'}, {'pmid': '34145983', 'type': 'DERIVED', 'citation': 'Seong SW, Jin G, Kim M, Ahn KT, Yang JH, Gwon HC, Ko YG, Yu CW, Chun WJ, Jang WJ, Kim HJ, Bae JW, Kwon SU, Lee HJ, Lee WS, Park SD, Cho SS, Ahn JH, Song PS, Jeong JO. Comparison of in-hospital outcomes of patients with vs. without ischaemic cardiomyopathy undergoing veno-arterial-extracorporeal membrane oxygenation. ESC Heart Fail. 2021 Aug;8(4):3308-3315. doi: 10.1002/ehf2.13481. Epub 2021 Jun 18.'}, {'pmid': '34129366', 'type': 'DERIVED', 'citation': 'Yang JH, Choi KH, Ko YG, Ahn CM, Yu CW, Chun WJ, Jang WJ, Kim HJ, Kim BS, Bae JW, Lee SY, Kwon SU, Lee HJ, Lee WS, Jeong JO, Park SD, Lim SH, Cho S, Park TK, Lee JM, Song YB, Hahn JY, Choi SH, Gwon HC. Clinical Characteristics and Predictors of In-Hospital Mortality in Patients With Cardiogenic Shock: Results From the RESCUE Registry. Circ Heart Fail. 2021 Jun;14(6):e008141. doi: 10.1161/CIRCHEARTFAILURE.120.008141. Epub 2021 Jun 15.'}, {'pmid': '33590998', 'type': 'DERIVED', 'citation': 'Choi KH, Yang JH, Park TK, Lee JM, Song YB, Hahn JY, Choi SH, Ko YG, Yu CW, Chun WJ, Jang WJ, Kim HJ, Bae JW, Kwon SU, Lee HJ, Lee WS, Jeong JO, Park SD, Cho S, Gwon HC. Differential Prognostic Implications of Vasoactive Inotropic Score for Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock According to Use of Mechanical Circulatory Support. Crit Care Med. 2021 May 1;49(5):770-780. doi: 10.1097/CCM.0000000000004815.'}, {'pmid': '32975059', 'type': 'DERIVED', 'citation': 'Lee HH, Hong SJ, Ahn CM, Yang JH, Gwon HC, Kim JS, Kim BK, Ko YG, Choi D, Hong MK, Jang Y. Clinical Implications of Thrombocytopenia at Cardiogenic Shock Presentation: Data from a Multicenter Registry. Yonsei Med J. 2020 Oct;61(10):851-859. doi: 10.3349/ymj.2020.61.10.851.'}]}, 'descriptionModule': {'briefSummary': 'Retrospectively and prospectively enrolled patients with cardiogenic shock in domestic manifolds and investigated the current state of treatment and clinical features of cardiogenic shock in Koreans and identified the factors that could improve the prognosis and the use of IABP and ECMO And to investigate its therapeutic effect.', 'detailedDescription': "1. The selection / exclusion criteria for persons with cardiogenic shock should be verified by medical records from January 1, 2014 before the approval date of each institution's clinical trial screening committee.\n2. If a cardiogenic shock to the selection criteria is found in the emergency room, general ward, or intensive care unit of the participating institutions, enroll in this study and fill in the information according to the e-CRF.\n3. After 1, 6 and 12 months, visit the hospital for examination and procedures. The person in charge of the examination or the delegate of the examiner may follow the person by telephone or an outpatient visit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Total: 1,000\n\n* Cardiogenic shock group with inserted IABP, ECMO : 400\n* Cardiogenic shock group without inserted IABP, ECMO : 600', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 19 years old or older\n2. ① Systolic blood pressure is less than 90mmHg for more than 30 minutes despite the fluid therapy, or Use of pressure boosting agents is necessary.\n\n ② Peripheral hypopnea (cold skin, urine less than 30 cc per hour, impaired consciousness, lactate ≥2.0 mmol / l) or a person with pulmonary edema.\n3. Causes of cardiogenic shock include acute myocardial infarction (including in coronary intervention), cardiomyopathy, myocarditis, pulmonary embolism, refractory ventricular tachycardia, shock during coronary intervention.\n4. Those voluntarily consenting to the medical records and the data necessary for the study during the entire study period.\n\nExclusion Criteria:\n\n1. Other causes except for cardiogenic shock (low blood pressure, septic, obstructive shock)\n2. Shock with cardiac arrest outside the hospital\n3. People with allergic reactions to anticoagulants such as heparin.\n4. Those who refused active treatment.'}, 'identificationModule': {'nctId': 'NCT02985008', 'acronym': 'SMART-RESCUE', 'briefTitle': 'Clinical Outcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With Cardiogenic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'SMart Angioplasty Research Team: A Multi-center, Open, REtrospective and Prospective Observational Study to Investigate Clinical oUtcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With Cardiogenic Shock : RESCUE', 'orgStudyIdInfo': {'id': '2016-03-130'}}, 'contactsLocationsModule': {'locations': [{'zip': 'KS013', 'city': 'Seoul', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jeong Hoon Yang', 'role': 'CONTACT', 'email': 'jeonghoon.yang@samsung.com'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jeong Hoon Yang', 'role': 'CONTACT', 'email': 'jeonghoon.yang@samsung.com', 'phone': '+82-10-4872-9433'}, {'name': 'Jin Hee Seo', 'role': 'CONTACT', 'email': 'rufina.seo@samsung.com', 'phone': '+82-10-6623-5673'}], 'overallOfficials': [{'name': 'Jeong Hoon Yang', 'role': 'STUDY_CHAIR', 'affiliation': 'Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jeong Hoon Yang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jeong Hoon Yang', 'investigatorAffiliation': 'Samsung Medical Center'}}}}