NCT02985008

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 7, 2016

Status Verified

December 1, 2016

Enrollment Period

3.7 years

First QC Date

December 5, 2016

Last Update Submit

December 5, 2016

Conditions

Keywords

Shock, IVBP, ECMO, In hospital death

Outcome Measures

Primary Outcomes (1)

  • In hospital death

    for 1 year

Secondary Outcomes (7)

  • Death in 28days

    28days

  • Death in 1 year

    1 year

  • Death, myocardial infarction, stroke, re-admission due to heart failure during follow-up.

    1 year

  • Number of days of intensive care unit Number of days of intensive care unit

    1 year

  • hospitalization days

    1 year

  • +2 more secondary outcomes

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Total: 1,000 * Cardiogenic shock group with inserted IABP, ECMO : 400 * Cardiogenic shock group without inserted IABP, ECMO : 600

You may qualify if:

  • years old or older
  • 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.
  • 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.
  • Causes of cardiogenic shock include acute myocardial infarction (including in coronary intervention), cardiomyopathy, myocarditis, pulmonary embolism, refractory ventricular tachycardia, shock during coronary intervention.
  • Those voluntarily consenting to the medical records and the data necessary for the study during the entire study period.

You may not qualify if:

  • Other causes except for cardiogenic shock (low blood pressure, septic, obstructive shock)
  • Shock with cardiac arrest outside the hospital
  • People with allergic reactions to anticoagulants such as heparin.
  • Those who refused active treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, KS013, South Korea

RECRUITING

Related Publications (23)

  • 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: 20610640BACKGROUND
  • 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: 24011548BACKGROUND
  • 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: 25863737BACKGROUND
  • 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: 25828345BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Shock, CardiogenicShock

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Jeong Hoon Yang

    Samsung Medical Center

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 5, 2016

First Posted

December 7, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

December 7, 2016

Record last verified: 2016-12

Locations