Clinical Trial: Clinical Outcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With Cardiogenic Shock

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: 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 Pati

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.

Detailed Summary:

  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.
  2. 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.
  3. 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.

Sponsor: Jeong Hoon Yang

Current Primary Outcome: In hospital death [ Time Frame: for 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Death in 28days [ Time Frame: 28days ]
  • Death in 1 year [ Time Frame: 1 year ]
  • Death, myocardial infarction, stroke, re-admission due to heart failure during follow-up. [ Time Frame: 1 year ]
  • Number of days of intensive care unit Number of days of intensive care unit [ Time Frame: 1 year ]
  • hospitalization days [ Time Frame: 1 year ]
  • Lactate 24 hour clearance [ Time Frame: 1 year ]
  • Successful removal of left ventricular assist device (IABP, ECMO) [ Time Frame: 1 year ]


Original Secondary Outcome: Same as current

Information By: Samsung Medical Center

Dates:
Date Received: December 5, 2016
Date Started: April 2016
Date Completion: December 2019
Last Updated: December 5, 2016
Last Verified: December 2016