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Trial record 1 of 1 for:    NCT02985008
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Clinical Outcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With Cardiogenic Shock (SMART-RESCUE)

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ClinicalTrials.gov Identifier: NCT02985008
Recruitment Status : Unknown
Verified December 2016 by Jeong Hoon Yang, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : December 7, 2016
Last Update Posted : December 7, 2016
Sponsor:
Information provided by (Responsible Party):
Jeong Hoon Yang, Samsung Medical Center

Study Description
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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.

Condition or disease
Shock, Cardiogenic

Detailed Description:
  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.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Target Follow-Up Duration: 1 Year
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 Patients With Cardiogenic Shock : RESCUE
Study Start Date : April 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. In hospital death [ Time Frame: for 1 year ]

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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Total: 1,000

  • Cardiogenic shock group with inserted IABP, ECMO : 400
  • Cardiogenic shock group without inserted IABP, ECMO : 600
Criteria

Inclusion Criteria:

  1. 19 years old or older

  2. 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.

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

Exclusion Criteria:

  1. Other causes except for cardiogenic shock (low blood pressure, septic, obstructive shock)
  2. Shock with cardiac arrest outside the hospital
  3. People with allergic reactions to anticoagulants such as heparin.
  4. Those who refused active treatment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02985008


Contacts
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Contact: Jeong Hoon Yang +82-10-4872-9433 jeonghoon.yang@samsung.com
Contact: Jin Hee Seo +82-10-6623-5673 rufina.seo@samsung.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul City, Seoul, Korea, Republic of, KS013
Contact: Jeong Hoon Yang       jeonghoon.yang@samsung.com   
Sponsors and Collaborators
Jeong Hoon Yang
Investigators
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Study Chair: Jeong Hoon Yang Samsung Medical Center
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jeong Hoon Yang, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02985008    
Other Study ID Numbers: 2016-03-130
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jeong Hoon Yang, Samsung Medical Center:
Shock, IVBP, ECMO, In hospital death
Additional relevant MeSH terms:
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Shock, Cardiogenic
Shock
Pathologic Processes
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Vascular Diseases
Infarction
Ischemia
Necrosis