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

December 5, 2016 updated by: Jeong Hoon Yang

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In hospital death
Time Frame: for 1 year
for 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jeong Hoon Yang

Investigators

  • Study Chair: Jeong Hoon Yang, Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

December 5, 2016

First Submitted That Met QC Criteria

December 5, 2016

First Posted (Estimate)

December 7, 2016

Study Record Updates

Last Update Posted (Estimate)

December 7, 2016

Last Update Submitted That Met QC Criteria

December 5, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-03-130

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe