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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02985008
Acronym
SMART-RESCUE
Enrollment
1000
Registered
2016-12-07
Start date
2016-04-30
Completion date
2019-12-31
Last updated
2016-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shock, Cardiogenic

Keywords

Shock, IVBP, ECMO, In hospital death

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 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.

Interventions

None listed

Sponsors

Jeong Hoon Yang
Lead SponsorOTHER

Study design

Observational model
COHORT

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
In hospital deathfor 1 year

Secondary

MeasureTime frame
Death in 1 year1 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 unit1 year
Death in 28days28days
Lactate 24 hour clearance1 year
Successful removal of left ventricular assist device (IABP, ECMO)1 year
hospitalization days1 year

Countries

South Korea

Contacts

Primary ContactJeong Hoon Yang
jeonghoon.yang@samsung.com+82-10-4872-9433
Backup ContactJin Hee Seo
rufina.seo@samsung.com+82-10-6623-5673

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026