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

Shock, Cardiogenic Clinical Trial

— SMART-RESCUE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02985008
• Other study ID #: 2016-03-130
• Status: Recruiting
• Phase: N/A
• First received: December 5, 2016
• Last updated: December 5, 2016
• Start date: April 2016
• Est. completion date: December 2019

Study information

• Verified date: December 2016
• Source: Samsung Medical Center
• Contact: Jeong Hoon Yang
• Phone: +82-10-4872-9433
• Email: jeonghoon.yang[@]samsung.com
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. 19 years old or older

2. ? Systolic blood pressure is less than 90mmHg for more than 30 minutes despite the fluid therapy, or Use of pressure boosting agents is necessary.

? 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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Shock
• Shock, Cardiogenic

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul City	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Jeong Hoon Yang

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

Napp LC, Brehm M, Kühn C, Schäfer 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. — View Citation

Rousse N, Juthier F, Pinçon 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. — View Citation

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. Review. — View Citation

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, Böhm 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In hospital death		for 1 year	No
Secondary	Death in 28days		28days	No
Secondary	Death in 1 year		1 year	No
Secondary	Death, myocardial infarction, stroke, re-admission due to heart failure during follow-up.		1 year	No
Secondary	Number of days of intensive care unit Number of days of intensive care unit		1 year	No
Secondary	hospitalization days		1 year	No
Secondary	Lactate 24 hour clearance		1 year	No
Secondary	Successful removal of left ventricular assist device (IABP, ECMO)		1 year	No