NCT04143893

Brief Summary

The investigation of patient characteristics and prognostic factors of the patients presented with cardiogenic shock (CS) will guide us to identify the better management strategy for these critically ill patients. Mechanical circulatory support (MCS) may improve the prognosis of some of severe subset of CS patients. The better understanding of the indications of initiation and weaning of MCS will improve the prognosis of critically ill CS patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

4.6 years

First QC Date

October 23, 2019

Last Update Submit

October 30, 2019

Conditions

Cardiogenic Shock

Keywords

Cardiogenic shockMechanical Circulatory Support

Outcome Measures

Primary Outcomes (1)

  • In-hospital all-cause mortality

    Death in-hospital

    Up to 12 weeks

Secondary Outcomes (7)

  • In-hospital cardiac mortality

    Up to 12 weeks

  • In-hospital neurologic outcome

    Up to 12 weeks

  • Death in 30days

    30 Days after admission

  • Cardiac death in 30 days

    30 Days after admission

  • MACE

    through study completion, an average of 1 year

  • +2 more secondary outcomes

Study Arms (2)

Cardiogenic shock with MCS

Patients with cardiogenic shock who underwent MCS

Device: Mechanical circulatory supportDrug: Optimal medical treatment

Cardiogenic shock without MCS

Patients with cardiogenic shock who did not undergo MCS

Drug: Optimal medical treatment

Interventions

Mechanical circulatory supportDEVICE

Patients with cardiogenic shock who underwent MCS

Cardiogenic shock with MCS
Optimal medical treatmentDRUG

Patients with cardiogenic shock who received optimal medical treatment including vasopressor

Cardiogenic shock with MCSCardiogenic shock without MCS

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

About 1000 patient with cardiogenic shock

You may qualify if:

  • years old or older
  • Cardiogenic shock is defined as the presence of the following:
  • Systolic blood pressure is less than 90mmHg for more than 30 minutes despite the fluid therapy, or the use of pressure boosting agents to maintain the systolic blood pressure more than 90 mmHg.
  • Peripheral hypoperfusion (cold skin, urine less than 30 cc per hour, impaired consciousness, lactate ≥2.0 mmol/l) or a person with pulmonary edema.
  • Causes of cardiogenic shock include ischemic (acute myocardial infarction or ischemic cardiomyopathy, shock during cardiac intervention), myocardial (end-stage heart failure, myocarditis), post-cardiotomy shock, cardiac tamponade, or pulmonary thromboembolism.
  • Those voluntarily consenting to the medical records and the data necessary for the study during the entire study period.

You may not qualify if:

  • Other causes except for cardiogenic shock: septic shock, cardiac arrest by serious ventricular arrhythmia not related to the myocardial ischemia or heart failure
  • Shock with unwitnessed cardiac arrest outside the hospital
  • Severe non-cardiac morbidity with expected survival less than 6 months (malignancy, respiratory failure)
  • Those who refused active treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Study Officials

  • Hyeon-Cheol Gwon, MD,PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeong Hoon Yang, MD, PhD

CONTACT

82-2-3410-3419jhysmc@gmail.com

Ki Hong Choi, MD

CONTACT

82-10-8875-1648cardiokh@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 23, 2019

First Posted

October 29, 2019

Study Start

May 30, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

November 1, 2019

Record last verified: 2019-10

Locations

KR(1)