The Current Status and Clinical OUTcomes of Cardiogenic Shock Patients And the Role of Specialist in Cardiovascular Critical Care Unit (SCOUT SPARC)

In the case of cardiogenic shock, the early mortality rate is the highest compared to other types of shock, but it is characterized by a good prognosis and quality of life after recovery, so monitoring the treatment progress is very important to identify the patient's prognosis. However, there are few studies specifically reported on hemodynamic monitoring and prognosis of cardiogenic shock. In addition, as mechanical circulatory support devices are in the spotlight, studies on their effects and safety are starting, but studies on cardiogenic shock are often limited to patients with myocardial infarction.

This study is a prospective and retrospective cohort observational study, we aim to identify factors that can improve prognosis, including various drug treatments, diagnostic techniques, and mechanical circulatory support device by investigating the treatment status and clinical outcomes of patients with cardiogenic shock hospitalized in cardiovascular critical care unit. In addition, the purpose of this study is to investigate the association between the prognosis of patients with cardiogenic shock and the presence of a specialist resident during regular work hours to clarify the role and necessity of a resident specialist in the cardiovascular intensive care unit.

Furthermore, by predicting and treating the clinical course of patients with cardiogenic shock at an early stage, the aim is to reduce the mortality rate and improve the patients' ability to perform daily activities.

Study Overview

• Status: Recruiting
• Conditions: Cardiogenic Shock

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Chul-Min Ahn; Phone Number: +82-2-2228-8326; Email: drcello@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Yonsei University Health system, Severance Hospital
    • Contact: Chul-Min Ahn; Phone Number: +82-2-2228-8326; Email: drcello@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

(prospective) Patients over 19-year-old who have been hospitalized in cardiovascular critical care unit for cardiogenic shock and other causes of decreased blood pressure after the IRB approval date.

(retrospective) Patients over 19-year-old who treated in the cardiovascular critical care unit from January 1, 2018 to the IRB approval date for decreased blood pressure or needed intensive monitoring of vital signs.

Description

Inclusion Criteria:

(prospective)

1. Patients over 19-year-old

2. Patients who are hospitalized in the cardiovascular critical care unit for cardiogenic shock or reduced blood pressure due to other causes.

   2-1) In the event that the systolic blood pressure is less than 90mmHg for at least 30 minutes despite fluid treatment, or the use of vasopressor drug is required to maintain systolic blood pressure more than 90mmHg.

   2-2) patients have at least one of the symptoms of peripheral tissue hypoperfusion (cold skin, urineoutput < 30cc/ hour, decreased consciousness, lactate > 2.0mmol/l) or pulmonary edema.

   2-3) Patients supported by Mechanical Circulatory support device

3. Where the cause of a cardiogenic shock conforms to one or more of the following matters:

   3-1) In the case of an intervention or surgery has been performed due to coronary artery disease, peripheral artery disease, venous thromboembolism, pulmonary artery disease, aortic disease, etc.

   3-2) In the case of an intervention or surgery has been performed due to valve disease.

   3-3) In the case of the insertion of an instrument in the heart is performed due to atrial defect, left atrium, arteriosclerosis, etc.

   3-4) In the case of ablation or surgery, defibrillator implantation, and pacemaker implantation.

   3-5) In the case of pericardiocentesis or window formation has been performed due to cardiac tamponade.

   3-6) When monitoring is required for hypothermia therapy after spontaneous circulation recovery.

   3-7) When monitoring is required after other heart-related procedures or surgery 3-8) When monitoring is required after heart transplant

4. Where a patient or legal representative voluntarily agrees to access medical records and data necessary for this study during the entire study period

(retrospective) Patients over 19-year-old who treated in the cardiovascular critical care unit from January 1, 2018 to the IRB approval date for decreased blood pressure or needed intensive monitoring of vital signs.

Exclusion Criteria:

1. A patient with irreparable brain damage.
2. If there are no witnesses outside the hospital during cardiac arrest.
3. DNR(Do Not Resuscitate) patients

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cardiogenic shock patients; We will collect patient's demographic information, medical history, vital signs, cardiac arrest, the maximum dose of the drug at shock treatment and whether mechanical circulatory support devices are inserted, indicators of deterioration and improvement of shock. For follow-up observations, only prospective subjects are examined for results and administrative information conducted by visiting an outpatient at the time of one, six, one, two, three, four, and five or more years after the shock.
Patients hospitalized in cardiovascular intensive care unit; we will collect patient's demographic information, medical history related to cardiovascular disease, and vital signs on the admission date to the cardiovascular critical care unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital death	Death during hospitlization	30 days after onset of cardiogenic shock

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital cardiac death	cardiac death during hospitlization	30 days after onset of cardiogenic shock
Defective neurological indicators	Measurement using CPC(Cerebral perfomance category) score	30 days after onset of cardiogenic shock
cardiac death within 30 days	30 Days mortality	30 days after onset of cardiogenic shock
all cause of death within 30 days	30 Days mortality	30 days after onset of cardiogenic shock
all cause of death during follow-up	all cause of death during follow-up	Outpatient visits at the time of one month, six months, one year, two years, three years, four years and five years from the date of the cardiogenic shock.
Major Adverse Cardiovascular Events during follow-up	Major Adverse Cardiovascular events(MACE) is defined CVD events, admission for heart failure, ischemic cardiovascular events, bleeding events, cardiac death, heart transplactation, other thromboembolism	Outpatient visits at the time of one month, six months, one year, two years, three years, four years and five years from the date of the cardiogenic shock.
successful weaning of mechanical circulatory support device	if successful weaning of mechanical circulatory support device or not	30 days after onset of cardiogenic shock

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Chul-Min Ahn, Yonsei University Health System Severance Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2020
• Primary Completion (ANTICIPATED): May 1, 2030
• Study Completion (ANTICIPATED): May 1, 2030

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (ACTUAL): June 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Shock; Shock, Cardiogenic
• Other Study ID Numbers: 4-2020-0383

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No