Cardiogenic ShockSCOUT SPARCNCT05415332
The Current Status and Clinical OUTcomes of Cardiogenic Shock Patients And the Role of Specialist in Cardiovascular Critical Care Unit
An observational study of Cardiogenic Shock, run by Yonsei University at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiogenic Shock
- How many people
- 10,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2020to May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- (prospective)
- Patients over 19-year-old
- 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
Show all 16Show fewer
- 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
- 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.
Who cannot join
- A patient with irreparable brain damage.
- If there are no witnesses outside the hospital during cardiac arrest.
- DNR(Do Not Resuscitate) patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
Chul-Min Ahn, +82-2-2228-8326, drcello@yuhs.ac
About this study
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.
- Conditions
- Cardiogenic Shock
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
In-hospital death
Death during hospitlization
Measured: 30 days after onset of cardiogenic shock
Secondary outcomes (7)
In-hospital cardiac death
cardiac death during hospitlization
Measured: 30 days after onset of cardiogenic shock
Defective neurological indicators
Measurement using CPC(Cerebral perfomance category) score
Measured: 30 days after onset of cardiogenic shock
cardiac death within 30 days
30 Days mortality
Measured: 30 days after onset of cardiogenic shock
all cause of death within 30 days
30 Days mortality
Measured: 30 days after onset of cardiogenic shock
all cause of death during follow-up
all cause of death during follow-up
Measured: 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
Measured: 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
Measured: 30 days after onset of cardiogenic shock
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start1 Jun 2020
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chul-Min Ahn, Principal investigator, Yonsei University Health System, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415332
- Sponsor's protocol ID
- 4-2020-0383
- Acronym
- SCOUT SPARC
- Status last verified
- Jun 2022
- First submitted
- 1 Jun 2022
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Current Status and Clinical OUTcomes of Cardiogenic Shock Patients And the Role of Specialist in Cardiovascular Critical Care Unit
- ClinicalTrials.gov ID
- NCT05415332
- Acronym / sponsor ID
- SCOUT SPARC / 4-2020-0383
- Conditions
- Cardiogenic Shock
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (16 listed)
- (prospective)
- Patients over 19-year-old
- 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.
Key exclusion criteria (3 listed)
- A patient with irreparable brain damage.
- If there are no witnesses outside the hospital during cardiac arrest.
- DNR(Do Not Resuscitate) patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-hospital death
Time frame: 30 days after onset of cardiogenic shock
Death during hospitlization
7 secondary outcomes
In-hospital cardiac death
Time frame: 30 days after onset of cardiogenic shock
Defective neurological indicators
Time frame: 30 days after onset of cardiogenic shock
cardiac death within 30 days
Time frame: 30 days after onset of cardiogenic shock
all cause of death within 30 days
Time frame: 30 days after onset of cardiogenic shock
all cause of death during follow-up
Time frame: 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
Time frame: 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
Time frame: 30 days after onset of cardiogenic shock
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Cardiogenic Shock
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Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
Cardiogenic Shock, Pulmonary Edema Cardiac Cause
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Capital Offload-Shock
Hypervolemia, Cardiogenic Shock
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CRP Apheresis in Infarct-Related Cardiogenic Shock
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Cardiogenic Shock Working Group Registry
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chul-Min Ahn principal investigator
Yonsei University Health System, Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chul-Min Ahn (+82-2-2228-8326, drcello@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital death (time frame: 30 days after onset of cardiogenic shock). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.