Cardiogenic ShockNCT07260084
Prognostic Impact of Frailty in Cardiogenic Shock
An observational study of Cardiogenic Shock and Frailty, run by Samsung Medical Center.
Trial summary
The goal of this observational study is to show prognostic impact of frailty in cardiogenic shock according to age. The main questions it aims to answer are: Can frailty successfully predict outcomes in cardiogenic shock? Whether the impact of frailty would differ with age in cardiogenic shock? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Frailty, Age
- How many people
- 207,419 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged ≥18 years who were admitted to the intensive care unit (ICU) of tertiary hospitals and were diagnosed with CS
Who may be able to join
- Adults aged ≥18 years who were admitted to the intensive care unit (ICU) of tertiary hospitals and were diagnosed with CS
Who cannot join
- Patients diagnosed with anaphylaxis
- Patients with a documented history of shock in the year before the index admission
About this study
Official title: Prognostic Impact of Frailty in Cardiogenic Shock: Nationwide Cohort Study
The goal of this observational study is to show prognostic impact of frailty in cardiogenic shock according to age. The main questions it aims to answer are:
- Can frailty successfully predict outcomes in cardiogenic shock?
- Whether the impact of frailty would differ with age in cardiogenic shock?
- Conditions
- Cardiogenic Shock, Frailty, Age
- Keywords
- frailty, cardiogenic shock, Hospital Frailty Risk Score, Age
- Medical subject headings
- Shock, Cardiogenic, Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital all-cause mortality
Death from any cause occurring during the index hospitalization for cardiogenic shock. Number of participants with the event was measured
Measured: During index hospitalization for cardiogenic shock (up to hospital discharge)
Secondary outcomes (4)
Heart failure-related rehospitalization
Any inpatient admission with a primary or secondary diagnosis of heart failure (ICD-10 I50.x), identified from claims data and prescription records.Number of participants with the event was measured.
Measured: From index hospitalization until 15 years of follow-up.
Cognitive impairment
New-onset cognitive dysfunction after discharge, defined using ICD-10 codes (R41.x for memory disturbance, F06.7 for mild cognitive disorder) or new diagnosis of dementia (F00-F03, G30) or prescription of anti-dementia medications (donepezil, rivastigmine, galantamine, memantine). Number of participants with event was measured
Measured: From index hospitalization until 15 years of follow-up.
Mental health problems
Composite of new-onset psychiatric diagnoses after discharge including 6 domains defined using ICD-10 codes. Domains include depression (ICD-10 F32-F33), anxiety disorders (F41.x), somatization disorder (F45.x), stress-related disorders (F43.x), sleep disorders (G47.x), and substance use disorders (F10-F19). Diagnostic codes supported by prescription data (e.g., antidepressants, anxiolytics). Number of participants with the event was measured.
Measured: From index hospitalization until 15 years of follow-up.
Long-term all-cause mortality
Death from any cause, identified with the Statistics Korea nationwide death registry. Number of participants with the event was measured.
Measured: From index hospitalization until 15 years of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Jan 2012
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
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 Samsung Medical CenterThe 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
- Retrospective
- Enrolment
- 207,419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki Hong Choi, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260084
- Sponsor's protocol ID
- CS Frailty
- Status last verified
- Nov 2025
- First submitted
- 24 Sep 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Impact of Frailty in Cardiogenic Shock: Nationwide Cohort Study
- ClinicalTrials.gov ID
- NCT07260084
- Acronym / sponsor ID
- CS Frailty
- Conditions
- Cardiogenic Shock, Frailty, Age
- Keywords
- frailty, cardiogenic shock, Hospital Frailty Risk Score, Age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207,419 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 3 Dec 2025 (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.
The goal of this observational study is to show prognostic impact of frailty in cardiogenic shock according to age. The main questions it aims to answer are:
- Can frailty successfully predict outcomes in cardiogenic shock?
- Whether the impact of frailty would differ with age in cardiogenic shock?
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged ≥18 years who were admitted to the intensive care unit (ICU) of tertiary hospitals and were diagnosed with CS
Key inclusion criteria (1 listed)
- Adults aged ≥18 years who were admitted to the intensive care unit (ICU) of tertiary hospitals and were diagnosed with CS
Key exclusion criteria (2 listed)
- Patients diagnosed with anaphylaxis
- Patients with a documented history of shock in the year before the index admission
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 all-cause mortality
Time frame: During index hospitalization for cardiogenic shock (up to hospital discharge)
Death from any cause occurring during the index hospitalization for cardiogenic shock. Number of participants with the event was measured
4 secondary outcomes
Heart failure-related rehospitalization
Time frame: From index hospitalization until 15 years of follow-up.
Cognitive impairment
Time frame: From index hospitalization until 15 years of follow-up.
Mental health problems
Time frame: From index hospitalization until 15 years of follow-up.
Long-term all-cause mortality
Time frame: From index hospitalization until 15 years of follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock and Frailty, run by Samsung Medical Center.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital all-cause mortality (time frame: During index hospitalization for cardiogenic shock (up to hospital discharge)). 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 3 Dec 2025.