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OpenTrials
Completed

NCT Number: NCT07260084

Prognostic Impact of Frailty in Cardiogenic Shock

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?

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Key information

Conditions

Cardiogenic Shock Age Cardiovascular Diseases Frailty Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged ≥18 years who were admitted to the intensive care unit (ICU) of tertiary hospitals and were diagnosed with CS

Exclusion criteria

  • Patients diagnosed with anaphylaxis
  • Patients with a documented history of shock in the year before the index admission

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Heart failure-related rehospitalization

    Time frame: From index hospitalization until 15 years of follow-up.

    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.

  2. Cognitive impairment

    Time frame: From index hospitalization until 15 years of follow-up.

    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

  3. Mental health problems

    Time frame: From index hospitalization until 15 years of follow-up.

    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.

  4. Long-term all-cause mortality

    Time frame: From index hospitalization until 15 years of follow-up.

    Death from any cause, identified with the Statistics Korea nationwide death registry. Number of participants with the event was measured.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Prognostic Impact of Frailty in Cardiogenic Shock: Nationwide Cohort Study

Important dates

Study start
2012
Primary completion
2023
Study completion
2023
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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