NCT06692855

Brief Summary

Cardiogenic shock (CS) is characterized by tissue hypoperfusion resulting from cardiac dysfunction, without hypovolemia, where the ventricular pump is unable to generate adequate blood flow to meet the metabolic needs of the organs. To date, the management of CS is a challenge for cardiologists and intensive care physicians, particularly with regard to the stratification of the severity of these patients to accurately determine the prognostic outcome. Thus, although specific prognostic scores for CS already exist, they are often inefficient and difficult to calculate quickly at the patient's bedside. For example, the CardShock risk score is a score composed of seven variables (including biological and echocardiographic parameters) allowing in the best case to obtain an area under the curve (AUC) for the prediction of mortality around 0.7. More recently, the SCAI Shock classification was developed to progressively stratify patients into five groups of increasing severity, ranging from A to E for the most serious. Although its prognostic interest is better than the CardShock, this recently updated classification is also based on biological or echocardiographic parameters that are sometimes difficult to collect in an emergency. Thus, there is currently no simple and optimal prognostic score to predict the prognosis of patients and even less of a score that takes into account the overall clinical fragility of patients appropriately. In this context, the Rockwood clinical fragility score, also called the "Clinical Frailty Scale" (CFS), has emerged in recent years as an iconographic score accompanied by an explanatory text initially developed to assess fragility in the elderly. It is a pure declarative score, very easy to perform in clinical practice, even in acute situations or in delirious or even sedated patients. It also has the advantage of being free since it only groups together the physiological and functional data characterizing the previous state of a subject before the diagnostic and therapeutic stage. The CFS makes it possible to estimate the degree of fragility of a patient ranging from "very fit" or robust, active, energetic to "terminal phase". It is based on information that is easily retrieved from the patient or the patient's relatives with the advantage of having a very good correlation with the fragility scores that are more complex to evaluate. Finally, the CSF has already proven its worth in acute cardiology, such as in myocardial infarction where this score was independently and strongly associated with all-cause mortality at 6 months and where it was highlighted that fragile patients had a poorer outcome, a higher risk of mortality, risk of CS and risk of bleeding. Optimal management of CS patients requires both a thorough, rapid, reliable and easy-to-obtain assessment in an emergency in order to initiate appropriate interventions as quickly as possible. In this perspective, the CFS emerges as a promising parameter in the initial assessment of these patients, particularly to identify patients with a higher risk of complications. This score alone or in addition to the scores already used in practice in the CS represents an innovative perspective and could allow a more detailed assessment of patients and thus help clinicians to better target the necessary interventions and to individualize the management. Indeed, optimizing the identification of patients with acute critical cardiology is one of the avenues suggested as an area for improvement by experts in this field at the border of cardiology and resuscitation. The simplicity of this tool, combined with its ability to assess the overall vulnerability of the patient, opens the way to increased personalization of care in CS patients.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

October 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 14, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

November 18, 2024

Status Verified

November 1, 2024

Enrollment Period

1.1 years

First QC Date

November 14, 2024

Last Update Submit

November 14, 2024

Conditions

Keywords

Cardiogenic shockCardShock risk scoreArea under the curve (AUC)SCAI Shock classificationClinical Frailty Scale (CFS)

Outcome Measures

Primary Outcomes (1)

  • Death at 28 days after cardiogenic shock

    28 days after cardiogenic shock

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patient (≥18 years) with cardiogenic shock according to ESC 2021 definition

You may qualify if:

  • Adult patient (≥18 years)
  • Patient with cardiogenic shock according to ESC 2021 definition
  • Patient hospitalized from January 1, 2014 to September 1, 2024 in an Intensive Care Unit
  • Patients who do not object to the re-use of their data for the purposes of this research.

You may not qualify if:

  • Patient having expressed his opposition to the re-use of his data for scientific research purposes.
  • Subject under court protection.
  • Subject under guardianship or curatorship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Médecine Intensive - Réanimation - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2024

First Posted

November 18, 2024

Study Start

October 1, 2024

Primary Completion

November 1, 2025

Study Completion

November 30, 2025

Last Updated

November 18, 2024

Record last verified: 2024-11

Locations