Cardiogenic ShockFrailShockNCT06692855
Prognostic Value of the Rockwood Clinical Frailty Score in Cardiogenic Shock
An observational study of Cardiogenic Shock, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2024to 30 Nov 2025
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patient (≥18 years) with cardiogenic shock according to ESC 2021 definition
Who may be able to join
- 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.
- Criteria Exclusion:
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Médecine Intensive - Réanimation - CHU de Strasbourg - France
Strasbourg, 67091
Hamid MERDJI, MD, 33 3 69 55 11 23, hamid.merdji@chru-strasbourg.fr
Hamid MERDJI, MD
About this study
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.
Read more
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.
- Conditions
- Cardiogenic Shock
- Keywords
- Cardiogenic shock, CardShock risk score, Area under the curve (AUC), SCAI Shock classification, Clinical Frailty Scale (CFS)
- Medical subject headings
- Shock, Cardiogenic
What is being measured
The primary outcome is the main question the study is designed to answer.
Death at 28 days after cardiogenic shock
Measured: 28 days after cardiogenic shock
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start1 Oct 2024
- Primary completionNov 2025 (estimated)
- Study completion30 Nov 2025 (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 University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692855
- Sponsor's protocol ID
- 9454
- Acronym
- FrailShock
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 18 Nov 2024
- 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 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of the Rockwood Clinical Frailty Score in Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT06692855
- Acronym / sponsor ID
- FrailShock / 9454
- Conditions
- Cardiogenic Shock
- Keywords
- Cardiogenic shock, CardShock risk score, Area under the curve (AUC), SCAI Shock classification, Clinical Frailty Scale (CFS)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 18 Nov 2024 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patient (≥18 years) with cardiogenic shock according to ESC 2021 definition
Key inclusion criteria (8 listed)
- 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.
- Patient having expressed his opposition to the re-use of his data for scientific research purposes.
Key exclusion criteria (0 listed)
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
Death at 28 days after cardiogenic shock
Time frame: 28 days after 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 18 Nov 2024.
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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.
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 University Hospital, Strasbourg, France at 1 site in France.
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 8 inclusion and 0 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 18 Nov 2024. 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 France. 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 Hamid MERDJI, MD (33 3 69 55 11 23, hamid.merdji@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death at 28 days after cardiogenic shock (time frame: 28 days after 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 18 Nov 2024.