Score TO Predict SHOCK - STOP SHOCK

Acute Coronary Syndrome Clinical Trial

Official title:

Artificial Intelligence Based Predictive Scoring System to Identify the Risk of Developing Cardiogenic Shock (CS) in Patients Suffering From Acute Coronary Syndrome (ACS)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05570864
• Other study ID #: 0012022
• Status: Enrolling by invitation
• Start date: October 2022
• Est. completion date: December 2023

Study information

• Verified date: October 2022
• Source: Premedix Academy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The goal of this international multicenter study is to develop a scoring system to identify the risk of developing cardiogenic shock (CS) in patients suffering from acute coronary syndrome (ACS) utilising artificial intelligence.

Study hypothesis:

A complex machine learning (ML) model utilising standard patient's admission data predicts the development of cardiogenic shock in patients suffering from acute myocardial infarction better than standard prediction models.

Study objectives:

The primary objective of this study is to further improve predictive parameters of #STOPSHOCK model for prediction of development of cardiogenic shock in patients suffering from acute myocardial infarction.

The secondary objective of this study is to develop a new predictive model for the development of cardiogenic shock in patients suffering from acute myocardial infarction based on larger combined cohort of patients utilising advanced ML algorithms, continuous model performance monitoring and continual learning.

Description:

Background:

Cardiogenic shock is a serious life-threatening condition affecting almost 10% of patients suffering from acute coronary syndrome (ACS). When untreated, it can rapidly progress to collapse of circulation and sudden death. Despite recent improvements in diagnostic and treatment options, mortality remains incredibly high, reaching nearly 50%.

Currently available mechanical circulatory support devices can replace the function of the heart and/or lungs, thereby essentially eliminating the primary cause. However, cardiogenic shock is not only an isolated decrease in cardiac function but a rapidly progressing multiorgan dysfunction accompanied by severe cellular and metabolic abnormalities. The window for successful treatment is relatively narrow, and when missed, even the elimination of the underlying primary cause is not enough to reverse this vicious circle.

The ability to identify high-risk patients prior to the development of shock would allow to take pre-emptive measures, such as the implantation of mechanical circulatory support, and thus prevent the development of shock leading to improved survival.

Rationale:

The AI-based scoring system could aid in identifying high-risk patients prior to the development of cardiogenic shock. This would allow taking pre-emptive measures, implanting mechanical circulatory support, and thus prevent the development of shock, leading to improved survival.

For this purpose, a predictive scoring system STOP SHOCK (Score TO Predict SHOCK) was developed. This scoring system showed better prediction compared to standard models. STOP SHOCK was validated on an external cohort of patients with area under the curve (AUC) of 0.844 surpassing other externally validated cardiogenic shock (CS) models (e.g. ORBI score). Furthermore, this model is based on variables that are readily available at the first contact with patients and thus STOPSHOCK can be utilized in emergency room (ER) or ambulance even before catheterization.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50000
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria for study population:

1. Patients with at least one ICD9 diagnosis code:

• 41000 - 41092: various versions of Acute myocardial infarction

• 41189: Other acute and subacute forms of ischemic heart disease, other

• 4139: Other and unspecified angina pectoris

2. Patients with at least one ICD9 diagnosis code:

• 78551: Cardiogenic shock

• 78550: Shock, unspecified

3. Patients with at least one ICD9 procedures codes:

• 0066: Percutaneous transluminal coronary angioplasty [PTCA]

• 3604: Intracoronary artery thrombolytic infusion

• 3606: Insertion of non-drug-eluting coronary artery stent(s)

• 3607: Insertion of drug-eluting coronary artery stent(s)

• 3609: Other removal of coronary artery obstruction

• 8855: Coronary arteriography using a single catheter

• 8856: Coronary arteriography using two catheters

• 8857: Other and unspecified coronary arteriography

• 3722: Left heart cardiac catheterization

• 3723: Combined right and left heart cardiac catheterization

Inclusion criteria for control group:

1. Patients with at least one ICD9 diagnosis code:

• 41000 - 41092: various versions of Acute myocardial infarction

• 41189: Other acute and subacute forms of ischemic heart disease, other

• 4139: Other and unspecified angina pectoris

2. Patients with at least one of the ICD9 procedures codes:

• 0066: Percutaneous transluminal coronary angioplasty [PTCA]

• 3604: Intracoronary artery thrombolytic infusion

• 3606: Insertion of non-drug-eluting coronary artery stent(s)

• 3607: Insertion of drug-eluting coronary artery stent(s)

• 3609: Other removal of coronary artery obstruction

• 8855: Coronary arteriography using a single catheter

• 8856: Coronary arteriography using two catheters

• 8857: Other and unspecified coronary arteriography

• 3722: Left heart cardiac catheterization

• 3723: Combined right and left heart cardiac catheterization

Exclusion criteria for control group:

1. Patients without ICD9 diagnosis codes:

• 78551: Cardiogenic shock

• 78550: Shock, unspecified

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Myocardial Infarction
• Cardiogenic Shock
• Infarction
• Myocardial Infarction
• Shock
• Shock, Cardiogenic
• Syndrome

Locations

Country	Name	City	State
Slovakia	Premedix Academy	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
Premedix Academy

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of cardiogenic shock	Development of cardiogenic shock (CS) in patients suffering from acute coronary syndrome (ACS)	Up to 72 hours

External Links

•   STOP SHOCK website