Clinical trial NCT05570864: Score TO Predict SHOCK - STOP SHOCK
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiogenic Shock
Acute Coronary Syndrome
Acute Myocardial Infarction
Keywords: cardiogenic shock
acute coronary syndrome
artificial intelligence
scoring system
machine learning
acute myocardial infarction
Lead sponsor: Premedix Academy
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 50000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include a combined population of patients who suffered acute myocardial infarction recorded in national registries from several countries. An estimated 30 to 50000 new patients will be added from multiple registries to to improve the existing primary STOP SHOCK model. The incidence of cardiogenic shock in this group of patients is estimated to be 10% which would constitute the shock patient group, the rest of the patients will be included in the control group.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Development of cardiogenic shock
timeFrame: Up to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: Premedix Academy
Study officials:
affiliation: Premedix Academy, Medena 18, 81102 Bratislava, Slovakia
name: Allan Böhm, MD, PhD, MBA, FESC, FJCS
role: PRINCIPAL_INVESTIGATOR
References: