Score TO Predict SHOCK - STOP SHOCK

NCT05570864 | Unknown

• 1 other identifier: 0012022
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiogenic Shock; Acute Coronary Syndrome; Acute Myocardial Infarction

Keywords

cardiogenic shock; acute coronary syndrome; artificial intelligence; scoring system; machine learning; acute myocardial infarction

Outcome Measures

Primary Outcomes (1)

• Development of cardiogenic shock

  Development of cardiogenic shock (CS) in patients suffering from acute coronary syndrome (ACS)

  Up to 72 hours

Study Arms (2)

Study group (with CS)

A population of patients acquired from multiple national registries aged \> 18 years, admitted for ACS without CS and proceeding to coronary angiography who developed cardiogenic shock (CS).

Control group (without CS)

A population of patients acquired from multiple national registries aged \> 18 years, admitted for ACS without CS and proceeding to coronary angiography who did not develop cardiogenic shock (CS).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with at least one ICD9 diagnosis code:
• : various versions of Acute myocardial infarction
• : Other acute and subacute forms of ischemic heart disease, other
• : Other and unspecified angina pectoris
• Patients with at least one ICD9 diagnosis code:
• : Cardiogenic shock
• : Shock, unspecified
• Patients with at least one ICD9 procedures codes:
• : Percutaneous transluminal coronary angioplasty \[PTCA\]
• : Intracoronary artery thrombolytic infusion
• : Insertion of non-drug-eluting coronary artery stent(s)
• : Insertion of drug-eluting coronary artery stent(s)
• : Other removal of coronary artery obstruction
• : Coronary arteriography using a single catheter
• : Coronary arteriography using two catheters

You may not qualify if:

• \. Patients without ICD9 diagnosis codes:
• : Cardiogenic shock
• : Shock, unspecified

Sponsors & Collaborators

• Premedix Academy: lead

Study Sites (1)

Premedix Academy

Bratislava, 81102, Slovakia

Location

Related Links

• STOP SHOCK website

MeSH Terms

Conditions

Shock, Cardiogenic; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Allan Böhm, MD, PhD, MBA, FESC, FJCS

  Premedix Academy, Medena 18, 81102 Bratislava, Slovakia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 7, 2022
• Study Start: October 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 7, 2022

Record last verified: 2022-10

Locations

SL (1)