Artificial Intelligence Models to Predict Clinically Relevant Cardiovascular Outcomes

NCT06847100 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 273

Last updated 2025-08-26

No results posted yet for this study

Summary

Atrial fibrillation (AF) is a frequent and clinically relevant problem among the events that may occur during the hospitalization period in patients with cardiovascular disease. AF, indeed, is a determinant or aggravating condition of serious adverse events, such as myocardial infarction, heart failure, and thromboembolic stroke. The occurrence of AF in hospitalized patients, such as those admitted for coronary intervention, results in prolonged length of hospitalization, increased likelihood of discharge on anticoagulants, and increased 30-day risk of bleeding. It is noteworthy that while the incidence of AF in the general population is about 1-2 cases per 1000 people per year, this is much higher in patients hospitalized for acute myocardial infarction (AMI) (about 10% over the hospitalization period) or in patients undergoing coronary artery bypass grafting (CABG) (about 25% over the hospitalization period). Thus, identifying patients at high risk of AF during the hospitalization period could allow experimental testing of the efficacy and safety of preventive interventions (e.g., tailored anesthetic or surgical approaches, drug-prevention, etc.). It can be hypothesized that the clinical and nonclinical variables useful in estimating the risk of AF will change depending on the type of patients and that the identification and integration of these variables will require more complex predictive analysis systems than the regression models classically used to develop risk scores.

On the other hand, the risk of recurrence of coronary events throughout the first years after CABG remains high (about 20% at 5 years) despite effective revascularization and early secondary prevention.Although some scores have been developed for estimating the risk of coronary event recurrence in secondary prevention using multivariate regression models, these algorithms consider a limited number of predictors, do not take into account possible interactions between different factors, and their actual predictive ability is not reported in the literature.

With advances in Artificial Intelligence (AI) technology together with the rapid development of digital clinical datasets, machine learning has the potential to analyze substantial amounts of data and recognize patterns to predict AF onset and recurrence of coronary events within a defined time horizon (e.g., in-hospital event) in selected populations in a way that improves the predictive ability of conventional methods.

Conditions

Interventions

DIAGNOSTIC_TEST

Blood withdrawal

Optional collection of 5 mL of blood to assess the contribution of 16 gene polymorphisms AF-associated

Sponsors & Collaborators

  • Tampere University

    collaborator OTHER
  • Politecnico di Milano

    collaborator OTHER
  • Protestant University of Applied Sciences (Ludwigsburg, Germany)

    collaborator UNKNOWN
  • Centro Cardiologico Monzino

    lead OTHER

Principal Investigators

  • Claudio Tondo, MD, PhD · IRCCS Centro Cardiologico Monzino

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-06
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • Finland
  • Germany
  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06847100 on ClinicalTrials.gov