Predicting Future Heart Problems and Bleeding After a Heart Attack Using AI
Studies adults after a heart attack, using wearables, blood markers and imaging to predict risk.
Plain-language title generated from the registry record
Registry title: Optimize Risk Prediction After Myocardial Infarction: The ORACLE Study
Key facts
- Where
- Málaga, SpainSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults hospitalised with a heart attack or unstable angina who had invasive treatment and are at high risk of new heart or bleeding events.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Hospitalised for ST-segment elevated or non-ST-segment elevated myocardial infarction, or unstable angina, with invasive management, and at least two high risk criteria, such as age >65 years, diabetes, multivessel disease, chronic kidney disease, prior stroke, prior MI, heart failure or BMI>27.
Main reasons for not taking part
- Age < 18 years
- Low life expectancy (<1 year)
- Pregnant or breastfeeding women
- Non-significant coronary artery disease on coronary angiography (<30% in the left main stem or <50% in the other coronary segments)
- Vulnerable population, unable to read or write, or unable to understand and follow the study procedures, per investigator's judgement
Read by machine on 9 November 2026.
Where in Spain
- Hospital Universitario Virgen de la VictoriaMálaga, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Trial code
- NCT06993415
- Record updated
- 10 June 2025
- Original description
Background. Myocardial infarction (MI) is a leading cause of death worldwide. After MI, longterm antithrombotic therapy is crucial to prevent recurrent events, but increases bleeding, that also impacts morbidity and mortality. Giving these competing risks prediction tools to forecast ischemic and bleeding are of paramount importance to inform clinical decisions, but their current precision is limited. Improve events prediction, by discovering novel and innovative markers of risk would have a tremendous impact on therapeutic decisions and patients' outcome.Read full original descriptionShow less
Optimize Risk Prediction After Myocardial Infarction Through Artificial Intelligence and Multidimensional Evaluation: The ORACLE Study
Background. Myocardial infarction (MI) is a leading cause of death worldwide. After MI, longterm antithrombotic therapy is crucial to prevent recurrent events, but increases bleeding, that also impacts morbidity and mortality. Giving these competing risks prediction tools to forecast ischemic and bleeding are of paramount importance to inform clinical decisions, but their current precision is limited. Improve events prediction, by discovering novel and innovative markers of risk would have a tremendous impact on therapeutic decisions and patients' outcome.
Objectives. Discover novel "computational biomarkers" of risk and improve current standards of risk prediction by using innovative multidimensional information from wearable devices, biomarkers, behavioural patterns and non-invasive imaging, integrated through artificial intelligence computation.
Outcomes. The primary outcomes of interest for this analysis are bleeding and ischemic events occurring in or outside the hospital at longest available follow-up. Bleeding will be categorised according to the Bleeding Academic Research Consortium (BARC) definition. The occurrence of major adverse cardiovascular events (MACE), a composite of cardiovascular death, MI, definite stent thrombosis and stroke will be collected according to the Academic Research Consortium-2 classification.
Inclusion: Patients with Myocardial Infarction (i.e. hospitalization for ST- segment elevated, non-ST-segment elevated myocardial infarction or unstable angina) undergoing invasive management and at high risk of clinical events (i.e. presence of at least two of these high risk criteria: age >65 years, diabetes mellitus, multivessel disease, peripheral artery disease, chronic kidney disease, prior stroke anytime or prior TIA in the last 6 months, prior MI, complex PCI, Prior PCI/CABG, heart failure, BMI>27, anticipated long term use of an oral anticoagulant, haemoglobin less than 11g/dl, spontaneous bleeding requiring hospitalization or transfusion in the past 12 months, bleeding diathesis* active malignancy other than skin, previous spontaneous intracranial hemorrhage); Systemic conditions associated with an increased bleeding risk (e.g. haematological disorders, including a history of or current thrombocytopaenia defined as a platelet count <100,000/mm3 (<100 x 10\^9/L), or any known coagulation disorder associated with increased bleeding risk.
Exclusion: Evidence at coronary angiography of non-significant coronary artery disease (<30% in the left main stem or <50% in the other coronary segments); Subject belongs to a vulnerable population (per investigator's judgment), subject unable to read or write, or other conditions that unable the patient to fully comprehend and comply to the study procedures as per investigator's judgement; Age < 18 years; Low life expectancy (<1 year); Pregnant or breastfeeding women.