Optimizing risk prediction after a heart attack (ORACLE)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

ORACLE is an observational study enrolling patients hospitalized for myocardial infarction who undergo invasive management and meet predefined high‑risk criteria. The study collects multidimensional data including wearable device signals, blood biomarkers, behavioral patterns, and non‑invasive imaging, linked to clinical outcomes. Advanced machine learning and AI will be applied to discover 'computational biomarkers' that predict future ischemic and bleeding events occurring in or out of hospital. The aim is to improve current risk scores and support safer, more personalized long‑term antithrombotic decisions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* Age \< 18 years
* Low life expectancy (\<1 year)
* Pregnant or breastfeeding women
* 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

Where it's running

• Hospital Universitario Virgen de la Victoria
  Málaga, Málaga, Spain Recruiting

Study contacts

• Study coordinator: Dr. Francesco Costa
• Email: dottfrancescocosta@gmail.com
• Phone: +34

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.