Optimize Risk Prediction After Myocardial Infarction: The ORACLE Study

• data collection (Other), also known as Data collection from biological samples, wearable devices and tests: The ORACLE program is a prospective, deep phenotyping, study based on multimodal information and artificial intelligence computation. We will prospectively collect in-hospital and out-of-hospital data of a large cohort of patients presenting with MI, including data from wearable devices recording continuous ECG, interstitial-fluids, non-invasive blood pressure and mobility, behavioural patterns from a dedicated mobile application, blood and urine biomarkers and non-invasive imaging. We will leverage on AI, using statistical learning methods and neural networks, to explore patterns and higher order interactions within the data to provide novel "computational biomarkers" of ischemic and bleeding risk.

Primary outcomes

• Frequency and severity of bleeding and ischemic events [8 months inclusion and 12 months follow-up after end of study]: 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.

Secondary outcomes

• Number of death, stroke, recurrent MI, stent thrombosis, heart failure, hospitalization [8 months inclusion and 12 months follow-up after end of study]: Death will be defined as death from cardiovascular causes or cerebrovascular causes and any death without another known cause. Stroke will be defined as an acute new neurological deficit ending in death or lasting >24 hours not due to another readily identifiable cause such as trauma. Recurrent MI is defined according to the fourth universal definition of MI. Stent thrombosis will be classified as definite, probable or possible according to the Academic Research Consortium (ARC) definition. New-onset heart failure requiring re-hospitalisation or unplanned medical contact for heart failure symptoms will be evaluated. Recurrent hospitalization for acute coronary syndrome, unstable angina or clinically-indicated urgent revascularization will also be evaluated.

Other outcomes

• Quality life and adherence to treatment [8 months inclusion and 12 months follow-up after end of study]: Patients' quality of life and adherence to treatment will be evaluated with: * Health mobility and mental scales (i.e. EQ-5D-5L and SF-12v2) * Anginal status according to the Seattle Angina questionnaire (SAQ) * Functional status according to the Kansas City Cardiomiopathy questionnaire (KCCQ) * Modified Borg Dyspnoea Scale

Sex: All, ages: 18 Years to any

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

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