Optimize Risk Prediction After Myocardial Infarction: The ORACLE Study
NCT ID: NCT06993415
Last Updated: 2025-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
750 participants
OBSERVATIONAL
2025-06-30
2028-02-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Myocardial infarction (MI)
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)
data collection
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.
Interventions
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data collection
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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European Research Council
OTHER
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
OTHER
Responsible Party
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Locations
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Hospital Universitario Virgen de la Victoria
Málaga, Málaga, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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ERC-2023-STG-101117469
Identifier Type: OTHER
Identifier Source: secondary_id
ORACLE
Identifier Type: -
Identifier Source: org_study_id
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