Optimize Risk Prediction After Myocardial Infarction: The ORACLE Study (ORACLE)

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction (MI)
• Intervention / Treatment: Other: data collection

• Study Type: Observational
• Enrollment (Estimated): 750

Contacts and Locations

• Study Contact: Name: Dr. Francesco Costa; Phone Number: +34; Email: dottfrancescocosta@gmail.com

Study Locations

• Spain
  • Málaga, Spain, 29010
    • Recruiting
    • Hospital Universitario Virgen de la Victoria
    • Contact: Francesco Costa, MD; Phone Number: +34951030435; Email: dottfrancescocosta@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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)

Other: 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 Names: Data collection from biological samples, wearable devices and tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and severity of bleeding and ischemic events	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.	8 months inclusion and 12 months follow-up after end of study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of death, stroke, recurrent MI, stent thrombosis, heart failure, hospitalization	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.	8 months inclusion and 12 months follow-up after end of study

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality life and adherence to treatment	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	8 months inclusion and 12 months follow-up after end of study

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Collaborators: European Research Council

Publications and helpful links

General Publications

• Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Juni P, Kastrati A, Kolh P, Mauri L, Montalescot G, Neumann FJ, Petricevic M, Roffi M, Steg PG, Windecker S, Zamorano JL, Levine GN; ESC Scientific Document Group; ESC Committee for Practice Guidelines (CPG); ESC National Cardiac Societies. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2018 Jan 14;39(3):213-260. doi: 10.1093/eurheartj/ehx419. No abstract available.
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• Bianco M, D'ascenzo F, Raposeiras Roubin S, Kinnaird T, Peyracchia M, Ariza-Sole A, Cerrato E, Manzano-Fernandez S, Gravinese C, Templin C, Destefanis P, Velicki L, Luciano A, Xanthopoulou I, Rinaldi M, Rognoni A, Varbella F, Boccuzzi G, Omede P, Montabone A, Bernardi A, Taha S, Rossini R, Durante A, Gili S, Magnani G, Autelli M, Grosso A, Blanco PF, Giustetto C, Garay A, Quadri G, Queija BC, Srdanovic I, Paz RC, Fernandez MC, Pousa IM, Gallo D, Morbiducci U, Dominguez-Rodriguez A, Lopez-Cuenca A, Cequier A, Alexopoulos D, Iniguez-Romo A, Pozzi R, Assi EA, Valgimigli M. Comparative external validation of the PRECISE-DAPT and PARIS risk scores in 4424 acute coronary syndrome patients treated with prasugrel or ticagrelor. Int J Cardiol. 2020 Feb 15;301:200-206. doi: 10.1016/j.ijcard.2019.11.132. Epub 2019 Nov 22.
• Choi KH, Song YB, Lee JM, Park TK, Yang JH, Choi JH, Choi SH, Oh JH, Cho DK, Lee JB, Doh JH, Kim SH, Jeong JO, Bae JH, Kim BO, Cho JH, Suh IW, Kim DI, Park HK, Park JS, Choi WG, Lee WS, Gwon HC, Hahn JY. Clinical Usefulness of PRECISE-DAPT Score for Predicting Bleeding Events in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: An Analysis From the SMART-DATE Randomized Trial. Circ Cardiovasc Interv. 2020 May;13(5):e008530. doi: 10.1161/CIRCINTERVENTIONS.119.008530. Epub 2020 May 1.
• Choi SY, Kim MH, Cho YR, Sung Park J, Min Lee K, Park TH, Yun SC. Performance of PRECISE-DAPT Score for Predicting Bleeding Complication During Dual Antiplatelet Therapy. Circ Cardiovasc Interv. 2018 Dec;11(12):e006837. doi: 10.1161/CIRCINTERVENTIONS.118.006837.
• Yoshida R, Ishii H, Morishima I, Tanaka A, Morita Y, Takagi K, Yoshioka N, Hirayama K, Iwakawa N, Tashiro H, Kojima H, Mitsuda T, Hitora Y, Furusawa K, Tsuboi H, Murohara T. Performance of HAS-BLED, ORBIT, PRECISE-DAPT, and PARIS risk score for predicting long-term bleeding events in patients taking an oral anticoagulant undergoing percutaneous coronary intervention. J Cardiol. 2019 Jun;73(6):479-487. doi: 10.1016/j.jjcc.2018.10.013. Epub 2018 Dec 28.
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Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: May 12, 2025
• First Submitted That Met QC Criteria: May 20, 2025
• First Posted (Actual): May 28, 2025

Study Record Updates

• Last Update Posted (Actual): June 10, 2025
• Last Update Submitted That Met QC Criteria: June 4, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Risk prediction; Myocardial Infarction (MI); Bleeding Events; Prospective Observational Study; ORACLE study; Computational Biomarkers; Ischemic Events
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Myocardial Ischemia; Ischemia; Myocardial Infarction; Infarction
• Other Study ID Numbers: ORACLE; ERC-2023-STG-101117469 (Other Identifier: European Research Council (ERC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No