Optimize Risk Prediction After Myocardial Infarction: The ORACLE Study

NCT06993415 | Recruiting

• 2 other identifiers: ORACLEERC-2023-STG-101117469
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myocardial Infarction (MI)

Keywords

Myocardial Infarction (MI); Risk prediction; Artificial Intelligence; ORACLE study; Computational Biomarkers; Ischemic Events; Bleeding Events; Prospective Observational Study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of death, stroke, recurrent MI, stent thrombosis, heart failure, hospitalization

  8 months inclusion and 12 months follow-up after end of study

Other Outcomes (1)

• Quality life and adherence to treatment

  8 months inclusion and 12 months follow-up after end of study

Study Arms (1)

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

Interventions

data collection OTHER

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.

Also known as: Data collection from biological samples, wearable devices and tests

Myocardial infarction (MI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Hospital Universitario Virgen de la Victoria

Málaga, Málaga, 29010, Spain

RECRUITING

Related Publications (31)

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Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and urine samples for biomarker testing

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Data Collection; Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Electrical Equipment and Supplies; Equipment and Supplies

Central Study Contacts

Dr. Francesco Costa

CONTACT

+34; dottfrancescocosta@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 28, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)