NCT06993415Recruiting
Optimize Risk Prediction After Myocardial Infarction: The ORACLE Study
Optimize Risk Prediction After Myocardial Infarction Through Artificial Intelligence and Multidimensional Evaluation: The ORACLE Study
Source: ClinicalTrials.gov · Last updated 10 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 750 (estimated)
- First submitted
- 12 May 2025
- Start date
- 1 Jun 2025
- Primary completion date
- 29 Feb 2028
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Diseases
- Coronary artery disease
- NCT number
- NCT06993415
What you commit to
- Study type: Observational
- Planned participants: 750
- From 1 Jun 2025 to the primary completion date, 29 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Age
- Age \< 18 years
Other
- Low life expectancy (\<1 year)
- Pregnant or breastfeeding women
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
Related publications
- Continuous glucose monitoring trajectories in patients with acute coronary syndrome.Cardiovasc Diabetol · 2026 · PMID 42010565
This page is information, not medical advice. Discuss any trial with your doctor.