Actively Recruiting
Optimize Risk Prediction After Myocardial Infarction: The ORACLE Study
Led by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Updated on 2025-06-10
750
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
Sponsors
F
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Lead Sponsor
E
European Research Council
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Optimize Risk Prediction After Myocardial Infarction: The ORACLE Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with myocardial infarction or unstable angina hospitalized and undergoing invasive management
- High risk defined by at least two of the following: age >65 years, diabetes, multivessel disease, peripheral artery disease, chronic kidney disease, prior stroke or recent transient ischemic attack, prior myocardial infarction, complex PCI, prior PCI or CABG, heart failure, BMI >27, anticipated long-term oral anticoagulant use, hemoglobin less than 11 g/dl, recent bleeding requiring hospitalization or transfusion, bleeding disorders, active malignancy other than skin cancer, previous spontaneous intracranial hemorrhage
- Systemic conditions increasing bleeding risk such as hematological disorders or thrombocytopenia (platelet count <100,000/mm3) or known coagulation disorders
You will not qualify if you...
- Age less than 18 years
- Life expectancy less than 1 year
- Pregnant or breastfeeding women
- Coronary angiography showing non-significant coronary artery disease (<30% in left main stem or <50% in other segments)
- Vulnerable populations or inability to understand or comply with study procedures as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, Spain, 29010
Actively Recruiting
Research Team
D
Dr. Francesco Costa
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here