Optimize Risk Prediction After Myocardial Infarction: The ORACLE Study

Официальное название

Optimize Risk Prediction After Myocardial Infarction Through Artificial Intelligence and Multidimensional Evaluation: The ORACLE Study

Обзор

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.

Вмешательства

• Другое 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 leve

Первичные конечные точки

• Frequency and severity of bleeding and ischemic events [Срок оценки: 8 months inclusion and 12 months follow-up after end of study]

Вторичные конечные точки (1)

• Number of death, stroke, recurrent MI, stent thrombosis, heart failure, hospitalization [Срок оценки: 8 months inclusion and 12 months follow-up after end of study]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 1 центр

• Hospital Universitario Virgen de la Victoria — Málaga

Публикации

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• Baber U, Mehran R, Giustino G, Cohen DJ, Henry TD, Sartori S, Ariti C, Litherland C, Dangas G, Gibson CM, Krucoff MW, Moliterno DJ, Kirtane AJ, Stone GW, Colombo A, Chieffo A, Kini AS, Witzenbichler B, Weisz G, Steg PG, Pocock S. Coronary Thrombosis and Major Bleeding After PCI With Drug-Eluting Stents: Risk Scores From PARIS. J Am Coll Cardiol. 2016 May 17;67(19):2224-2234. doi: 10.1016/j.jacc.20 PMID 27079334

Идентификаторы

NCT: NCT06993415 · ORACLE · ERC-2023-STG-101117469

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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