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Myocardial Infarction (MI)ORACLENCT06993415

Optimize Risk Prediction After Myocardial Infarction: The ORACLE Study

An observational study of Myocardial Infarction (MI), run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Infarction (MI)
What is being tested?
data collection
Type of treatment
Pill or oral medicine
How many people
750 participants
Where
1 siteSpain
Study dates
Jun 2025to Feb 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dr. Francesco Costa contact

+34

dottfrancescocosta@gmail.com

Spain1 site, 1 recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, Málaga, 29010

    Francesco Costa, MD, +34951030435, dottfrancescocosta@gmail.com

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Being tested
data collection
Keywords
Myocardial Infarction (MI), Risk prediction, Artificial Intelligence, ORACLE study, Computational Biomarkers, Ischemic Events, Bleeding Events, Prospective Observational Study
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • data collectionOther

    Also called Data collection from biological samples, wearable devices and tests

    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.

Study groups in NCT06993415
Study groupRoleWhat they receive
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)
Receives: Other: data collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)

  1. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2025
  2. Study startJun 2025 (estimated)
  3. Primary completionFeb 2028 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
750 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06993415
Sponsor's protocol ID
ORACLE
Other IDs
ERC-2023-STG-101117469
Acronym
ORACLE
Status last verified
Jun 2025
First submitted
12 May 2025
Last updated
10 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. No abstract available.

    PubMed 26673558

  • 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.

    PubMed 28886622

  • Simonsson M, Wallentin L, Alfredsson J, Erlinge D, Hellstrom Angerud K, Hofmann R, Kellerth T, Lindhagen L, Ravn-Fischer A, Szummer K, Ueda P, Yndigegn T, Jernberg T. Temporal trends in bleeding events in acute myocardial infarction: insights from the SWEDEHEART registry. Eur Heart J. 2020 Feb 14;41(7):833-843. doi: 10.1093/eurheartj/ehz593.

    PubMed 31504404

  • Valgimigli M, Costa F, Lokhnygina Y, Clare RM, Wallentin L, Moliterno DJ, Armstrong PW, White HD, Held C, Aylward PE, Van de Werf F, Harrington RA, Mahaffey KW, Tricoci P. Trade-off of myocardial infarction vs. bleeding types on mortality after acute coronary syndrome: lessons from the Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRACER) randomized trial. Eur Heart J. 2017 Mar 14;38(11):804-810. doi: 10.1093/eurheartj/ehw525.

    PubMed 28363222

  • Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, Granger CB, Lange RA, Mack MJ, Mauri L, Mehran R, Mukherjee D, Newby LK, O'Gara PT, Sabatine MS, Smith PK, Smith SC Jr. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2016 Sep 6;68(10):1082-115. doi: 10.1016/j.jacc.2016.03.513. Epub 2016 Mar 29. No abstract available.

    PubMed 27036918

  • Fox KA, Dabbous OH, Goldberg RJ, Pieper KS, Eagle KA, Van de Werf F, Avezum A, Goodman SG, Flather MD, Anderson FA Jr, Granger CB. Prediction of risk of death and myocardial infarction in the six months after presentation with acute coronary syndrome: prospective multinational observational study (GRACE). BMJ. 2006 Nov 25;333(7578):1091. doi: 10.1136/bmj.38985.646481.55. Epub 2006 Oct 10.

    PubMed 17032691

  • Subherwal S, Bach RG, Chen AY, Gage BF, Rao SV, Newby LK, Wang TY, Gibler WB, Ohman EM, Roe MT, Pollack CV Jr, Peterson ED, Alexander KP. Baseline risk of major bleeding in non-ST-segment-elevation myocardial infarction: the CRUSADE (Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the ACC/AHA Guidelines) Bleeding Score. Circulation. 2009 Apr 14;119(14):1873-82. doi: 10.1161/CIRCULATIONAHA.108.828541. Epub 2009 Mar 30.

    PubMed 19332461

  • 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.2016.02.064. Epub 2016 Apr 11.

    PubMed 27079334

  • Costa F, van Klaveren D, James S, Heg D, Raber L, Feres F, Pilgrim T, Hong MK, Kim HS, Colombo A, Steg PG, Zanchin T, Palmerini T, Wallentin L, Bhatt DL, Stone GW, Windecker S, Steyerberg EW, Valgimigli M; PRECISE-DAPT Study Investigators. Derivation and validation of the predicting bleeding complications in patients undergoing stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) score: a pooled analysis of individual-patient datasets from clinical trials. Lancet. 2017 Mar 11;389(10073):1025-1034. doi: 10.1016/S0140-6736(17)30397-5.

    PubMed 28290994

  • 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.

    PubMed 31785951

  • 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.

    PubMed 32354228

  • 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.

    PubMed 30545256

  • 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.

    PubMed 30598387

  • Kawashima H, Gao C, Takahashi K, Tomaniak M, Ono M, Hara H, Wang R, Chichareon P, Suryapranata H, Walsh S, Cotton J, Koning R, Rensing B, Wykrzykowska J, de Winter RJ, Garg S, Anderson R, Hamm C, Steg PG, Onuma Y, Serruys PW. Comparative Assessment of Predictive Performance of PRECISE-DAPT, CRUSADE, and ACUITY Scores in Risk Stratifying 30-Day Bleeding Events. Thromb Haemost. 2020 Jul;120(7):1087-1095. doi: 10.1055/s-0040-1712449. Epub 2020 Jun 22.

    PubMed 32572864

  • D'Ascenzo F, De Filippo O, Gallone G, Mittone G, Deriu MA, Iannaccone M, Ariza-Sole A, Liebetrau C, Manzano-Fernandez S, Quadri G, Kinnaird T, Campo G, Simao Henriques JP, Hughes JM, Dominguez-Rodriguez A, Aldinucci M, Morbiducci U, Patti G, Raposeiras-Roubin S, Abu-Assi E, De Ferrari GM; PRAISE study group. Machine learning-based prediction of adverse events following an acute coronary syndrome (PRAISE): a modelling study of pooled datasets. Lancet. 2021 Jan 16;397(10270):199-207. doi: 10.1016/S0140-6736(20)32519-8.

    PubMed 33453782

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Infarction (MI), run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dr. Francesco Costa (+34, dottfrancescocosta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and severity of bleeding and ischemic events (time frame: 8 months inclusion and 12 months follow-up after end of study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06993415, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.

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