Artificial Intelligence for Automated Clinical Data Exploration From Electronic Medical Records (CardioMining-AI)
NCT ID: NCT05176769
Last Updated: 2025-01-29
Study Results
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Basic Information
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RECRUITING
60000 participants
OBSERVATIONAL
2022-01-14
2026-03-01
Brief Summary
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Detailed Description
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Electronically-registered clinical notes of patients who were hospitalized in the Cardiology ward of tertiary hospitals will be retrospectively collected, as well as additional files such as the laboratory and imaging examinations related to each hospitalization. Given the size of the participating clinics and the years during which the recording of electronic hospital records in electronic form was applied, it is estimated that the sample of patient records will be about 60.000. All information that could potentially be used to identify a person, such as name, ID number, postal code, place of residence, occupation, will be deleted from these electronic files. Only the age will be recorded, not the exact date of birth of each patient. Only the days of hospitalization will be recorded and not the exact dates of admission and discharge from the hospital. Thus, the data will not be able to be assigned to a specific subject, as no additional information or identifiers will be collected for the subjects. After the files are anonymized, each patient's clinical note will be linked with a specific key ("identifier"). The electronic file that contains the correlation of the "identifier" with the patient's clinical note will be stored in a secure hospital electronic location. The fully anonymized files will initially be manually analyzed to extract information into a database containing all of patients' clinical information, such as discharge diagnoses, medications, treatment protocols, laboratory and diagnostic tests. At the same time, a sample (1/3) of the clinical notes will be analyzed to identify the keywords or phrases associated with each diagnosis (for example, the atrial fibrillation diagnosis will probably be recorded as "atrial fibrillation", " AF ", etc.). By using this generated dictionary of keywords and by integrating artificial intelligence methods and text mining, such as natural language processing (NLP), an automated extraction of data and diagnoses from these electronic medical notes will be attempted. The reliability and accuracy of the computational methods will be evaluated internally, comparing the data extracted automatically with those recorded manually. In addition, the reliability and accuracy of these computational methods will be evaluated externally, applying these methods to 2/3 of the clinical notes in which no association between keywords and specific diagnoses was attempted.
Regarding Greece, the present study aims to be the first to analyze the usefulness of artificial intelligence for automated extraction and processing of unstructured clinical data from patients' medical clinical notes. The results of this study will have a positive impact on:
1. the automation of large-scale data analysis and processing procedures
2. the rapid epidemiological recording and utilization of clinical data
3. the early diagnosis of diseases
4. the development of phenotypic patient profiles that could benefit from targeted therapies
5. the development of clinical decision support systems that will provide information about the possible clinical course of patients after hospital discharge and assist medical decisions
6. the development and validation of prognostic models for major cardiovascular diseases
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients whose medical records are electronically stored in each hospital's computer/information systems
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Hippokration Hospital Athens
UNKNOWN
General Hospital of Larissa
OTHER
University Hospital, Alexandroupolis
OTHER
University General Hospital of Patras
OTHER
University General Hospital of Heraklion
OTHER
George Papanicolaou Hospital
OTHER
Ippokrateio General Hospital of Thessaloniki
OTHER
AHEPA University Hospital
OTHER
Responsible Party
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George Giannakoulas
Associate Professor in Cardiology
Locations
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University Cardiology Clinic, Democritus University of Thrace
Alexandroupoli, , Greece
1st Department of Cardiology, Hippokration General Hospital
Athens, , Greece
Department of Cardiology, Heraklion University Hospital
Heraklion, , Greece
University General Hospital of Larissa, University of Thessaly
Larissa, , Greece
Department of Cardiology, University of Patras Medical School
Pátrai, , Greece
1st Cardiology Department, AHEPA University Hospital
Thessaloniki, , Greece
3rd Cardiology Department, Hippokration Hospital
Thessaloniki, , Greece
Cardiology Department, George Papanikolaou General Hospital
Thessaloniki, , Greece
Laboratory of Medical Physics, Aristotle University of Thessaloniki
Thessaloniki, , Greece
Countries
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Central Contacts
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Facility Contacts
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References
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Johnson KW, Torres Soto J, Glicksberg BS, Shameer K, Miotto R, Ali M, Ashley E, Dudley JT. Artificial Intelligence in Cardiology. J Am Coll Cardiol. 2018 Jun 12;71(23):2668-2679. doi: 10.1016/j.jacc.2018.03.521.
Krittanawong C, Zhang H, Wang Z, Aydar M, Kitai T. Artificial Intelligence in Precision Cardiovascular Medicine. J Am Coll Cardiol. 2017 May 30;69(21):2657-2664. doi: 10.1016/j.jacc.2017.03.571.
Madani A, Arnaout R, Mofrad M, Arnaout R. Fast and accurate view classification of echocardiograms using deep learning. NPJ Digit Med. 2018;1:6. doi: 10.1038/s41746-017-0013-1. Epub 2018 Mar 21.
Boag W, Doss D, Naumann T, Szolovits P. What's in a Note? Unpacking Predictive Value in Clinical Note Representations. AMIA Jt Summits Transl Sci Proc. 2018 May 18;2017:26-34. eCollection 2018.
Hashir M, Sawhney R. Towards unstructured mortality prediction with free-text clinical notes. J Biomed Inform. 2020 Aug;108:103489. doi: 10.1016/j.jbi.2020.103489. Epub 2020 Jun 25.
Diller GP, Kempny A, Babu-Narayan SV, Henrichs M, Brida M, Uebing A, Lammers AE, Baumgartner H, Li W, Wort SJ, Dimopoulos K, Gatzoulis MA. Machine learning algorithms estimating prognosis and guiding therapy in adult congenital heart disease: data from a single tertiary centre including 10 019 patients. Eur Heart J. 2019 Apr 1;40(13):1069-1077. doi: 10.1093/eurheartj/ehy915.
Samaras A, Bekiaridou A, Papazoglou AS, Moysidis DV, Tsoumakas G, Bamidis P, Tsigkas G, Lazaros G, Kassimis G, Fragakis N, Vassilikos V, Zarifis I, Tziakas DN, Tsioufis K, Davlouros P, Giannakoulas G; CardioMining Study Group. Artificial intelligence-based mining of electronic health record data to accelerate the digital transformation of the national cardiovascular ecosystem: design protocol of the CardioMining study. BMJ Open. 2023 Apr 3;13(4):e068698. doi: 10.1136/bmjopen-2022-068698.
Other Identifiers
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545/19.11.2021
Identifier Type: -
Identifier Source: org_study_id
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