Artificial Intelligence for Automated Clinical Data Exploration From Electronic Medical Records (CardioMining-AI)

NCT ID: NCT05176769

Last Updated: 2025-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-14

Study Completion Date

2026-03-01

Brief Summary

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The purpose of this study is to highlight the usefulness of artificial intelligence and machine learning to develop computer algorithms that will achieve with great reliability, speed and accuracy the automatic extraction and processing of large volumes of raw and unstructured clinical data from electronic medical files.

Detailed Description

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Despite the rapid development of medicine and computer science in recent years, the medical treatment in modern clinical practice is often empirical and based on retrospective data. With the growing number of patients and their concentration in large tertiary centers, it becomes attractive to systematically collect clinical data and apply them to risk stratification models. However, with the increasing volume of data, manual data collection and processing becomes a challenge, as this approach is time consuming and costly for the healthcare systems. In addition, unstructured information, such as clinical notes, are very often written as free text that is unsuitable for direct analysis. The use of artificial intelligence is very promising and is going to rapidly change the future of medicine in the upcoming years. Due to the automated processes it offers, it is possible to quickly and reliably extract data for further processing. The results from its use can be easily extended to different healthcare systems, amplifying the knowledge produced and improving diagnostic and therapeutic accuracy, and ultimately positively affecting health services. Collecting the vast amount of data from different sources without compromising patients' personal data is a major challenge in modern science.

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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Artificial Intelligence Machine Learning Electronic Medical Records

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Hospitalised patients in Cardiology Departments in Greece
* Patients whose medical records are electronically stored in each hospital's computer/information systems

Exclusion Criteria

* Patients that died during hospitalization, and thus no discharge letter was issued
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hippokration Hospital Athens

UNKNOWN

Sponsor Role collaborator

General Hospital of Larissa

OTHER

Sponsor Role collaborator

University Hospital, Alexandroupolis

OTHER

Sponsor Role collaborator

University General Hospital of Patras

OTHER

Sponsor Role collaborator

University General Hospital of Heraklion

OTHER

Sponsor Role collaborator

George Papanicolaou Hospital

OTHER

Sponsor Role collaborator

Ippokrateio General Hospital of Thessaloniki

OTHER

Sponsor Role collaborator

AHEPA University Hospital

OTHER

Sponsor Role lead

Responsible Party

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George Giannakoulas

Associate Professor in Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Cardiology Clinic, Democritus University of Thrace

Alexandroupoli, , Greece

Site Status NOT_YET_RECRUITING

1st Department of Cardiology, Hippokration General Hospital

Athens, , Greece

Site Status RECRUITING

Department of Cardiology, Heraklion University Hospital

Heraklion, , Greece

Site Status NOT_YET_RECRUITING

University General Hospital of Larissa, University of Thessaly

Larissa, , Greece

Site Status RECRUITING

Department of Cardiology, University of Patras Medical School

Pátrai, , Greece

Site Status RECRUITING

1st Cardiology Department, AHEPA University Hospital

Thessaloniki, , Greece

Site Status RECRUITING

3rd Cardiology Department, Hippokration Hospital

Thessaloniki, , Greece

Site Status NOT_YET_RECRUITING

Cardiology Department, George Papanikolaou General Hospital

Thessaloniki, , Greece

Site Status RECRUITING

Laboratory of Medical Physics, Aristotle University of Thessaloniki

Thessaloniki, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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George Giannakoulas, MD, PhD

Role: CONTACT

2310994830 ext. +30

Athanasios Samaras, MD

Role: CONTACT

2310994830 ext. +30

Facility Contacts

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George Chalikias, MD, PhD

Role: primary

George Lazaros, MD, PhD

Role: primary

Alexandros Patrianakos, MD, PhD

Role: primary

Gregory Giamouzis, MD, PhD

Role: primary

Periklis Davlouros, MD, PhD

Role: primary

Athanasios Samaras, MD, PhD

Role: primary

Vassilios Vassilikos, MD, PhD

Role: primary

John Zarifis, MD, PhD

Role: primary

Panagiotis Bamidis, Prof

Role: primary

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.

Reference Type BACKGROUND
PMID: 29880128 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28545640 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30828647 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29888035 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32592755 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30689812 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37012018 (View on PubMed)

Other Identifiers

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545/19.11.2021

Identifier Type: -

Identifier Source: org_study_id

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