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

The Usefulness of Artificial Intelligence for Automated Extraction and Processing of Clinical Data From Electronic Medical Records (CardioMining-AI)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05176769
Enrollment
60000
Registered
2022-01-04
Start date
2022-01-14
Completion date
2026-03-01
Last updated
2025-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artificial Intelligence, Electronic Medical Records, Machine Learning

Keywords

artificial intelligence, machine learning, medical records, digital health

Brief summary

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

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

Interventions

None listed

Sponsors

Hippokration Hospital Athens
CollaboratorUNKNOWN
General Hospital of Larissa
CollaboratorOTHER
University Hospital, Alexandroupolis
CollaboratorOTHER
University General Hospital of Patras
CollaboratorOTHER
University General Hospital of Heraklion
CollaboratorOTHER
George Papanicolaou Hospital
CollaboratorOTHER
Ippokrateio General Hospital of Thessaloniki
CollaboratorOTHER
AHEPA University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of artificial intelligence to automatically extract clinical data from patients' medical records compared with traditional manual data extraction methods1 yearRate of accurate extraction of clinical data (medical history, discharge diagnoses, medication, etc.) from unstructured clinical notes using automated artificial intelligence methods compared with traditional methods of manual data extraction

Secondary

MeasureTime frameDescription
Time to all-cause mortalityup to 8 years (from hospital discharge until study primary completion date)Length of time (months) until death from any cause during the follow-up period
Time to incident major cardiovascular diseasesup to 8 years (from hospital discharge until study primary completion date)Length of time (months) until development of heart failure, diabetes mellitus or coronary artery disease during the follow-up period
Time to rehospitalization for cardiovascular reasonsup to 8 years (from hospital discharge until study primary completion date)Length of time (months) until rehospitalization for cardiovascular reasons during the follow-up period
Time to stroke or systemic embolismup to 8 years (from hospital discharge until study primary completion date)Length of time (months) until stroke or systemic embolism during the follow-up period
Time to acute coronary syndromeup to 8 years (from hospital discharge until study primary completion date)Length of time (months) until acute coronary syndrome during the follow-up period

Countries

Greece

Contacts

Primary ContactGeorge Giannakoulas, MD, PhD
ggiannakoulas@auth.gr2310994830
Backup ContactAthanasios Samaras, MD
ath.samaras.as@gmail.com2310994830

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026