DyslipidemiaNCT07412457
Guideline Adherence in Dyslipidemia With Clinical Decision Support
An observational study of Dyslipidemia and Coronary Artery Disease, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
Objective: To validate the performance of the developed clinical decision support system (CDSS) for participants with lipid metabolism disorders based on a decision tree algorithm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidemia, Coronary Artery Disease, Atherosclerosis of Major Arteries
- How many people
- 500 participants
- Where
- 1 siteRussia
- Study dates
- 1 Apr 2026to 30 Sep 2027
- 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: The data of 500 patients will be structured and entered into an electronic form, which serves as the basis for a clinical decision support system implemented in the form of a decision tree algorithm. This system will be used exclusively for analytical purposes and make it possible to determine the indications for prescribing lipid-lowering therapy, its recommended intensity, and the need to adjust drug doses in accordance with current clinical guidelines.
Who may be able to join
- Availability of the required amount of patient data for completion of the questionnaire-based system;
- Age 18 years or older;
- Signed informed consent to participate in the study.
- Non-inclusion criteria:
- Patients with insufficient data to complete the questionnaire;
- Refusal to sign informed consent for participation in the study.
Who cannot join
- Absence of a consensus opinion on the clinical case among two of the three experts.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of Adherence to Clinical Practice Guidelines in Patients With Dyslipidemia Using a Clinical Decision Support System
Objective: To validate the performance of the developed clinical decision support system (CDSS) for participants with lipid metabolism disorders based on a decision tree algorithm.
Materials and Methods: A clinical decision support system for participants with lipid profile abnormalities will be developed using the Orbeon open-source online form creation platform based on current clinical guidelines.
Read more
During the CDSS pilot implementation, the electronic medical records (EMRs) of 500 participants from the Institute of Personalized Cardiology of the Biomedical Science and Technology Park at Sechenov University will be analyzed.
Retrospective data on prescribed lipid-lowering therapy extracted from the EHR will be compared with the CDSS recommendations. The accuracy of the decisions will be assessed by three independent experts based on digitized clinical and laboratory patient profiles.
The primary endpoint of the study will be to determine the accuracy of the system.
Results: This study will result in the development (creation) and pilot application of the CDSS program in participants with dyslipidemia in real clinical practice.
Conclusion: The developed CDSS system for dyslipidemia will significantly reduce the time required for clinical decision-making and help avoid errors in the interpretation of patient data.
Read the detailed description
This study was conducted as a retrospective observational study and was aimed at developing and applying a decision support system for physicians treating patients with lipid metabolism disorders based on a decision tree algorithm as well as to assess the degree of compliance with clinical guidelines for the management of patients with dyslipidemia in real clinical practice.
As part of the study, a retrospective analysis of the electronic medical records of adult participants will be conducted. Clinical data will be extracted from medical records, including demographic characteristics, laboratory lipid profile indicators (total cholesterol, low- and high-density lipoprotein cholesterol, triglycerides), kidney function indicators (creatinine level and estimated glomerular filtration rate), biochemical parameters, including alanine aminotransferase and creatine phosphokinase levels, as well as information on concomitant and past diseases.
The data of 500 participants will be structured and entered into an electronic form, which serves as the basis for a clinical decision support system implemented in the form of a decision tree algorithm. This system will be used exclusively for analytical purposes and make it possible to determine the indications for prescribing lipid-lowering therapy, its recommended intensity, and the need to adjust drug doses in accordance with current clinical guidelines.
The lipid-lowering therapy prescriptions actually administered by treating physicians and recorded in medical records will be compared with the recommendations generated by the clinical decision support system. An independent expert assessment will be conducted. An expert group consisting of three physicians will form their own recommendations for therapy based on each patients' clinical data, without having access to information about the actual prescriptions and the results of the algorithm, which ensured a blinded assessment of the endpoints.
Immediately after all patients have completed the questionnaire, two independent expert opinions will also be obtained for each patient. Then, by comparing the decisions of the attending physicians, the recommendations of the clinical decision support system, and the conclusions of the expert group, the degree of compliance of actual clinical practice with current clinical guidelines for the management of patients with dyslipidemia will be assessed.
The patient's personal data (surname, first name, patronymic, date of birth, contact details) will not be transferred. Each patient is assigned an individual number that is not linked to their personal data.
A web interface was developed based on a decision tree compiled from several current guidelines. A questionnaire was created for entering anonymized patient data. The system's output is a cardiovascular risk assessment or recommendations for lipid-lowering therapy.
Following clinical guidelines were used:
- Clinical Practice Guidelines - Lipid Metabolism Disorders. Approved by the Ministry of Health of the Russian Federation, 2023.
- ESC/EAS Guidelines for the Treatment of Dyslipidemias: Lipid Modification for Reducing Cardiovascular Risk, 2019.
- ESC/EOAS Guidelines for the Treatment of Patients with Arterial Hypertension, 2018.
- Arterial Hypertension in Adults. Approved by the Ministry of Health of the Russian Federation, 2024.
- Stable Ischemic Heart Disease. Approved by the Ministry of Health of the Russian Federation, 2024.
- ESC Guidelines for the Diagnosis and Treatment of Chronic Coronary Syndrome, 2019.
- ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure, 2021.
- Chronic Heart Failure. Approved by the Ministry of Health of the Russian Federation, 2024.
- Chronic Kidney Disease (CKD). Approved by the Ministry of Health of the Russian Federation, 2024.
- Clinical guidelines for non-alcoholic fatty liver disease. Approved by the Ministry of Health of the Russian Federation, 2023.
A statistical analysis will be conducted on the prevalence and nature of medical errors in the EXСEL system (descriptive statistics). No comparative analysis will be conducted. The parameters of the accuracy of the CDSS will be determined using a four-field table method.
The reference in this study is the decision of two of the three or all three experts on the correctness of the cardiovascular risk assessment, the correctness of the prescription of drug therapy, the correctness of the recommended diet and physical exercise, the correctness of patient monitoring (repeated blood tests, timely completion of examinations).
- Conditions
- Dyslipidemia, Coronary Artery Disease, Atherosclerosis of Major Arteries, Cardiovascular Risk, Subclinical Atherosclerosis
- Keywords
- dyslipidemia, atherosclerosis, revascularization, cardiovascular risk
- Medical subject headings
- Dyslipidemias, Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| General cohort | 500 patients will be structured and entered into an electronic form, which serves as the basis for a clinical decision support system implemented in the form of a decision tree algorithm. This system will be used exclusively for analytical purposes and make it possible to determine the indications for prescribing lipid-lowering therapy, its recommended intensity, and the need to adjust drug doses in accordance with current clinical guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical error in the interpretation of cardiovascular risk
The number and type of incorrect interpretation of a patient's cardiovascular risk by a physician will be determined by three independent experts in comparison with the results of the medical decision support system
Measured: At the end of the study: on average, 1.5 years
Medical error in prescribing lipid-lowering therapy
The number and type of incorrect prescribing lipid-lowering by a physician will be determined by three independent experts in comparison with the results of the medical decision support system
Measured: At the end of the study: on average, 1.5 years
Errors frequency in the functioning of the developed medical decision support system compared to the decision of three independent experts
Errors frequency in the functioning of the developed medical decision support system will be determined when compared to the decision of three independent experts
Measured: At the end of the study: on average, 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412457
- Sponsor's protocol ID
- ChPSH22262
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not possible to provide documentation due to the prohibition received from the local ethics committee
Publications
Evaluation of the effectiveness of lipid-lowering therapy in real clinical practice / N. O. Kuznetsova, F. E. Mamedzade, M. A. Podyanov [et al.] // Doctor.Ru. - 2024. - Vol. 23, No. 8. - Pp. 41-46. - DOI 10.31550/1727-2378-2024-23-8-41-46. - EDN ANFDYI
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Adherence to Clinical Practice Guidelines in Patients With Dyslipidemia Using a Clinical Decision Support System
- ClinicalTrials.gov ID
- NCT07412457
- Acronym / sponsor ID
- ChPSH22262
- Conditions
- Dyslipidemia, Coronary Artery Disease, Atherosclerosis of Major Arteries, Cardiovascular Risk, Subclinical Atherosclerosis
- Keywords
- dyslipidemia, atherosclerosis, revascularization, cardiovascular risk
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: To validate the performance of the developed clinical decision support system (CDSS) for participants with lipid metabolism disorders based on a decision tree algorithm.
Materials and Methods: A clinical decision support system for participants with lipid profile abnormalities will be developed using the Orbeon open-source online form creation platform based on current clinical guidelines.
During the CDSS pilot implementation, the electronic medical records (EMRs) of 500 participants from the Institute of Personalized Cardiology of the Biomedical Science and Technology Park at Sechenov University will be analyzed.
Retrospective data on prescribed lipid-lowering therapy extracted from the EHR will be compared with the CDSS recommendations. The accuracy of the decisions will be assessed by three independent experts based on digitized clinical and laboratory patient profiles.
The primary endpoint of the study will be to determine the accuracy of the system.
Results: This study will result in the development (creation) and pilot application of the CDSS program in participants with dyslipidemia in real clinical practice.
Conclusion: The developed CDSS system for dyslipidemia will significantly reduce the time required for clinical decision-making and help avoid errors in the interpretation of patient data.
Detailed description
This study was conducted as a retrospective observational study and was aimed at developing and applying a decision support system for physicians treating patients with lipid metabolism disorders based on a decision tree algorithm as well as to assess the degree of compliance with clinical guidelines for the management of patients with dyslipidemia in real clinical practice.
As part of the study, a retrospective analysis of the electronic medical records of adult participants will be conducted. Clinical data will be extracted from medical records, including demographic characteristics, laboratory lipid profile indicators (total cholesterol, low- and high-density lipoprotein cholesterol, triglycerides), kidney function indicators (creatinine level and estimated glomerular filtration rate), biochemical parameters, including alanine aminotransferase and creatine phosphokinase levels, as well as information on concomitant and past diseases.
The data of 500 participants will be structured and entered into an electronic form, which serves as the basis for a clinical decision support system implemented in the form of a decision tree algorithm. This system will be used exclusively for analytical purposes and make it possible to determine the indications for prescribing lipid-lowering therapy, its recommended intensity, and the need to adjust drug doses in accordance with current clinical guidelines.
The lipid-lowering therapy prescriptions actually administered by treating physicians and recorded in medical records will be compared with the recommendations generated by the clinical decision support system. An independent expert assessment will be conducted. An expert group consisting of three physicians will form their own recommendations for therapy based on each patients' clinical data, without having access to information about the actual prescriptions and the results of the algorithm, which ensured a blinded assessment of the endpoints.
Immediately after all patients have completed the questionnaire, two independent expert opinions will also be obtained for each patient. Then, by comparing the decisions of the attending physicians, the recommendations of the clinical decision support system, and the conclusions of the expert group, the degree of compliance of actual clinical practice with current clinical guidelines for the management of patients with dyslipidemia will be assessed.
The patient's personal data (surname, first name, patronymic, date of birth, contact details) will not be transferred. Each patient is assigned an individual number that is not linked to their personal data.
A web interface was developed based on a decision tree compiled from several current guidelines. A questionnaire was created for entering anonymized patient data. The system's output is a cardiovascular risk assessment or recommendations for lipid-lowering therapy.
Following clinical guidelines were used:
- Clinical Practice Guidelines - Lipid Metabolism Disorders. Approved by the Ministry of Health of the Russian Federation, 2023.
- ESC/EAS Guidelines for the Treatment of Dyslipidemias: Lipid Modification for Reducing Cardiovascular Risk, 2019.
- ESC/EOAS Guidelines for the Treatment of Patients with Arterial Hypertension, 2018.
- Arterial Hypertension in Adults. Approved by the Ministry of Health of the Russian Federation, 2024.
- Stable Ischemic Heart Disease. Approved by the Ministry of Health of the Russian Federation, 2024.
- ESC Guidelines for the Diagnosis and Treatment of Chronic Coronary Syndrome, 2019.
- ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure, 2021.
- Chronic Heart Failure. Approved by the Ministry of Health of the Russian Federation, 2024.
- Chronic Kidney Disease (CKD). Approved by the Ministry of Health of the Russian Federation, 2024.
- Clinical guidelines for non-alcoholic fatty liver disease. Approved by the Ministry of Health of the Russian Federation, 2023.
A statistical analysis will be conducted on the prevalence and nature of medical errors in the EXСEL system (descriptive statistics). No comparative analysis will be conducted. The parameters of the accuracy of the CDSS will be determined using a four-field table method.
The reference in this study is the decision of two of the three or all three experts on the correctness of the cardiovascular risk assessment, the correctness of the prescription of drug therapy, the correctness of the recommended diet and physical exercise, the correctness of patient monitoring (repeated blood tests, timely completion of examinations).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General cohort | – | –500 patients will be structured and entered into an electronic form, which serves as the basis for a clinical decision support system implemented in the form of a decision tree algorithm. This system will be used exclusively for analytical purposes and make it possible to determine the indications for prescribing lipid-lowering therapy, its recommended intensity, and the need to adjust drug doses in accordance with current clinical guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The data of 500 patients will be structured and entered into an electronic form, which serves as the basis for a clinical decision support system implemented in the form of a decision tree algorithm. This system will be used exclusively for analytical purposes and make it possible to determine the indications for prescribing lipid-lowering therapy, its recommended intensity, and the need to adjust drug doses in accordance with current clinical guidelines.
Key inclusion criteria (6 listed)
- Availability of the required amount of patient data for completion of the questionnaire-based system;
- Age 18 years or older;
- Signed informed consent to participate in the study.
- Patients with insufficient data to complete the questionnaire;
- Refusal to sign informed consent for participation in the study.
Key exclusion criteria (1 listed)
- Absence of a consensus opinion on the clinical case among two of the three experts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Medical error in the interpretation of cardiovascular risk
Time frame: At the end of the study: on average, 1.5 years
The number and type of incorrect interpretation of a patient's cardiovascular risk by a physician will be determined by three independent experts in comparison with the results of the medical decision support system
Medical error in prescribing lipid-lowering therapy
Time frame: At the end of the study: on average, 1.5 years
The number and type of incorrect prescribing lipid-lowering by a physician will be determined by three independent experts in comparison with the results of the medical decision support system
Errors frequency in the functioning of the developed medical decision support system compared to the decision of three independent experts
Time frame: At the end of the study: on average, 1.5 years
Errors frequency in the functioning of the developed medical decision support system will be determined when compared to the decision of three independent experts
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- BackgroundEvaluation of the effectiveness of lipid-lowering therapy in real clinical practice / N. O. Kuznetsova, F. E. Mamedzade, M. A. Podyanov [et al.] // Doctor.Ru. - 2024. - Vol. 23, No. 8. - Pp. 41-46. - DOI 10.31550/1727-2378-2024-23-8-41-46. - EDN ANFDYI
- Individual participant dataSharing planned: No. It is not possible to provide documentation due to the prohibition received from the local ethics committee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemia and Coronary Artery Disease, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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 6 inclusion and 1 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: opening soon, as of the sponsor's last update on 24 Feb 2026. 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 Russia. 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 Peter Chomakhidze, Professor (+79166740369, chomakhidze_p_sh@staff.sechenov.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical error in the interpretation of cardiovascular risk (time frame: At the end of the study: on average, 1.5 years). The study lists 3 primary outcomes in all. 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 NCT07412457, which also lists 1 linked publication.
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 24 Feb 2026.