NCT07412457|Not Yet Recruiting
Guideline Adherence in Dyslipidemia With Clinical Decision Support
Assessment of Adherence to Clinical Practice Guidelines in Patients With Dyslipidemia Using a Clinical Decision Support System
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Assessment of Adherence to Clinical Practice Guidelines in Patients With Dyslipidemia Using a Clinical Decision Support System
Sponsor study identifier
observational
500
1 country
1
Study Start
April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 9, 2026
Actual (reported)February 17, 2026
Actual (reported)April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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
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
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.
1 University Hospital
Moscow, 119435, Russia
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
First Submitted
February 9, 2026
First Posted
February 17, 2026
Study Start
April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 30, 2027
EstimatedOne-Dimensional Mathematical Model-Based Automated Assessment of Fractional Flow Reserve
Errors frequency in the functioning of the developed medical decision support system will be determined when compared to the decision of three independent experts
At the end of the study: on average, 1.5 years
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 24, 2026
Record last verified: 2026-02
It is not possible to provide documentation due to the prohibition received from the local ethics committee
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