Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:26 AM
Study NCT ID:
NCT07412457
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Guideline Adherence in Dyslipidemia With Clinical Decision Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-22', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medical error in the interpretation of cardiovascular risk', 'timeFrame': 'At the end of the study: on average, 1.5 years', 'description': "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"}, {'measure': 'Medical error in prescribing lipid-lowering therapy', 'timeFrame': 'At the end of the study: on average, 1.5 years', 'description': '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'}, {'measure': 'Errors frequency in the functioning of the developed medical decision support system compared to the decision of three independent experts', 'timeFrame': 'At the end of the study: on average, 1.5 years', 'description': 'Errors frequency in the functioning of the developed medical decision support system will be determined when compared to the decision of three independent experts'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dyslipidemia', 'atherosclerosis', 'revascularization', 'cardiovascular risk'], 'conditions': ['Dyslipidemia', 'Coronary Artery Disease', 'Atherosclerosis of Major Arteries', 'Cardiovascular Risk', 'Subclinical Atherosclerosis']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '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'}]}, 'descriptionModule': {'briefSummary': '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.\n\nMaterials 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.\n\nDuring 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.\n\nRetrospective 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.\n\nThe primary endpoint of the study will be to determine the accuracy of the system.\n\nResults: This study will result in the development (creation) and pilot application of the CDSS program in participants with dyslipidemia in real clinical practice.\n\nConclusion: 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.', 'detailedDescription': "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.\n\nAs 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.\n\nThe 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.\n\nThe 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.\n\nImmediately 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.\n\nThe 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.\n\nA 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.\n\nFollowing clinical guidelines were used:\n\n* Clinical Practice Guidelines - Lipid Metabolism Disorders. Approved by the Ministry of Health of the Russian Federation, 2023.\n* ESC/EAS Guidelines for the Treatment of Dyslipidemias: Lipid Modification for Reducing Cardiovascular Risk, 2019.\n* ESC/EOAS Guidelines for the Treatment of Patients with Arterial Hypertension, 2018.\n* Arterial Hypertension in Adults. Approved by the Ministry of Health of the Russian Federation, 2024.\n* Stable Ischemic Heart Disease. Approved by the Ministry of Health of the Russian Federation, 2024.\n* ESC Guidelines for the Diagnosis and Treatment of Chronic Coronary Syndrome, 2019.\n* ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure, 2021.\n* Chronic Heart Failure. Approved by the Ministry of Health of the Russian Federation, 2024.\n* Chronic Kidney Disease (CKD). Approved by the Ministry of Health of the Russian Federation, 2024.\n* Clinical guidelines for non-alcoholic fatty liver disease. Approved by the Ministry of Health of the Russian Federation, 2023.\n\nA 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.\n\nThe 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Availability of the required amount of patient data for completion of the questionnaire-based system;\n2. Age 18 years or older;\n3. Signed informed consent to participate in the study.\n\nNon-inclusion criteria:\n\n1. Patients with insufficient data to complete the questionnaire;\n2. Refusal to sign informed consent for participation in the study.\n\n Exclusion Criteria:\n3. Absence of a consensus opinion on the clinical case among two of the three experts.'}, 'identificationModule': {'nctId': 'NCT07412457', 'briefTitle': 'Guideline Adherence in Dyslipidemia With Clinical Decision Support', 'organization': {'class': 'OTHER', 'fullName': 'I.M. Sechenov First Moscow State Medical University'}, 'officialTitle': 'Assessment of Adherence to Clinical Practice Guidelines in Patients With Dyslipidemia Using a Clinical Decision Support System', 'orgStudyIdInfo': {'id': 'ChPSH22262'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'General cohort', 'description': '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'}]}, 'contactsLocationsModule': {'locations': [{'zip': '119435', 'city': 'Moscow', 'country': 'Russia', 'facility': '1 University Hospital', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Peter Chomakhidze, Professor', 'role': 'CONTACT', 'email': 'chomakhidze_p_sh@staff.sechenov.ru', 'phone': '+79166740369'}, {'name': 'Fidan Mammadzada, Dr.', 'role': 'CONTACT', 'email': 'fidan.mmzada@gmail.com', 'phone': '+79104443454'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'It is not possible to provide documentation due to the prohibition received from the local ethics committee'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'I.M. Sechenov First Moscow State Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}