Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2026-01-03 @ 11:47 PM
Study NCT ID:
NCT04162561
Status:
COMPLETED
Last Update Posted:
2023-03-15
First Post:
2019-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TherApy in stabLe Coronary Artery dIsease Patients According to Clinical GuideliNes (ALIGN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-12', 'studyFirstSubmitDate': '2019-11-11', 'studyFirstSubmitQcDate': '2019-11-11', 'lastUpdatePostDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to life-modifying treatment', 'timeFrame': '1 year', 'description': "The Adherence scale of the Russian National Society of evidence based pharmacotherapy modified for patients with coronary heart disease will be used to assess patients' adherence to treatment. The patients will be asked questions about taking prescribed medications as recommended by a doctor.\n\nThe score system with the min value in the scale 0 and the max value 4 is used for the assessment of the results: 0 - adherent, 1-2 - partially adherent, 3 - partially non-adherent, 4 - non adherent."}, {'measure': 'Achievement of the target LDL-C and BP levels', 'timeFrame': '1 year', 'description': 'Target LDL-C levels - less than 1.8 mmol/l, target BP levels - less than 140/90 mmHg'}], 'secondaryOutcomes': [{'measure': 'all-cause mortality', 'timeFrame': '2 years'}, {'measure': 'Myocardial Infarction', 'timeFrame': '2 years', 'description': 'description - the total number of events'}, {'measure': 'Stroke', 'timeFrame': '2 years', 'description': 'description - the total number of events'}, {'measure': 'Unplanned hospitalization for cardiovascular diseases', 'timeFrame': '2 years', 'description': 'description - the total number of events'}, {'measure': 'Myocardial revascularization', 'timeFrame': '2 years', 'description': 'description - the total number of events'}, {'measure': 'improvement of the functional class of angina in at least 1-grade level', 'timeFrame': '1 year', 'description': 'Assessment of the functional class of angina will be made according to the Canadian Cardiovascular Society grading of angina pectoris'}, {'measure': 'Compliance to life-modifying treatment', 'timeFrame': '1 year', 'description': 'Necessity of the use of the following drugs will be investigated for each patient: antiplatelets, anticoagulants, hypolipidemic drugs, beta-blockers, ACE-inhibitors/ARBs.\n\nLater, percent of the drugs that each patient actually takes will be calculated (for example, three drugs are indicated and two are taken - (2/3)\\*100 = 66.6%).\n\nIn the end, the mean adherence to therapy in the investigated group will be calculated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['quality of therapy', 'current clinical guidelines'], 'conditions': ['Stable Ischemic Heart Disease']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Martsevich S.Yu., Zharkova E.D., Kutishenko N.P., Lukina Yu.V., Tolpygina S.N., Voronina V.P., Zagrebelnyy A.V. An Attempt to Accord the Quality of Therapy of Stable Coronary Heart Disease Patients with Current Clinical Guidelines (ALIGN study): Design and the First Results. Rational Pharmacotherapy in Cardiology. 2020;16(1):75-81. (In Russ.) https://doi.org/10.20996/1819-6446-2020-02-08'}, {'type': 'RESULT', 'citation': 'Martsevich S.Y., Lukina Y.V., Zharkova E.D., Kutishenko N.P. Treatment Adherence to Drug Therapyin Patients with Stable Coronary Artery Disease During the COVID-19 Pandemic. Rational Pharmacotherapy in Cardiology. 2021;17(1):99-104. https://doi.org/10.20996/1819-6446-2021-01-06'}, {'type': 'RESULT', 'citation': 'Zharkova E.D., Martsevich S.Yu., Lukina Yu.V., Kutishenko N.P., Drapkina O.M. Assessment of the Quality of Drug Therapy in Patients with Stable Coronary Artery Disease in the Second Stage of the ALIGN Study. Rational Pharmacotherapy in Cardiology. 2022;18(3):306-310. (In Russ.) https://doi.org/10.20996/1819-6446-2022-06-12'}, {'type': 'RESULT', 'citation': 'Zharkova E.D., Martsevich S.Yu., Lukina Yu.V., Kutishenko N.P., Drapkina O.M. The quality of received drug therapy in patients with stable coronary heart disease according to the ALIGN (TherApy in stabLe Coronary Artery dIsease Patients According to Clinical GuideliNes) study. Cardiovascular Therapy and Prevention. 2022;21(9):3371. (In Russ.) https://doi.org/10.15829/1728-8800-2022-3371'}]}, 'descriptionModule': {'briefSummary': 'The aim of this prospective cohort study is to assess the quality of therapy in patients with stable ischemic heart disease (IHD) who had never applied for specialized medical care for the last 3 years and try to accord their treatment with current clinical guidelines.', 'detailedDescription': 'The purpose of this study is to assess the quality of therapy in patients having come for the first time consultation to the specialized cardiology department of the scientific research centre within the PROFILE registry and to try to correct therapy according to current clinical guidelines paying particular attention to reaching target blood pressure (BP), low-density lipoprotein cholesterol (LDL-C), glycosylated haemoglobin - HbA1c (in patients with diabetes mellitus) levels, improving exercise tolerance and quality of life.\n\nThe first visit (V0) is an inclusion in the study. During this visit, an attempt to correct or start (if it had not been started before) antiplatelet, hypolipidemic, antihypertensive and antianginal therapy will be made.\n\nThe second visit (V1) is planned for each patient three months after the first visit (V0). During the second visit number of patients who reached target levels of BP, LDL-C, frequency of angina attacks will be assessed. If necessary, correction of therapy will also be made.\n\nThe third visit (V2) is planned for each patient one year after the first visit (V0). During the third visit reaching target BP, LDL-C levels, frequency of angina attacks will be assessed. If necessary, therapy correction will be recommended.\n\nThe last visit - telephone contact with patients - is expected in 2 years after the first visit. During that visit it is planned to assess life status, complications and current medical treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with documented IHD having consequentially come for consultation to the specialized cardiology department of the scientific research center from December 31, 2017 to December 31, 2022', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nAll patients with documented IHD having consequentially come for the first time for consultation to the specialized cardiology department of the scientific research center from December 31, 2017 to December 31, 2022.\n\nDocumented IHD:\n\n1. Positive results of the angina questionnaire (typical angina)\n2. Positive exercise electrocardiography or stress echocardiography, plus one of the following criteria:\n\n * ischemia documented by scintigraphy study\n * invasive coronary angiography data (stenosis of at least 75% in at least one main coronary artery)\n * previous coronary revascularization (percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG))\n * previous myocardial infarction\n * patients who had elective PCI or CABG\n\nExclusion Criteria:\n\n* Patients with acute IHD (less than 30 days since the last ischemic event with or without invasive procedures for the treatment of the event)\n* Patients' refuse to follow the study's graphic of doctors' visits"}, 'identificationModule': {'nctId': 'NCT04162561', 'briefTitle': 'TherApy in stabLe Coronary Artery dIsease Patients According to Clinical GuideliNes (ALIGN)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Medical Research Center for Therapy and Preventive Medicine'}, 'officialTitle': 'Trying to Improve Quality of therApy in Patients With stabLe Coronary Artery dIsease According to Current Clinical GuideliNes (ALIGN)', 'orgStudyIdInfo': {'id': 'PROFILE'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Patients with documented IHD', 'type': 'BEHAVIORAL', 'description': "Assessment of patients' quality of life with the use of the Seattle Angina Questionnaire (SAQ), blood pressure levels (using the Korotkoff method, blood pressure is measured 3 times with 1-minute intervals on the hand with the higher blood pressure levels while sitting calm after a 5-minutes rest), laboratory methods (lipids, glycosylated hemoglobin levels), patients' adherence to treatment (original questionnaire), quality of patients' therapy taken at the time of visit, necessity of invasive coronary revascularization procedures (during all visits)."}]}, 'contactsLocationsModule': {'locations': [{'zip': '101990', 'city': 'Moscow', 'country': 'Russia', 'facility': 'National Research Center for Preventive Medicine', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Sergey Martsevich, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Research Center for Preventive Medicine'}, {'name': 'Ekaterina Zharkova, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Research Center for Preventive Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Research Center for Preventive Medicine', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}