Clinical trial NCT04162561: TherApy in stabLe Coronary Artery dIsease Patients According to Clinical GuideliNes (ALIGN)
Official title: Trying to Improve Quality of therApy in Patients With stabLe Coronary Artery dIsease According to Current Clinical GuideliNes (ALIGN)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stable Ischemic Heart Disease
Keywords: quality of therapy
current clinical guidelines
Lead sponsor: National Medical Research Center for Therapy and Preventive Medicine
Sponsor class: OTHER_GOV
First posted: 2019-11-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.

Detailed description: 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.

The 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.

The 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.

The 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.

The 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.

Eligibility criteria: Inclusion Criteria:

All 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.

Documented IHD:

1. Positive results of the angina questionnaire (typical angina)
2. Positive exercise electrocardiography or stress echocardiography, plus one of the following criteria:

   * ischemia documented by scintigraphy study
   * invasive coronary angiography data (stenosis of at least 75% in at least one main coronary artery)
   * previous coronary revascularization (percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG))
   * previous myocardial infarction
   * patients who had elective PCI or CABG

Exclusion Criteria:

* Patients with acute IHD (less than 30 days since the last ischemic event with or without invasive procedures for the treatment of the event)
* Patients' refuse to follow the study's graphic of doctors' visits

Primary outcomes:
measure: Adherence to life-modifying treatment
timeFrame: 1 year
measure: Achievement of the target LDL-C and BP levels
timeFrame: 1 year
Secondary outcomes:
measure: all-cause mortality
timeFrame: 2 years
measure: Myocardial Infarction
timeFrame: 2 years
measure: Stroke
timeFrame: 2 years
measure: Unplanned hospitalization for cardiovascular diseases
timeFrame: 2 years
measure: Myocardial revascularization
timeFrame: 2 years
measure: improvement of the functional class of angina in at least 1-grade level
timeFrame: 1 year
measure: Compliance to life-modifying treatment
timeFrame: 1 year
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: National Research Center for Preventive Medicine
Study officials:
affiliation: National Research Center for Preventive Medicine
name: Sergey Martsevich, PhD
role: STUDY_CHAIR
affiliation: National Research Center for Preventive Medicine
name: Ekaterina Zharkova, MD
role: PRINCIPAL_INVESTIGATOR
References:
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
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
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
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