TherApy in stabLe Coronary Artery dIsease Patients According to Clinical GuideliNes (ALIGN)

Trying to Improve Quality of therApy in Patients With stabLe Coronary Artery dIsease According to Current Clinical GuideliNes (ALIGN)

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.

Study Overview

• Status: Completed
• Conditions: Stable Ischemic Heart Disease
• Intervention / Treatment: Behavioral: Patients with documented IHD

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.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 101990
    • National Research Center for Preventive Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to life-modifying treatment	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. The 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.	1 year
Achievement of the target LDL-C and BP levels	Target LDL-C levels - less than 1.8 mmol/l, target BP levels - less than 140/90 mmHg	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all-cause mortality		2 years
Myocardial Infarction	description - the total number of events	2 years
Stroke	description - the total number of events	2 years
Unplanned hospitalization for cardiovascular diseases	description - the total number of events	2 years
Myocardial revascularization	description - the total number of events	2 years
improvement of the functional class of angina in at least 1-grade level	Assessment of the functional class of angina will be made according to the Canadian Cardiovascular Society grading of angina pectoris	1 year
Compliance to life-modifying treatment	Necessity of the use of the following drugs will be investigated for each patient: antiplatelets, anticoagulants, hypolipidemic drugs, beta-blockers, ACE-inhibitors/ARBs. Later, 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%). In the end, the mean adherence to therapy in the investigated group will be calculated.	1 year

Collaborators and Investigators

• Sponsor: National Research Center for Preventive Medicine
• Investigators: Study Chair: Sergey Martsevich, PhD, National Research Center for Preventive Medicine; Principal Investigator: Ekaterina Zharkova, MD, National Research Center for Preventive Medicine

Publications and helpful links

General Publications

• 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
• 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
• 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
• 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

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2017
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: November 11, 2019
• First Submitted That Met QC Criteria: November 11, 2019
• First Posted (Actual): November 14, 2019

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 12, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: quality of therapy; current clinical guidelines
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: PROFILE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No