NCT04162561

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: National Research Center for Preventive Medicine · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stable Ischemic Heart Disease

Interventions

Type	Name	Description
BEHAVIORAL	Patients with documented IHD	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).

Timeline

• Start date: 2017-12-31
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2019-11-14
• Last updated: 2023-03-15

Locations

1 site across 1 country: Russia