Trying to Improve Quality of therApy in Patients With stabLe Coronary Artery dIsease According to Current Clinical GuideliNes (ALIGN)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stable Ischemic Heart Disease
- Sponsor
- National Research Center for Preventive Medicine
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Achievement of the target LDL-C and BP levels
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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,
- •Documented IHD:
- •Positive results of the angina questionnaire (typical angina)
- •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
Outcomes
Primary Outcomes
Achievement of the target LDL-C and BP levels
Time Frame: 1 year
Target LDL-C levels - less than 1.8 mmol/l, target BP levels - less than 140/90 mmHg
Adherence to life-modifying treatment
Time Frame: 1 year
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.
Secondary Outcomes
- Unplanned hospitalization for cardiovascular diseases(2 years)
- Myocardial revascularization(2 years)
- all-cause mortality(2 years)
- improvement of the functional class of angina in at least 1-grade level(1 year)
- Myocardial Infarction(2 years)
- Compliance to life-modifying treatment(1 year)
- Stroke(2 years)