Trying to Improve Quality of therApy in Patients With stabLe Coronary Artery dIsease According to Current Clinical GuideliNes (ALIGN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Achievement of the target LDL-C and BP levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Achievement of the target LDL-C and BP levels
时间窗: 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
时间窗: 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.
次要结局
- 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)