Clinical Register Studying the therApeutic Patient Population With Multifocal Atherosclerosis in the Russian Federation and Eurasian Countries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,059
- 试验地点
- 1
- 主要终点
- Occurrence of a cardiovascular event (stroke, ACS, amputation, hospitalizations (related or not to cardiovascular pathology), the number of emergency calls)
研究概览
简要总结
Аn international, multicenter, non-interventional real-life clinical practice Register studying the Actual therapeutic patient population with Multifocal Atherosclerosis in the Russian Federation and Eurasian countries
详细描述
Information on demographics, comorbidities, methods for diagnosing multifocal atherosclerosis (MFA), prescribed therapy, and outcomes will be identified via medical records analysis. Results of arterial bed ultrasound examination (US), results of ankle-brachial index (ABI) measurements, along with clinical and anamnestic data on target organ damage in the MFA-affected areas will be used as the main source verifying the presence MFA.
The follow-up period for each patient will span from the date of inclusion and over the next year with an additional 6 and 12 months of follow-up.
Patients eligible for entry in the Register must be included and their details must be documented. The procedure for obtaining informed consent for the examination and collection of data must comply with the requirements of local legislation. Patients will be required to sign an informed consent document if required.
Standardized electronic CRFs will be used in all research centers. The electronic data collection (EDC) system must be validated in accordance with current standards and legal requirements. Researchers will log into this system using individually assigned usernames and passwords. Data can only be entered and corrected by the researcher or other authorized personnel of the research center.
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
- •Men or women aged 18 and older at the time of data registration; Presence of 2 or more of the following factors
- •Coronary arteries atherosclerosis (atherosclerosis revealed by means of coronary angiography and/or a history of type I myocardial infarction and/or elective PCI and/or CABG and/or angina pectoris with ischemia according to stress test results, history of CHD);
- •Lower extremity arteries atherosclerosis (atherosclerotic plaques revealed by ultrasound, and/or ABI <0.9, and/or a history of revascularization, and/or a history of amputation associated due to chronic lower extremities arterial insufficiency);
- •Atherosclerosis of brachiocephalic arteries or renal arteries (presence of atherosclerotic plaques according to US data and/or history of revascularization and/or history of atherothrombotic stroke or TIA in the absence of known AF);
- •Atherosclerosis of renal arteries or abdominal aorta (presence of atherosclerotic plaques according to US data and/or history of revascularization).
- •Presence of one or more of the following atherosclerotic risk factors:
- •Anamnestic data on dyslipidemia with LDL cholesterol levels above 4.9 mmol/L or total cholesterol levels above 8.0 mmol/L;
- •Presence of confirmed familial hypercholesterolemia;
- •Current smoker status or history of smoking;
- •Overweight (BMI≥ 25 kg/m2);
- •Presence of arterial hypertension;
- •Presence of established type 2 diabetes mellitus;
- •Presence of an established diagnosis of prediabetes;
- •Presence of CKD stage 3a and higher (GFR <60 ml / min / 1.73 m2).
排除标准
- •Life expectancy less than 1 year;
- •Patient refusal to participate in the Register
结局指标
主要结局
Occurrence of a cardiovascular event (stroke, ACS, amputation, hospitalizations (related or not to cardiovascular pathology), the number of emergency calls)
时间窗: after 12 months
To assess the occurrence of cardiovascular events in 6 and 12 months in a cohort of patients with MFA: brain hemorrhage, acute coronary syndrome, amputation, admission to hospital (related or not related to a cardiovascular disease), number of emergency calls
次要结局
- All-cause mortality(after 12 months)
- The frequency of any bleeding episodes (life-threatening, bothersome, or of unknown severity)(after 12 months)
- Prevalence of risk factors in the population(after 12 months)
- Change of 3 point major adverse cardiovascular events parameter (Cardiovascular death, Nonfatal stroke, Non-fatal myocardial infarction)(after 12 months)
- Change of GFR according to Chronic Kidney Disease Epidemiology Collaboration(after 12 months)