Federal Cardiomonitoring System. Determination of the Efficiency of a Single-lead ECG Recorded with CardioQVARK Cardiac Monitor in Order to Detect Atrial Fibrillation in Primary Health Centers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,000
- 试验地点
- 15
- 主要终点
- Number of patients who, for the first time ever, were assigned to anticoagulation therapy.
研究概览
简要总结
This interventional prospective multicenter nonrandomized clinical and epidemiological study is the first Russian study aimed at evaluating the effectiveness of a single-lead electrocardiography device (CardioQVARK) in screening for atrial fibrillation in primary health care.
详细描述
This is an interventional, prospective, multicenter, nonrandomized clinical and epidemiological study. We are planning to enroll 5,000 patients.
Three outpatient departments, 3 affiliates of a city clinical hospital and 6 rural health posts in Moscow region are equipped with 25 CardioQVARK electrocardiography (ECG) devises.
The study implies 9 stages:
- Patient signs informed consent and consent to the processing of personal data than fills out a questionnaire in a mobile application (https://itunes.apple.com/ru/app/cardioqvark/id1320898122) and registers a 3-minute ECG with a single-lead CardioQVARK ECG device. If an episode of atrial fibrillation (AF) is not detected during a reception, but a patient describes symptoms of AF, we hand out the devices to such patients to take home with them.
- All records that are registered at outpatient departments, affiliates, rural health posts and at home are sent to a server of "CardioQVARK" (Limited Liability Company). For data processing, an AF detecting algorithm is applied. If AF is detected, an ECG report is generated in PDF format.
- Three independent cardiology experts receive ECG records and verify the performance of the algorithm. They decode and annotate ECG reports (PDF).
- If the expert confirms that the algorithm detected an AF episode, the ECG report (PDF) is sent to an arrhythmologist for diagnosis. After that, the ECG record with confirmed diagnosis is passed to a physician at a health-care facility.
- When the physician receives the report, he calls the patient to verify the diagnosis in a face-to-face consultation. That can be done by routine ECG, 24-, 48- or 72-hour ECG monitoring.
- Anticoagulation therapy is revised or induced for all patients with diagnosed AF.
- Six months after the enrollment, the patient is called for another face-to-face consultation with further peripheral venous blood sampling to assess anticoagulation therapy in terms of pharmacokinetics (assess compliance) and pharmacogenetics (assess the influence of genetic factors on anticoagulant effect of warfarin and new oral anticoagulants).
- Estimating cost-effectiveness of using the single-lead CardioQVARK ECG device in screening for AF in primary health care.
- Statistical processing of data and endpoints determination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 96 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 to 96 years who have one or more of the following risk factors:
- •hypertonic disease
- •history of ischemic stroke or transient ischemic attacks
- •type 1 and type 2 diabetes
- •1-3 degrees obesity
- •heart failure or the presence of a clinic to reduce exercise tolerance associated with shortness of breath
- •coronary heart disease or the presence of symptoms of chest pain, in the absence of an established diagnosis of coronary heart disease
- •the presence of peripheral arterial atherosclerosis
- •the presence of a clinic of interruptions in the work of the heart (bouts of rapid, irregular heartbeats, pauses in work of heart)
- •Non-inclusion criteria:
- •Acute coronary syndrome
- •Acute ischemic or hemorrhagic stroke
- •Acute psychosis
- •The presence of severe concomitant diseases with an expected life expectancy of less than 2 years
排除标准
- •Refusal of further participation in the study
结局指标
主要结局
Number of patients who, for the first time ever, were assigned to anticoagulation therapy.
时间窗: Through study completion, an average of 1 year
Number of patients who, for the first time ever, were assigned to anticoagulation therapy.
Total number of AF cases newly diagnosed during the study period.
时间窗: Through study completion, an average of 1 year
Total number of AF cases newly diagnosed during the study period.
Compliance to anticoagulation therapy for warfarin.
时间窗: 6 months after administration of anticoagulants
Assessed using data obtained from pharmacokinetic analysis. International normalised ratio (INR) - target range from 2 to 3.
Cost-effectiveness of using the single-lead CardioQVARK ECG device in screening for AF in primary health care.
时间窗: Through study completion, an average of 1 year
Evaluated as incremental cost-effectiveness ratio of screening per quality adjusted life year gained, and per stroke avoided.
Compliance to anticoagulation therapy for new oral anticoagulants.
时间窗: 6 months after administration of anticoagulants
Assessed using data obtained from pharmacokinetic analysis. Quantitative determination of the concentration of drugs in the blood (blood sampling three hours after taking the drug).
次要结局
- Number of patients with a CHA₂DS₂-VASc score (the CHA2DS2-VASc Score is the most commonly utilized method to predict thromboembolic risk in atrial fibrillation) of ≥ 1.(Through study completion, an average of 1 year)
- Mean time to diagnosis.(Through study completion, an average of 1 year)
- Number of patients with a CHA₂DS₂-VASc score (the CHA2DS2-VASc Score is the most commonly utilized method to predict thromboembolic risk in atrial fibrillation) of ≥ 2.(Through study completion, an average of 1 year)
- Incidence of ischemic stroke or transient ischemic attack after enrollment in the study.(Through study completion, an average of 1 year)
- Incidence of massive hemorrhage after enrollment in the study.(Through study completion, an average of 1 year)
- Incidence of hemorrhagic stroke after enrollment in the study.(Through study completion, an average of 1 year)
- Pharmacogenetic testing by polymorphic markers(6 months after administration of anticoagulants)