Federal Cardiomonitoring System. Determination of the Efficiency of a Single-lead ECG Monitor.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: CardioQvark cardiac monitor and software, single-lead ECG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Refusal of further participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 96 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CardioQVARK group<br>Inclusion criteria: Males and females aged 20 to 96 years having one or more of the following risk factors: hypertensive heart disease; history of ischemic stroke or transient ischemic attacks; type 1 and 2 diabetes; class 1-3 obesity; heart failure or decreased tolerance to physical activity due to dyspnea; coronary artery disease (CAD) or chest pain without established CAD diagnosis; peripheral artery atherosclerosis; abnormal heart rhythms (episodes of palpitations, pauses in heartbeat). A patient's consent to participate in the study and the ability to sign an informed consent form. Exclusion criteria: acute coronary syndrome; acute ischemic or hemorrhagic stroke; mental illness; severe concomitant disease with life expectancy less than 2 years. Withdrawal criteria: 1. Refusal to participate in the study. | Device: CardioQvark cardiac monitor and software, single-lead ECG<br>* Registration certificate for the medical device No. РЗН 2019/8124 dated February 15, 2019. Product form: phone case. Way of applying: Download the CardioQVARK mobile application; create a profile. Fill out the questionnaire: age; date of birth; sex; weight; height; blood type; eye color; hair color; occupation; town; alcohol consumption; tobacco use; overeating; insufficient sleep; hypertension; type 2 diabetes; pacemaker; the 10th revision of the International Classification of Diseases (ICD-10) code; medicines. Place index fingers on sensors that are on the case's backside and record 1-lead ECG of up to 3 minutes duration. Recorded parameters: time parameters of the ECG intervals (RR, P, PR, QRS, QT, QTc); abnormal rhythms; heart rate variability; additional function - blood pressure and blood sugar diary. All recorded and calculated parameters are passed to the server.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of AF cases newly diagnosed during the study period. | Total number of AF cases newly diagnosed during the study period. | Through study completion, an average of 1 year | 
| Number of patients who, for the first time ever, were assigned to anticoagulation therapy. | Number of patients who, for the first time ever, were assigned to anticoagulation therapy. | Through study completion, an average of 1 year | 
| Compliance to anticoagulation therapy for warfarin. | Assessed using data obtained from pharmacokinetic analysis. International normalised ratio (INR) - target range from 2 to 3. | 6 months after administration of anticoagulants | 
| Compliance to anticoagulation therapy for new oral 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). | 6 months after administration of anticoagulants | 
| Cost-effectiveness of using the single-lead CardioQVARK ECG device in screening for AF in primary health care. | Evaluated as incremental cost-effectiveness ratio of screening per quality adjusted life year gained, and per stroke avoided. | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean time to diagnosis. | 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 ≥ 1. | 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 | 
| 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. | 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. | Defined as frequency of ischemic stroke or transient ischemic attack in patients with newly diagnosed AF and assigned anticoagulants. | Through study completion, an average of 1 year | 
| Incidence of massive hemorrhage after enrollment in the study. | Defined as frequency of massive hemorrhage in patients with newly diagnosed AF and assigned anticoagulants. | Through study completion, an average of 1 year | 
| Incidence of hemorrhagic stroke after enrollment in the study. | Defined as frequency of hemorrhagic stroke in patients with newly diagnosed AF and assigned anticoagulants. | Through study completion, an average of 1 year | 
| Pharmacogenetic testing by polymorphic markers | For warfarin - CYP2C9 (CYP2C9 * 2, CYP2C9 * 3), VKORC1 (1 marker), CYP4F2 (1 marker), GGCX (1 marker). For new oral anticoagulants - rs2244613 of the gene CES1, rs1045642 (C3435T), rs1128503 (C1236T), rs2032582 (G2677T / А) of the gene ABCB1, rs2231142 (С421А, Q141K) of the gene ABCG2, rs776746 (A6986G * 399 CYP3 CYP3) CYP3A4. | 6 months after administration of anticoagulants | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, electronic health, mobile health