Federal Cardiomonitoring System. Determination of the Efficiency of a Single-lead ECG Monitor. (FECAS-AFS)

I.M. Sechenov First Moscow State Medical University

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: CardioQvark cardiac monitor and software, single-lead ECG

Study type: Interventional

Funder types: Other

Identifiers

NCT04204330

081018

Details and patient eligibility

About

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.

Full description

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:

1. 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.
2. 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.
3. Three independent cardiology experts receive ECG records and verify the performance of the algorithm. They decode and annotate ECG reports (PDF).
4. 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.
5. 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.
6. Anticoagulation therapy is revised or induced for all patients with diagnosed AF.
7. 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).
8. Estimating cost-effectiveness of using the single-lead CardioQVARK ECG device in screening for AF in primary health care.
9. Statistical processing of data and endpoints determination.

Enrollment: 5,000 patients

Sex: All

Ages: 18 to 96 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5,000 participants in 1 patient group

CardioQVARK group

Experimental group

Description:

Inclusion criteria: 1. 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). 2. A patient's consent to participate in the study and the ability to sign an informed consent form. Exclusion criteria: 1. acute coronary syndrome; 2. acute ischemic or hemorrhagic stroke; 3. mental illness; 4. severe concomitant disease with life expectancy less than 2 years. Withdrawal criteria: 1. Refusal to participate in the study.

Treatment:

Device: CardioQvark cardiac monitor and software, single-lead ECG