NCT04204330

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5,000 (actual)
• Sponsor: I.M. Sechenov First Moscow State Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 96 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	CardioQvark cardiac monitor and software, single-lead ECG	Registration certificate for the medical device No. РЗН 2019/8124 dated February 15, 2019. Product form: phone case. Way of applying: 1. Download the CardioQVARK mobile application; create a profile. 2. 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. 3. 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.

Timeline

• Start date: 2019-03-04
• Primary completion: 2024-10-03
• Completion: 2024-10-03
• First posted: 2019-12-18
• Last updated: 2024-10-08

Locations

12 sites across 1 country: Russia