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

NCT ID: NCT04204330

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-04
• Study Completion Date: 2024-10-03

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CardioQVARK group

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.

Group Type: EXPERIMENTAL

CardioQvark cardiac monitor and software, single-lead ECG

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 96 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philipp Kopylov, Professor

Role: PRINCIPAL_INVESTIGATOR

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Locations

State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"

Mytishchi, Belyaninovo Village, Central Str., 41, Russia

State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"

Mytishchi, Boltino Village, Building 91, Russia

Clinic №2, State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"

Mytishchi, Microdistrict of the Village Pirogovskiy, Sovetskaya Str., Russia

Branch of State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"

Mytishchi, Ostashkovo Village, Kashtanovaya Str., Possession 44., Russia

State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"

Mytishchi, Pestovo Village, Berezovaya Alleya Str., 4, Room 15., Russia

Branch office of State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"

Mytishchi, Povedniki Village, Lane Ovrazhny, Building 4., Russia

State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"

Mytishchi, Troitskoye Village, Sel'skaya Str., Building 32., Russia

Branch office of State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"

Mytishchi, Turpansionata Village, Turpansionata KVH, Sorokinskoe Highway, Russia

State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"

Mytishchi, Udino Village, Cvetochnaya Str., 3., Russia

State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"

Mytishchi, Vitenevo Village, 58., Russia

Clinic №1, State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"

Mytishchi, , Russia

Clinic №4, State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"

Mytishchi, , Russia

Countries

Russia

Other Identifiers

081018

Identifier Type: -

Identifier Source: org_study_id