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

NCT04204330 | Completed

• 1 other identifier: 081018
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 12

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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; electronic health; mobile health

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• 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.

  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

Study Arms (1)

CardioQVARK group

EXPERIMENTAL

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.

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

Interventions

CardioQvark cardiac monitor and software, single-lead ECG 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.

CardioQVARK group

Eligibility Criteria

• Age: 18 Years - 96 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Refusal of further participation in the study

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (12)

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

Mytishchi, Belyaninovo Village, Central Str., 41, 141032, Russia

Location

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

Mytishchi, Boltino Village, Building 91, 141032, Russia

Location

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

Mytishchi, Microdistrict of the Village Pirogovskiy, Sovetskaya Str., 141033, Russia

Location

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

Mytishchi, Ostashkovo Village, Kashtanovaya Str., Possession 44., 141036, Russia

Location

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

Mytishchi, Pestovo Village, Berezovaya Alleya Str., 4, Room 15., 141035, Russia

Location

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

Mytishchi, Povedniki Village, Lane Ovrazhny, Building 4., 141044, Russia

Location

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

Mytishchi, Troitskoye Village, Sel'skaya Str., Building 32., 141044, Russia

Location

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

Mytishchi, Turpansionata Village, Turpansionata KVH, Sorokinskoe Highway, 141000, Russia

Location

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

Mytishchi, Udino Village, Cvetochnaya Str., 3., 141035, Russia

Location

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

Mytishchi, Vitenevo Village, 58., 141035, Russia

Location

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

Mytishchi, 141005, Russia

Location

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

Mytishchi, 141005, Russia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Philipp Kopylov, Professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2019
• First Posted: December 18, 2019
• Study Start: March 4, 2019
• Primary Completion: October 3, 2024
• Study Completion: October 3, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (12)