Clinical trial NCT04204330: Federal Cardiomonitoring System. Determination of the Efficiency of a Single-lead ECG Monitor.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
electronic health
mobile health
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 96
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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)

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

Primary outcomes:
measure: Total number of AF cases newly diagnosed during the study period.
timeFrame: Through study completion, an average of 1 year
measure: Number of patients who, for the first time ever, were assigned to anticoagulation therapy.
timeFrame: Through study completion, an average of 1 year
measure: Compliance to anticoagulation therapy for warfarin.
timeFrame: 6 months after administration of anticoagulants
measure: Compliance to anticoagulation therapy for new oral anticoagulants.
timeFrame: 6 months after administration of anticoagulants
measure: Cost-effectiveness of using the single-lead CardioQVARK ECG device in screening for AF in primary health care.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Mean time to diagnosis.
timeFrame: Through study completion, an average of 1 year
measure: 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.
timeFrame: Through study completion, an average of 1 year
measure: 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.
timeFrame: Through study completion, an average of 1 year
measure: Incidence of ischemic stroke or transient ischemic attack after enrollment in the study.
timeFrame: Through study completion, an average of 1 year
measure: Incidence of massive hemorrhage after enrollment in the study.
timeFrame: Through study completion, an average of 1 year
measure: Incidence of hemorrhagic stroke after enrollment in the study.
timeFrame: Through study completion, an average of 1 year
measure: Pharmacogenetic testing by polymorphic markers
timeFrame: 6 months after administration of anticoagulants
Other outcomes:
Locations:
city: Mytishchi
country: Russian Federation
facility: State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
state: Belyaninovo village, Central str., 41
city: Mytishchi
country: Russian Federation
facility: State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
state: Boltino village, building 91
city: Mytishchi
country: Russian Federation
facility: Clinic №2, State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
state: microdistrict of the village Pirogovskiy, Sovetskaya str.
city: Mytishchi
country: Russian Federation
facility: Branch of State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
state: Ostashkovo village, Kashtanovaya str., possession 44.
city: Mytishchi
country: Russian Federation
facility: State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
state: Pestovo village, Berezovaya alleya str., 4, room 15.
city: Mytishchi
country: Russian Federation
facility: Branch office of State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
state: Povedniki village, lane Ovrazhny, building 4.
city: Mytishchi
country: Russian Federation
facility: State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
state: Troitskoye village, Sel'skaya str., building 32.
city: Mytishchi
country: Russian Federation
facility: Branch office of State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
state: Turpansionata village, Turpansionata KVH, Sorokinskoe highway
city: Mytishchi
country: Russian Federation
facility: State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
state: Udino village, Cvetochnaya str., 3.
city: Mytishchi
country: Russian Federation
facility: State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
state: Vitenevo village, 58.
city: Mytishchi
country: Russian Federation
facility: Clinic №1, State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
city: Mytishchi
country: Russian Federation
facility: Clinic №4, State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
Study officials:
affiliation: I.M. Sechenov First Moscow State Medical University (Sechenov University)
name: Philipp Kopylov, Professor
role: PRINCIPAL_INVESTIGATOR
References: