Atrial FibrillationFECAS-AFSNCT04204330
Federal Cardiomonitoring System. Determination of the Efficiency of a Single-lead ECG Monitor.
A study testing CardioQvark cardiac monitor and software, single-lead ECG in people with Atrial Fibrillation, run by I.M. Sechenov First Moscow State Medical University at 12 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 96 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- CardioQvark cardiac monitor and software, single-lead ECG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 12 sitesRussia
- Study dates
- 4 Mar 2019to 3 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 96 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- Refusal of further participation in the study
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Russia12 sites
State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
Mytishchi, Belyaninovo Village, Central Str., 41, 141032
State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
Mytishchi, Boltino Village, Building 91, 141032
Clinic №2, State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
Mytishchi, Microdistrict of the Village Pirogovskiy, Sovetskaya Str., 141033
Branch of State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
Mytishchi, Ostashkovo Village, Kashtanovaya Str., Possession 44., 141036
State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
Mytishchi, Pestovo Village, Berezovaya Alleya Str., 4, Room 15., 141035
Branch office of State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
Mytishchi, Povedniki Village, Lane Ovrazhny, Building 4., 141044
State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
Mytishchi, Troitskoye Village, Sel'skaya Str., Building 32., 141044
Branch office of State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
Mytishchi, Turpansionata Village, Turpansionata KVH, Sorokinskoe Highway, 141000
State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
Mytishchi, Udino Village, Cvetochnaya Str., 3., 141035
State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
Mytishchi, Vitenevo Village, 58., 141035
Clinic №1, State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
Mytishchi, 141005
Clinic №4, State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
Mytishchi, 141005
About this study
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.
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.
Read the 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:
- 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.
- 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.
- Three independent cardiology experts receive ECG records and verify the performance of the algorithm. They decode and annotate ECG reports (PDF).
- 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.
- 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.
- Anticoagulation therapy is revised or induced for all patients with diagnosed AF.
- 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).
- Estimating cost-effectiveness of using the single-lead CardioQVARK ECG device in screening for AF in primary health care.
- Statistical processing of data and endpoints determination.
- Conditions
- Atrial Fibrillation
- Being tested
- CardioQvark cardiac monitor and software, single-lead ECG
- Keywords
- atrial fibrillation, electronic health, mobile health
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioQvark cardiac monitor and software, single-lead ECGDevice
Registration certificate for the medical device No. РЗН 2019/8124 dated February 15, 2019.
Product form: phone case.
Way of applying:
- Download the CardioQVARK mobile application; create a profile.
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CardioQvark cardiac monitor and software, single-lead ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of AF cases newly diagnosed during the study period.
Total number of AF cases newly diagnosed during the study period.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (7)
Mean time to diagnosis.
Mean time to diagnosis.
Measured: 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.
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.
Measured: 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.
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.
Measured: Through study completion, an average of 1 year
Incidence of ischemic stroke or transient ischemic attack after enrollment in the study.
Defined as frequency of ischemic stroke or transient ischemic attack in patients with newly diagnosed AF and assigned anticoagulants.
Measured: Through study completion, an average of 1 year
Incidence of massive hemorrhage after enrollment in the study.
Defined as frequency of massive hemorrhage in patients with newly diagnosed AF and assigned anticoagulants.
Measured: Through study completion, an average of 1 year
Incidence of hemorrhagic stroke after enrollment in the study.
Defined as frequency of hemorrhagic stroke in patients with newly diagnosed AF and assigned anticoagulants.
Measured: Through study completion, an average of 1 year
Pharmacogenetic testing by polymorphic markers
- For warfarin - CYP2C9 (CYP2C9 * 2, CYP2C9 * 3), VKORC1 (1 marker), CYP4F2 (1 marker), GGCX (1 marker).
- For new oral anticoagulants - rs2244613 of the gene CES1, rs1045642 (C3435T), rs1128503 (C1236T), rs2032582 (G2677T / А) of the gene ABCB1, rs2231142 (С421А, Q141K) of the gene ABCG2, rs776746 (A6986G * 399 CYP3 CYP3) CYP3A4.
Measured: 6 months after administration of anticoagulants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start4 Mar 2019
- Primary completion3 Oct 2024
- Study completion3 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philipp Kopylov, Professor, Principal investigator, I.M. Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204330
- Sponsor's protocol ID
- 081018
- Acronym
- FECAS-AFS
- Status last verified
- Oct 2024
- First submitted
- 7 Dec 2019
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research sponsor is Sechenov University. Data disclosure is not permitted by the local ethics committee. For more information about the study, you need to contact the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04204330
- Acronym / sponsor ID
- FECAS-AFS / 081018
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, electronic health, mobile health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 3 Oct 2024 (actual)
- Study completion
- 3 Oct 2024 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- Three independent cardiology experts receive ECG records and verify the performance of the algorithm. They decode and annotate ECG reports (PDF).
- 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.
- 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.
- Anticoagulation therapy is revised or induced for all patients with diagnosed AF.
- 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).
- Estimating cost-effectiveness of using the single-lead CardioQVARK ECG device in screening for AF in primary health care.
- Statistical processing of data and endpoints determination.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CardioQVARK group | Experimental | Device: CardioQvark cardiac monitor and software, single-lead ECGInclusion 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. |
Who may qualify
- Ages
- 18 to 96 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (1 listed)
- Refusal of further participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardioQvark cardiac monitor and software, single-lead ECGRegistration 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. | Device | CardioQVARK group |
Primary outcome
Total number of AF cases newly diagnosed during the study period.
Time frame: Through study completion, an average of 1 year
Total number of AF cases newly diagnosed during the study period.
Number of patients who, for the first time ever, were assigned to anticoagulation therapy.
Time frame: Through study completion, an average of 1 year
Number of patients who, for the first time ever, were assigned to anticoagulation therapy.
Compliance to anticoagulation therapy for warfarin.
Time frame: 6 months after administration of anticoagulants
Assessed using data obtained from pharmacokinetic analysis. International normalised ratio (INR) - target range from 2 to 3.
Compliance to anticoagulation therapy for new oral anticoagulants.
Time frame: 6 months after administration of 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).
Cost-effectiveness of using the single-lead CardioQVARK ECG device in screening for AF in primary health care.
Time frame: Through study completion, an average of 1 year
Evaluated as incremental cost-effectiveness ratio of screening per quality adjusted life year gained, and per stroke avoided.
7 secondary outcomes
Mean time to diagnosis.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 1 year
Incidence of ischemic stroke or transient ischemic attack after enrollment in the study.
Time frame: Through study completion, an average of 1 year
Incidence of massive hemorrhage after enrollment in the study.
Time frame: Through study completion, an average of 1 year
Incidence of hemorrhagic stroke after enrollment in the study.
Time frame: Through study completion, an average of 1 year
Pharmacogenetic testing by polymorphic markers
Time frame: 6 months after administration of anticoagulants
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No. The research sponsor is Sechenov University. Data disclosure is not permitted by the local ethics committee. For more information about the study, you need to contact the principal investigator.
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Kopylov, Professor principal investigator
I.M. Sechenov First Moscow State Medical University (Sechenov University)
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CardioQvark cardiac monitor and software, single-lead ECG in people with Atrial Fibrillation, run by I.M. Sechenov First Moscow State Medical University at 12 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of AF cases newly diagnosed during the study period. (time frame: Through study completion, an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.