- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04204330
Federal Cardiomonitoring System. Determination of the Efficiency of a Single-lead ECG Monitor. (FECAS-AFS)
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Mytishchi, Russian Federation, 141005
- Clinic №1, State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
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Mytishchi, Russian Federation, 141005
- Clinic №4, State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
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Belyaninovo Village, Central Str., 41
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Mytishchi, Belyaninovo Village, Central Str., 41, Russian Federation, 141032
- State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
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Boltino Village, Building 91
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Mytishchi, Boltino Village, Building 91, Russian Federation, 141032
- State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
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Microdistrict Of The Village Pirogovskiy, Sovetskaya Str.
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Mytishchi, Microdistrict Of The Village Pirogovskiy, Sovetskaya Str., Russian Federation, 141033
- Clinic №2, State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
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Ostashkovo Village, Kashtanovaya Str., Possession 44.
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Mytishchi, Ostashkovo Village, Kashtanovaya Str., Possession 44., Russian Federation, 141036
- Branch of State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
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Pestovo Village, Berezovaya Alleya Str., 4, Room 15.
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Mytishchi, Pestovo Village, Berezovaya Alleya Str., 4, Room 15., Russian Federation, 141035
- State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
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Povedniki Village, Lane Ovrazhny, Building 4.
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Mytishchi, Povedniki Village, Lane Ovrazhny, Building 4., Russian Federation, 141044
- Branch office of State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
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Troitskoye Village, Sel'skaya Str., Building 32.
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Mytishchi, Troitskoye Village, Sel'skaya Str., Building 32., Russian Federation, 141044
- State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
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Turpansionata Village, Turpansionata KVH, Sorokinskoe Highway
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Mytishchi, Turpansionata Village, Turpansionata KVH, Sorokinskoe Highway, Russian Federation, 141000
- Branch office of State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
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Udino Village, Cvetochnaya Str., 3.
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Mytishchi, Udino Village, Cvetochnaya Str., 3., Russian Federation, 141035
- State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
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Vitenevo Village, 58.
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Mytishchi, Vitenevo Village, 58., Russian Federation, 141035
- State Budgetary Healthcare Institution of Moscow Region "Mytishchi City Clinical Hospital"
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CardioQVARK group
Inclusion criteria:
Exclusion criteria:
Withdrawal criteria: 1. Refusal to participate in the study. |
Registration certificate for the medical device No. РЗН 2019/8124 dated February 15, 2019. Product form: phone case. Way of applying:
Recorded parameters:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total number of AF cases newly diagnosed during the study period.
Time Frame: Through study completion, an average of 1 year
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Total number of AF cases newly diagnosed during the study period.
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Through study completion, an average of 1 year
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Number of patients who, for the first time ever, were assigned to anticoagulation therapy.
Time Frame: Through study completion, an average of 1 year
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Number of patients who, for the first time ever, were assigned to anticoagulation therapy.
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Through study completion, an average of 1 year
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Compliance to anticoagulation therapy for warfarin.
Time Frame: 6 months after administration of anticoagulants
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Assessed using data obtained from pharmacokinetic analysis.
International normalised ratio (INR) - target range from 2 to 3.
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6 months after administration of anticoagulants
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Compliance to anticoagulation therapy for new oral anticoagulants.
Time Frame: 6 months after administration of anticoagulants
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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).
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6 months after administration of anticoagulants
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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
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Evaluated as incremental cost-effectiveness ratio of screening per quality adjusted life year gained, and per stroke avoided.
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Through study completion, an average of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean time to diagnosis.
Time Frame: Through study completion, an average of 1 year
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Mean time to diagnosis.
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Through study completion, an average of 1 year
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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
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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.
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Through study completion, an average of 1 year
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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
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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.
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Through study completion, an average of 1 year
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Incidence of ischemic stroke or transient ischemic attack after enrollment in the study.
Time Frame: Through study completion, an average of 1 year
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Defined as frequency of ischemic stroke or transient ischemic attack in patients with newly diagnosed AF and assigned anticoagulants.
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Through study completion, an average of 1 year
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Incidence of massive hemorrhage after enrollment in the study.
Time Frame: Through study completion, an average of 1 year
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Defined as frequency of massive hemorrhage in patients with newly diagnosed AF and assigned anticoagulants.
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Through study completion, an average of 1 year
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Incidence of hemorrhagic stroke after enrollment in the study.
Time Frame: Through study completion, an average of 1 year
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Defined as frequency of hemorrhagic stroke in patients with newly diagnosed AF and assigned anticoagulants.
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Through study completion, an average of 1 year
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Pharmacogenetic testing by polymorphic markers
Time Frame: 6 months after administration of anticoagulants
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6 months after administration of anticoagulants
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Collaborators and Investigators
Investigators
- Principal Investigator: Philipp Kopylov, Professor, I.M. Sechenov First Moscow State Medical University (Sechenov University)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 081018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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