Evaluation of Electrocardiography Performed With Mobile E... | NCT05206825

Studies
Evaluation of Electrocardiography Performed With Mobile ECG Devices in Cardiac Patients and Healthy Volunteers

NCT05206825

Sponsor

Medical University of Lodz

Status

Unknown status

Last Update Posted

Jul 19, 2022Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Cardiac Arrhythmia

Interventions

Not provided

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2022Actual

Primary Completion Date

Jun 2023Estimated

Completion Date

Dec 1, 2023Estimated

First Submitted Date

Jan 12, 2022

First Submission Date that Met QC Criteria

Jan 12, 2022

First Posted Date

Jan 25, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2022

Last Update Posted Date

Jul 19, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Electrocardiography is one of most basic laboratory tests in cardiology. Novel mobile ECG are becoming popular. The investigators aim to compare typical electrocardiographic measurements obtained with mobile ECG devices (Alivecor Kardia and Alivecor Cardia 6L) and 12-leads standard ECG (gold standard). The recordings will be compared by cardiologist paying special attention to heart rhythm disturbances, components of ECG curve and quality of recording.

Detailed Description

ECG evaluation will include: rhythm description, measurements of mean RR, PR, QRS, QT, QTc and ST-T description. Additionally inter/intraventricular conduction abnormalities are to be determined from 12-leads ECG and approximate from mobile ECG recordings.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ECG Tracing Quality	Evaluation of quality of ECG tracings obtained with different electrocardiographs	Once: Day 0-3 after entry to the study.
Cardiac Rhythm Determination	Defining a rhythm of the patient based on recorder tracings.	Once: Day 0-3 after entry to the study.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with indication for electrocardiography
Informed consent to participate in the study
The possibility of self-registration of a mobile ECG (no physical and mental restrictions)

Exclusion Criteria:

Not willing or incapable to give written informed consent.
Lack of willingness to cooperate

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with cardiac diseases,hospitalized in Department of Electrocardiology Medical University of Lodz as well as healthy volunteers will be enrolled to the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Electrocardiology Medical University of Lodz	Recruiting	Lodz		93-216	Poland

Condition Browse Module

MeSH Terms

ID	Term
D001145	Arrhythmias, Cardiac

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided