Non-contact ECG Sensor System for COVID19 | NCT04341506

Studies
Non-contact ECG Sensor System for COVID19

NCT04341506

Sponsor

Northwestern Medicine

Status

Unknown status

Last Update Posted

Sep 9, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

COVID-19

Interventions

Non-contact ECG

Countries

United States

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

Sep 2020

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

Sep 8, 2020Actual

Primary Completion Date

Jul 15, 2021Estimated

Completion Date

Dec 15, 2021Estimated

First Submitted Date

Apr 7, 2020

First Submission Date that Met QC Criteria

Apr 7, 2020

First Posted Date

Apr 10, 2020Actual

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

Sep 8, 2020

Last Update Posted Date

Sep 9, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is two-fold. First we would like to confirm that non-contact ECG provides equivalency to current contact methods of obtaining ECG data. Second we would like to investigate whether non-contact ECG can detect ECG changes prior to the onset symptoms from COVID19.

Detailed Description

Not provided

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participant ECG		The study has one arm, I.e., we will collect daily ECGs in 100 participants and track their ECG over three months. We will then compare ECGs pre and post COVID-19 diagnosis in any participant diagnosed with COVID-19 to assess for any early ECG changes that may aid with diagnosing.	Device: Non-contact ECG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-contact ECG	Device	A non-contact ECG will be used to detect a patient cardiac electrical activity.	Participant ECG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ECG changes associated with COVID-19	Assess different ECG changes in participants diagnosed with COVID-10	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any employee of Lake Forrest Memorial Hospital presenting to work
Age greater than 18 years-old

Exclusion Criteria:

Age less than 18 years-old
Non-employee

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

100 employees of Lake Forrest Memorial Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andrew Gostine, MD	Contact	(312) 695-0061		andrew.gostine@nm.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern Medicine	Recruiting	Chicago	Illinois	60610	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D001145	Arrhythmias, Cardiac

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided