NCT04341506

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 10, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

September 8, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

10 months

First QC Date

April 7, 2020

Last Update Submit

September 8, 2020

Conditions

COVID-19

Keywords

COVID-19ECGArrhythmia

Outcome Measures

Primary Outcomes (1)

  • ECG changes associated with COVID-19

    Assess different ECG changes in participants diagnosed with COVID-10

    3 months

Study Arms (1)

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

Non-contact ECGDEVICE

A non-contact ECG will be used to detect a patient cardiac electrical activity.

Participant ECG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

100 employees of Lake Forrest Memorial Hospital

You may qualify if:

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

You may not qualify if:

  • Age less than 18 years-old
  • Non-employee

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Medicine

Chicago, Illinois, 60610, United States

RECRUITING

MeSH Terms

Conditions

COVID-19Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Andrew Gostine, MD

CONTACT

(312) 695-0061andrew.gostine@nm.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 7, 2020

First Posted

April 10, 2020

Study Start

September 8, 2020

Primary Completion

July 15, 2021

Study Completion

December 15, 2021

Last Updated

September 9, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)