QT-Logs : Artificial Intelligence for QT Interval Analysis of ECG From Smartwatches in Patient Receiving Treatment for Covid-19

NCT ID: NCT04371744

Last Updated: 2020-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-17

Study Completion Date

2020-06-05

Brief Summary

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This observational pilot prospective study will evaluate a new method for remote monitoring of corrected QT measurement using an artificial intelligence (AI)-based solution and ECG data collected via smartwatches (AI-QTc), in patients ambulatory treated with the HC-AZ combination, at the early stage of COVID-19 infection, at a tertiary hospital center. Daily ECGs will be performed via the smartwatches. AI-QTc will be compared to standard manual QTc reviewed by cardiologist. Correlation and agreement between measures will be assessed.

Detailed Description

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Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patient over 18 years old
* SARS-COV-2 confirmed infection by positive nasopharyngual PCR
* Prescription of association hydroxychloroquine and azythromycine for COVI-19 therapy
* Patient's smartphone able to download the smartwatches application

Exclusion Criteria

* Presence of a pacemaker
* Pregnant or breastfeeding females
* Refusal to participate
* Incapacity
* Adult under legal protection (trusteeship, guardianship)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Assistance Publique Hôpitaux de Marseille

Marseille, , France

Site Status

Countries

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France

References

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Maille B, Wilkin M, Million M, Resseguier N, Franceschi F, Koutbi-Franceschi L, Hourdain J, Martinez E, Zabern M, Gardella C, Tissot-Dupont H, Singh JP, Deharo JC, Fiorina L. Smartwatch Electrocardiogram and Artificial Intelligence for Assessing Cardiac-Rhythm Safety of Drug Therapy in the COVID-19 Pandemic. The QT-logs study. Int J Cardiol. 2021 May 15;331:333-339. doi: 10.1016/j.ijcard.2021.01.002. Epub 2021 Jan 29.

Reference Type DERIVED
PMID: 33524462 (View on PubMed)

Other Identifiers

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CIL 2020-52

Identifier Type: -

Identifier Source: org_study_id

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