QT-Logs : Artificial Intelligence for QT Interval Analysis of ECG From Smartwatches in Patient Receiving Treatment for Covid-19
QT-Logs
QT-Logs : a Clinical Study to Monitor Cardiac Safety, With Artificial Intelligence for QT Interval Analysis of ECG Data From Smartwatches, in Patients Receiving Hydroxychloroquine Treatment for COVID-19
1 other identifier
observational
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 17, 2020
CompletedFirst Submitted
Initial submission to the registry
April 30, 2020
CompletedFirst Posted
Study publicly available on registry
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2020
CompletedJune 9, 2020
June 1, 2020
2 months
April 30, 2020
June 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Corrected QT (QTc) interval measurement
Measurement of QTc using an artificial intelligence (AI)-based solution and ECG data collected via smartwatches, compare to standard 12 leads ECG reviewed by cardiologist
10 days
Eligibility Criteria
100 consecutives patients ambulatory treated with the Hydroxychloroquine and Azythromycine combination, at the early stage of COVID-19 infection for 10 days, at the university hospital of La Timone, in Marseille
You may qualify if:
- 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
You may not qualify if:
- Presence of a pacemaker
- Pregnant or breastfeeding females
- Refusal to participate
- Incapacity
- Adult under legal protection (trusteeship, guardianship)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique Hôpitaux de Marseille
Marseille, 13005, France
Related Publications (1)
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.
PMID: 33524462DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Days
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2020
First Posted
May 1, 2020
Study Start
April 17, 2020
Primary Completion
June 4, 2020
Study Completion
June 5, 2020
Last Updated
June 9, 2020
Record last verified: 2020-06