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NCT04336644 · ClinicalTrials.gov registry record · NA
Continuous Versus Intermittent cARdiac Electrical moNitorinG
A NA study of Long QT Syndrome and Torsades de Pointe Caused by Drug, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04336644: Recruiting NA study of Long QT Syndrome and Torsades de Pointe Caused by Drug, sponsored by Washington University School of Medicine.
NCT04336644 is a NA study of Long QT Syndrome and Torsades de Pointe Caused by Drug that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 60 participants, below the 673-participant average among 7 other Long QT Syndrome trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04336644, a NA study of Long QT Syndrome and Torsades de Pointe Caused by Drug, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to validate the continuous patch monitoring system to evaluate cardiac arrhythmias in patients receiving drugs that can cause cardiac complications and compare the continuous patch system with standard electrocardiograms (ECGs).
Primary Outcome
* The Bland Altman plot provides a graphical method to compare the question of interest, namely that the measurements derived from the patch monitor are accurate in relation to the gold standard of the ECG. * Each QT measured from the tracing will be plotted against the difference in QT between the tracing and the 12-lead ECG. The acceptable difference between measurement techniques will be set at 5 ms (primary, strict threshold based on FDA recommendations) with a clinically acceptable differen
Conditions Studied
Interventions
- DEVICE BodyGuardian Mini Plus
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-11-21 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
What NCT04336644 shows while recruiting
NCT04336644 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 673-participant average among 7 other Long QT Syndrome trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Long QT Syndrome appearing as the primary indexed condition, and to 1 intervention - of which BodyGuardian Mini Plus is the first listed.
NCT04336644 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT04336644 about?
NCT04336644 is a clinical study titled "Continuous Versus Intermittent cARdiac Electrical moNitorinG". The purpose of this study is to validate the continuous patch monitoring system to evaluate cardiac arrhythmias in patients receiving drugs that can cause cardiac complications and compare the continuous patch system with standard electrocardiograms (ECGs).
What is the current status of trial NCT04336644?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2023-11-21. Estimated completion is 2026-12-31.
What conditions does trial NCT04336644 study?
This clinical trial studies the following conditions: Long QT Syndrome, Torsades de Pointe Caused by Drug.
What interventions are being tested in trial NCT04336644?
The interventions under investigation include: BodyGuardian Mini Plus (DEVICE).
Who is sponsoring clinical trial NCT04336644?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04336644 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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