← Back to Search

Parent Performing ECG (PPE) for Long QT Syndrome

Phase 2
Waitlist Available
Led By Ruey-Kang Chang, M.D., M.P.H.
Research Sponsored by QT Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 to 24 months (within 6 months after the clinical trial is completed)
Awards & highlights

Study Summary

The purpose of this project is to test a new, very compact, 12-lead ECG device as a way to detect long QT syndrome (LQTS) in infants. The device -- called QTScreen -- was developed in Phase I of this project. In Phase II, the goals are to test the capacity of the device for LQTS screening in newborns and to obtain prevalence data on LQTS in California. The 4 main objectives are: To validate the capacity of QTScreen for LQTS screening in newborns. To determine the extent to which parents are able to use QTScreen on their babies at home. To survey end-user experience and opinions. To estimate the LQTS prevalence in California.

Eligible Conditions
  • Long QT Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 to 24 months (within 6 months after the clinical trial is completed)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 to 24 months (within 6 months after the clinical trial is completed) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine LQTS risk via QTc Measurement and family/personal history
Determine if parents are able to use QTScreen on babies at home
Secondary outcome measures
Estimate the LQTS prevalence in California
Follow-up for false negatives and survey end-user experience

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Parent Performing ECG (PPE)Experimental Treatment1 Intervention
Parent Performing ECG (PPE) Group--When the baby is 2 weeks old, research staff will contact interested parents to schedule a home visit. During the visit, a research assistant will provide the parents with a kit that includes the QTScreen system and instructions. The parents will perform an ECG on their child using the QTScreen and instructions. If after attempting the ECG on their own parents encounter problems, parents can ask the research assistant for assistance.
Group II: Staff Performing ECG (SPE)Active Control1 Intervention
Staff Performing ECG (SPE) Group--When the baby is 2-4 weeks of age, research staff will contact the family to schedule a home visit. The QTScreen test will be done by a research assistant.

Find a Location

Who is running the clinical trial?

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterOTHER
101 Previous Clinical Trials
42,301 Total Patients Enrolled
QT Medical, Inc.Lead Sponsor
University of California, IrvineOTHER
543 Previous Clinical Trials
1,919,001 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Journal of Biomedical InformaticsJournal
Research Electronic Data Capture (redcap)—a Metadata-driven Methodology and Workflow Process for Providing Translational Research Informatics Support
Harris, Paul A., Robert Taylor, Robert Thielke, Jonathon Payne, Nathaniel Gonzalez, and Jose G. Conde. 2009. “Research Electronic Data Capture (redcap)—a Metadata-driven Methodology and Workflow Process for Providing Translational Research Informatics Support”. Journal of Biomedical Informatics. Elsevier BV. doi:10.1016/j.jbi.2008.08.010.
clinicaltrials.govStudy
Long QT Syndrome Screening in Newborns
Ruey-Kang Chang 2015. "Long QT Syndrome Screening in Newborns". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02412709.
All > Long Qt Syndrome
~407 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top