Clinical trial NCT04441892: Low Cost QTc Meter for Long QT Syndrome Screening in Primary Care
Official title: Phase II Novel Low Cost QTc Meter for Long QT Syndrome Screening in Primary Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Long QT Syndrome
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Blue Ox Healthcare Partners
name: Minnesota Health Solutions
name: iCardiac Technologies, Inc.
First posted: 2020-06-22
Enrollment: 33
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this study is to further develop and evaluate a diagnostic procedure suitable for use in an inexpensive diagnostic instrument suitable for screening for Long QT Syndrome (LQTS) in the primary care environment.

Detailed description: The study will involve acquiring ECG data in a cohort of up to 1,000 newborns and infants (500 controls (non-LQTS) and 500 LQTS newborns and infants) that are being seen in the Gonda SL ECG Lab (or Baldwin Building)and enrolled during their appointment for a clinically indicated 12-lead ECG. A second arm of Phase II of this study will include approaching 50 healthy subjects at the Baldwin Building to seek interest in participation which will consist of (1) 30 second device recording to help further calibrate and test the device for optimal enhancement. These 50 subjects will not be required to have a clinical or research 12-lead ECG as the investigators will be simply testing the efficiency and accuracy of the device. LQTS will be studied in order to assess the ability of the LQTS screener to accurately detect a patient with established QT prolongation in the context of distinct and varied T wave morphologies The advanced prototype will be placed in the same manner as the device used in Phase I of the study by being lightly placed on the child as pictured below. Similarly, the investigators will use ultrasound gel to obtain a better reading, if applicable. Once completed, a photograph of the torso of the child will be taken from the same views as before (one aerial view and one side view) with neither the head nor the face in the picture. Coded ECG-tracings will be transmitted to the app and shared with Blue Ox Health Corporation and Minnesota Health Solutions as done previously in phase I. Additionally, coded tracings and data from the 12-lead ECG will be shared with Blue Ox Health Corporation and Minnesota Health Solutions to aid in comparison to device tracings and optimization of the algorithm. The 12-lead ECG will be obtained from the subject's medical record and coded before being shared with collaborators. Study coordinators will also review the patient's medical record to determine whether the participants have been diagnosed with a genetic disease.

Eligibility criteria: Inclusion Criteria:

* Infants (Day 0 - 5 years).
* Long QT Syndrome(LQTS).
* Newborns without LQTS (Controls).
* Parental willingness to provide informed consent and follow the study protocol.

Exclusion Criteria:

* Children \> 5 years old.
* Those with genetically elusive LQTS.
* Infants with congenital heart disease.
* Infants born \< 32 weeks EGA.
* Patients with a cardiac device implant (pacemaker/ICD).

Primary outcomes:
measure: Low Cost QTc Meter for Long QT Syndrome Screening
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael Ackerman, MD
role: PRINCIPAL_INVESTIGATOR
References: