Long QT Syndrome
Conditions
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.
Interventions
DEVICEQTc Meter
Development and evaluation of an inexpensive diagnostic device (the QTc Meter) to support simplified widespread screening in the primary care environment for both congenital long QT syndrome (LQTS) and acquired/drug induced-LQTS.
Sponsors
Blue Ox Healthcare Partners
Minnesota Health Solutions
iCardiac Technologies, Inc.
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Low Cost QTc Meter for Long QT Syndrome Screening | Baseline | Number of subjects to have a successful tracing recorded with the QTc Meter in Participants with or without Long QT Syndrome between the ages of 0 and 5 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| QTc Meter Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device
QTc Meter: Development and evaluation of an inexpensive diagnostic device (the QTc Meter) to support simplified widespread screening in the primary care environment for both congenital long QT syndrome (LQTS) and acquired/drug induced-LQTS. | 28 |
| QTc Meter - Healthy Controls Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device.
QTc Meter: Development and evaluation of an inexpensive diagnostic device (the QTc Meter) to support simplified widespread screening in the primary care environment for both congenital long QT syndrome (LQTS) and acquired/drug induced-LQTS. | 5 |
| Total | 33 |
Baseline characteristics
| Characteristic | QTc Meter | Total | QTc Meter - Healthy Controls |
|---|---|---|---|
| Age, Continuous | 2.2 years STANDARD_DEVIATION 1.5 | 2.2 years STANDARD_DEVIATION 1.5 | 2.8 years STANDARD_DEVIATION 1.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 31 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 27 Participants | 30 Participants | 3 Participants |
| Region of Enrollment United States | 28 participants | 33 participants | 5 participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 1 Participants |
| Sex: Female, Male Male | 13 Participants | 17 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 5 |
| other Total, other adverse events | 0 / 28 | 0 / 5 |
| serious Total, serious adverse events | 0 / 28 | 0 / 5 |
Outcome results
Primary
Low Cost QTc Meter for Long QT Syndrome Screening
Number of subjects to have a successful tracing recorded with the QTc Meter in Participants with or without Long QT Syndrome between the ages of 0 and 5
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QTc Meter | Low Cost QTc Meter for Long QT Syndrome Screening | 20 Participants |
| QTc Meter - Healthy Controls | Low Cost QTc Meter for Long QT Syndrome Screening | 4 Participants |