Trial Outcomes & Findings for Low Cost QTc Meter for Long QT Syndrome Screening in Primary Care (NCT NCT04441892)
NCT ID: NCT04441892
Last Updated: 2023-07-25
Results Overview
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
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
Baseline
Results posted on
2023-07-25
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
5
|
|
Overall Study
COMPLETED
|
28
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low Cost QTc Meter for Long QT Syndrome Screening in Primary Care
Baseline characteristics by cohort
| Measure |
QTc Meter
n=28 Participants
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.
|
QTc Meter - Healthy Controls
n=5 Participants
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.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
2.2 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
2.8 years
STANDARD_DEVIATION 1.6 • n=7 Participants
|
2.2 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
5 participants
n=7 Participants
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineNumber 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
Outcome measures
| Measure |
QTc Meter
n=28 Participants
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.
|
QTc Meter - Healthy Controls
n=5 Participants
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.
|
|---|---|---|
|
Low Cost QTc Meter for Long QT Syndrome Screening
|
20 Participants
|
4 Participants
|
Adverse Events
QTc Meter
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
QTc Meter - Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place