Long QT SyndromeNCT04441892
Low Cost QTc Meter for Long QT Syndrome Screening in Primary Care
A study testing QTc Meter in people with Long QT Syndrome, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Long QT Syndrome
- What is being tested?
- QTc Meter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2019to 26 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants (Day 0 - 5 years).
- Long QT Syndrome(LQTS).
- Newborns without LQTS (Controls).
- Parental willingness to provide informed consent and follow the study protocol.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Phase II Novel Low Cost QTc Meter for Long QT Syndrome Screening in Primary Care
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.
Read the 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.
- Conditions
- Long QT Syndrome
- Being tested
- QTc Meter
- Medical subject headings
- Long QT Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QTc MeterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| QTc Meter | Experimental | 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 Receives: Device: QTc Meter |
| QTc Meter - Healthy Controls | Experimental | 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. Receives: Device: QTc Meter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start7 Feb 2019
- Primary completion26 Mar 2020
- Study completion26 Mar 2020
Why it stopped: COVID, lack of funding and interruption of patient recruitment led to ending the study early.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Long QT SyndromeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Ox Healthcare Partners, Minnesota Health Solutions, iCardiac Technologies, Inc.
- Responsible party
- Principal investigator, Michael J. Ackerman, Mayo Clinic
- Investigators
- Michael Ackerman, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441892
- Sponsor's protocol ID
- 18-006014
- Status last verified
- Jul 2023
- First submitted
- 17 Jun 2020
- Last updated
- 25 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Novel Low Cost QTc Meter for Long QT Syndrome Screening in Primary Care
- ClinicalTrials.gov ID
- NCT04441892
- Acronym / sponsor ID
- 18-006014
- Conditions
- Long QT Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID, lack of funding and interruption of patient recruitment led to ending the study early.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Blue Ox Healthcare Partners, Minnesota Health Solutions, iCardiac Technologies, Inc.
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 26 Mar 2020 (actual)
- Study completion
- 26 Mar 2020 (actual)
- First posted
- 22 Jun 2020 (actual)
- Results
- Posted 25 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QTc Meter | Experimental | Device: QTc MeterInfants/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 - Healthy Controls | Experimental | Device: QTc MeterInfants/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. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants (Day 0 - 5 years).
- Long QT Syndrome(LQTS).
- Newborns without LQTS (Controls).
- Parental willingness to provide informed consent and follow the study protocol.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QTc MeterDevelopment 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. | Device | QTc Meter, QTc Meter - Healthy Controls |
Primary outcome
Low Cost QTc Meter for Long QT Syndrome Screening
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Ackerman, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QTc Meter in people with Long QT Syndrome, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low Cost QTc Meter for Long QT Syndrome Screening (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.