Low Cost QTc Meter for Long QT Syndrome Screening in Primary Care

Status Terminated

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04441892
Study type	Interventional
Source	Mayo Clinic
Contact
Status	Terminated
Phase	N/A
Start date	February 7, 2019
Completion date	March 26, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04169100` - Novel Form of Acquired Long QT Syndrome	Phase 4
Completed	`NCT01648205` - Long-term Efficacy Study of Sodium Channel Blocker in LQT3 Patients	Phase 2
Recruiting	`NCT06087367` - Building of a Diagnostic/Prognostic Database for Human ERG Variant Effects
Recruiting	`NCT04675788` - Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening	Phase 4
Completed	`NCT05759962` - Phase 1 Study of LQT-1213 in Healthy Adults	Phase 1
Enrolling by invitation	`NCT05903313` - A Study to Evaluate Accuracy and Validity of the Chang Gung ECG Abnormality Detection Software
Terminated	`NCT02439645` - A Registry to Determine the Clinical and Genetic Risk Factors for Torsade De Pointes
Recruiting	`NCT00221832` - Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases	N/A
Completed	`NCT04706104` - QT Measurement Techniques and Anesthesia Management
Recruiting	`NCT04336644` - Continuous Versus Intermittent cARdiac Electrical moNitorinG	N/A
Recruiting	`NCT02814981` - Hydroxyzine and Risk of Prolongation of QT Interval	N/A
Completed	`NCT02876380` - Prospective Identification of Long QT Syndrome in Fetal Life
Completed	`NCT02425189` - The Canadian National Long QT Syndrome Registry
Completed	`NCT00399412` - ECG Signal Collection From Long QT Syndrome, Wide QRS Complexes, Heart Failure, and Cardiac Resynchronization Patients	N/A
Completed	`NCT02513940` - Influence of Testosterone Administration on Drug-Induced QT Interval Prolongation and Torsades de Pointes	Phase 4
Completed	`NCT02441829` - Pharmacokinetics of Eleclazine in Adults With Normal and Impaired Renal Function	Phase 1
Completed	`NCT03182777` - Safety of Local Dental Anesthesia in Patients With Cardiac Channelopathies	N/A
Completed	`NCT01849003` - Study of the Effect of GS-6615 in Subjects With LQT-3	Phase 1
Completed	`NCT00316459` - Study Evaluating the Effects of Multiple Oral Doses of ERB-041 on Cardiac Repolarization in Healthy Subjects	Phase 1
Completed	`NCT00292032` - Registry of Unexplained Cardiac Arrest

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.