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Trial record 1 of 74 for:    "Andersen-Tawil syndrome" OR "Long QT Syndrome"
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Long QT Syndrome Screening in Newborns

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ClinicalTrials.gov Identifier: NCT02412709
Recruitment Status : Unknown
Verified September 2016 by Ruey-Kang Chang, QT Medical, Inc..
Recruitment status was:  Recruiting
First Posted : April 9, 2015
Last Update Posted : September 28, 2016
Sponsor:
Collaborators:
Los Angeles Biomedical Research Institute
University of California, Irvine
Information provided by (Responsible Party):
Ruey-Kang Chang, QT Medical, Inc.

Brief Summary:

The purpose of this project is to test a new, very compact, 12-lead ECG device as a way to detect long QT syndrome (LQTS) in infants. The device -- called QTScreen -- was developed in Phase I of this project.

In Phase II, the goals are to test the capacity of the device for LQTS screening in newborns and to obtain prevalence data on LQTS in California.

The 4 main objectives are:

  1. To validate the capacity of QTScreen for LQTS screening in newborns.
  2. To determine the extent to which parents are able to use QTScreen on their babies at home.
  3. To survey end-user experience and opinions.
  4. To estimate the LQTS prevalence in California.

Condition or disease Intervention/treatment Phase
Long QT Syndrome Device: QTScreen ECG Recorder Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: ECG Device for Long QT Syndrome Screening in Newborns
Study Start Date : June 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Parent Performing ECG (PPE)
Parent Performing ECG (PPE) Group--When the baby is 2 weeks old, research staff will contact interested parents to schedule a home visit. During the visit, a research assistant will provide the parents with a kit that includes the QTScreen system and instructions. The parents will perform an ECG on their child using the QTScreen and instructions. If after attempting the ECG on their own parents encounter problems, parents can ask the research assistant for assistance.
Device: QTScreen ECG Recorder
Subjects will be randomly assigned to the: Parents Performing ECG (PPE) group or Staff Performing ECG (SPE) group. This will assess whether parents are able to use QTScreen on babies at home.

Active Comparator: Staff Performing ECG (SPE)
Staff Performing ECG (SPE) Group--When the baby is 2-4 weeks of age, research staff will contact the family to schedule a home visit. The QTScreen test will be done by a research assistant.
Device: QTScreen ECG Recorder
Subjects will be randomly assigned to the: Parents Performing ECG (PPE) group or Staff Performing ECG (SPE) group. This will assess whether parents are able to use QTScreen on babies at home.




Primary Outcome Measures :
  1. Determine LQTS risk via QTc Measurement and family/personal history [ Time Frame: within 1-2 business days after QTScreen recording ]
    A standard 12-lead ECG will be printed from the QTScreen recording. Investigators will manually measure a corrected QT interval (QTc) from lead II, and examine any clinical ECG abnormalities. Subjects with a positive history, or subjects with a median QTc ≥450 ms on the first QTScreen will be categorized as Intermediate Risk and undergo a repeat QTScreen in 2-4 weeks (before 2 months of age).

  2. Determine if parents are able to use QTScreen on babies at home [ Time Frame: 18 to 24 months (within 6 months after the clinical trial is completed) ]
    Participants in the PPE group will be provided with the QTScreen recording device along with instructions for conducting an ECG on their baby. While conducting the ECG, a research assistant will access the parents' ability in properly conducting the ECG via a questionnaire.


Secondary Outcome Measures :
  1. Follow-up for false negatives and survey end-user experience [ Time Frame: at 1 year after LQTS screening ]
    A research assistant will conduct a follow-up of each subject when the subject turns 1 year of age. For subjects <1 year of age when the project ends, the family will be contacted at the end of the project period and when the subject turns 1 year. Parents will be inquired about: any diagnosis of LQTS, heart disease, fainting, seizures, or sudden death (SIDS) after the screening. If a subject had fainting or seizures but no subsequent cardiac evaluation, he/she will be scheduled for a repeat QTScreen. If a subject died of sudden unexplained death or SIDS, the parents will be offered ECG and genetic testing for LQTS. After the follow-up questions, parents will be surveyed on their experience with QTScreen.

  2. Estimate the LQTS prevalence in California [ Time Frame: 18 to 24 months (within 6 months after the clinical trial is completed) ]
    The large sample size and use of genetic conformation in this study provides a unique opportunity to evaluate the LQTS prevalence, as well as differences in certain ethnic groups, such as Latinos and White. The number of subjects with confirmed LQTS includes true positives, identified by positive QTScreen testing followed by gene testing, and false negatives identified by telephone follow up and subsequent confirmation. Prevalence data will be reported as the proportion of subjects with confirmed LQTS (and binomial exact 95% CI).



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Ages Eligible for Study:   up to 4 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Born at ≥36 weeks of gestation.
  2. Birth weight 2.5-4.5 kg

Exclusion Criteria:

  1. Babies that have been born with a heart disease.
  2. Babies who have a skin condition, allergies, or chest deformities making ECG on the chest difficult or impossible.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02412709


Contacts
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Contact: Sandra Sedano, M.S. 424-558-3500 ssedano@qtmedicalinc.com
Contact: Eva M Villa, M.S. 310-222-5383 evilla@labiomed.org

Locations
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United States, California
St. Francis Medical Center Recruiting
Lynwood, California, United States, 90262
Contact: Andy Moosa, M.D.    310-900-2004    andymoosa@dohs.org   
Principal Investigator: Andy Moosa, M.D.         
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center Recruiting
Torrance, California, United States, 90502
Contact: Eva M Villa, M.S.    310-222-5383    evilla@labiomed.org   
Principal Investigator: Henry J Lin, M.D.         
Providence Little Company of Mary Medical Center-Torrance Recruiting
Torrance, California, United States, 90503
Contact: Elaine Shoji, M.D.    310-541-8801    ecsmd@verizon.net   
Principal Investigator: Elaine Shoji, M.D.         
Sponsors and Collaborators
QT Medical, Inc.
Los Angeles Biomedical Research Institute
University of California, Irvine
Investigators
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Principal Investigator: Ruey-Kang Chang, M.D., M.P.H. QT Medical, Inc.

Publications:
Disposable ECG electrodes. ANSI/AAMI EC12. 2000 (R2010)
Rautaharju PM, Surawicz B, Gettes LS, Bailey JJ, Childers R, Deal BJ, Gorgels A, Hancock EW, Josephson M, Kligfield P, Kors JA, Macfarlane P, Mason JW, Mirvis DM, Okin P, Pahlm O, van Herpen G, Wagner GS, Wellens H; American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; American College of Cardiology Foundation; Heart Rhythm Society. AHA/ACCF/HRS recommendations for the standardization and interpretation of the electrocardiogram: part IV: the ST segment, T and U waves, and the QT interval: a scientific statement from the American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; the American College of Cardiology Foundation; and the Heart Rhythm Society. Endorsed by the International Society for Computerized Electrocardiology. J Am Coll Cardiol. 2009 Mar 17;53(11):982-91. doi: 10.1016/j.jacc.2008.12.014. Review.
Arking DE, Pulit SL, Crotti L, van der Harst P, Munroe PB, Koopmann TT, Sotoodehnia N, Rossin EJ, Morley M, Wang X, Johnson AD, Lundby A, Gudbjartsson DF, Noseworthy PA, Eijgelsheim M, Bradford Y, Tarasov KV, Dörr M, Müller-Nurasyid M, Lahtinen AM, Nolte IM, Smith AV, Bis JC, Isaacs A, Newhouse SJ, Evans DS, Post WS, Waggott D, Lyytikäinen LP, Hicks AA, Eisele L, Ellinghaus D, Hayward C, Navarro P, Ulivi S, Tanaka T, Tester DJ, Chatel S, Gustafsson S, Kumari M, Morris RW, Naluai ÅT, Padmanabhan S, Kluttig A, Strohmer B, Panayiotou AG, Torres M, Knoflach M, Hubacek JA, Slowikowski K, Raychaudhuri S, Kumar RD, Harris TB, Launer LJ, Shuldiner AR, Alonso A, Bader JS, Ehret G, Huang H, Kao WH, Strait JB, Macfarlane PW, Brown M, Caulfield MJ, Samani NJ, Kronenberg F, Willeit J; CARe Consortium; COGENT Consortium, Smith JG, Greiser KH, Meyer Zu Schwabedissen H, Werdan K, Carella M, Zelante L, Heckbert SR, Psaty BM, Rotter JI, Kolcic I, Polašek O, Wright AF, Griffin M, Daly MJ; DCCT/EDIC, Arnar DO, Hólm H, Thorsteinsdottir U; eMERGE Consortium, Denny JC, Roden DM, Zuvich RL, Emilsson V, Plump AS, Larson MG, O'Donnell CJ, Yin X, Bobbo M, D'Adamo AP, Iorio A, Sinagra G, Carracedo A, Cummings SR, Nalls MA, Jula A, Kontula KK, Marjamaa A, Oikarinen L, Perola M, Porthan K, Erbel R, Hoffmann P, Jöckel KH, Kälsch H, Nöthen MM; HRGEN Consortium, den Hoed M, Loos RJ, Thelle DS, Gieger C, Meitinger T, Perz S, Peters A, Prucha H, Sinner MF, Waldenberger M, de Boer RA, Franke L, van der Vleuten PA, Beckmann BM, Martens E, Bardai A, Hofman N, Wilde AA, Behr ER, Dalageorgou C, Giudicessi JR, Medeiros-Domingo A, Barc J, Kyndt F, Probst V, Ghidoni A, Insolia R, Hamilton RM, Scherer SW, Brandimarto J, Margulies K, Moravec CE, del Greco M F, Fuchsberger C, O'Connell JR, Lee WK, Watt GC, Campbell H, Wild SH, El Mokhtari NE, Frey N, Asselbergs FW, Mateo Leach I, Navis G, van den Berg MP, van Veldhuisen DJ, Kellis M, Krijthe BP, Franco OH, Hofman A, Kors JA, Uitterlinden AG, Witteman JC, Kedenko L, Lamina C, Oostra BA, Abecasis GR, Lakatta EG, Mulas A, Orrú M, Schlessinger D, Uda M, Markus MR, Völker U, Snieder H, Spector TD, Ärnlöv J, Lind L, Sundström J, Syvänen AC, Kivimaki M, Kähönen M, Mononen N, Raitakari OT, Viikari JS, Adamkova V, Kiechl S, Brion M, Nicolaides AN, Paulweber B, Haerting J, Dominiczak AF, Nyberg F, Whincup PH, Hingorani AD, Schott JJ, Bezzina CR, Ingelsson E, Ferrucci L, Gasparini P, Wilson JF, Rudan I, Franke A, Mühleisen TW, Pramstaller PP, Lehtimäki TJ, Paterson AD, Parsa A, Liu Y, van Duijn CM, Siscovick DS, Gudnason V, Jamshidi Y, Salomaa V, Felix SB, Sanna S, Ritchie MD, Stricker BH, Stefansson K, Boyer LA, Cappola TP, Olsen JV, Lage K, Schwartz PJ, Kääb S, Chakravarti A, Ackerman MJ, Pfeufer A, de Bakker PI, Newton-Cheh C. Genetic association study of QT interval highlights role for calcium signaling pathways in myocardial repolarization. Nat Genet. 2014 Aug;46(8):826-36. doi: 10.1038/ng.3014. Epub 2014 Jun 22.

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Responsible Party: Ruey-Kang Chang, Chief Executive Officer, QT Medical, Inc.
ClinicalTrials.gov Identifier: NCT02412709     History of Changes
Other Study ID Numbers: 30147-01
First Posted: April 9, 2015    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016

Keywords provided by Ruey-Kang Chang, QT Medical, Inc.:
Long QT Syndrome
LQTS
genetic testing
ECG
saliva testing

Additional relevant MeSH terms:
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Long QT Syndrome
Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities