Trial record 2 of 23 for:    "Long QT syndrome"

Multicenter Evaluation of Children and Young Adults With Genotype Positive Long QT Syndrome

This study is currently recruiting participants.
Verified March 2014 by Pediatrix Medical Group
Sponsor:
Information provided by (Responsible Party):
Pediatrix Medical Group
ClinicalTrials.gov Identifier:
NCT01705925
First received: October 4, 2012
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

The purpose of the study is to provide comprehensive follow-up in patients with Long QT Syndrome (LQTS) and gain additional information regarding genotype-phenotype correlation and effective management and treatment options.


Condition
Long QT Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Multicenter Evaluation of Children and Young Adults With Genotype Positive Long QT Syndrome

Resource links provided by NLM:


Further study details as provided by Pediatrix Medical Group:

Primary Outcome Measures:
  • Adverse Cardiac Events on patients with genotype positive LQT1 who have a normal EKG and absence of symptoms, but a molecular confirmation of LQT1. [ Time Frame: Enrollment is expected to take approximately 5 years. The patients will be followed until they are no longer cared for by a pediatric cardiology facility (typically post-college) or approximately 21 years of age. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Cardiac Events on patients with both phenotype and genotype positive. [ Time Frame: Enrollment is expected to take approximately 5 years. The patients will be followed until they are no longer cared for by a pediatric cardiology facility (typically post-college) or approximately 21 years of age. ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: March 2012
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children and Young Adults with Genotype Positive Long QT Syndrome

Criteria

Inclusion Criteria:

  • Children and/or young adults diagnosed with heterogeneous repolarization disorder who have genotype positive Long QT, or
  • Newly diagnosed mutation positive patients with a confirmed test

Exclusion Criteria:

  • Children who are phenotypically positive with no molecular testing
  • Children that are phenotypically positive but genotype negative
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01705925

Contacts
Contact: Amy Kelleher, MSHS amy_kelleher@pediatrix.com

Locations
United States, Arizona
Arizona Pediatric Cardiology Consultants Recruiting
Phoenix, Arizona, United States, 85006
Contact: Mitchell Cohen, MD    602-253-6000    mitchell_cohen@pediatrix.com   
Principal Investigator: Mitchell Cohen, MD         
United States, Florida
Pediatric Cardiology Associates St. Petersburg Clinic Recruiting
St. Petersburg, Florida, United States, 33701
Contact: Jorge McCormack, MD    727-767-4200    jorge_mccormack@pediatrix.com   
Principal Investigator: Jorge McCormack, MD         
United States, New Mexico
Children's Cardiology Associates Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Steven Yabek, MD    505-848-3700    steve_yabek@pediatrix.com   
Principal Investigator: Steven Yabek, MD         
United States, Texas
Children's Cardiology Associates Recruiting
Austin, Texas, United States, 78756
Contact: Arnold Fenrich, MD    512-480-0143    arnold_fenrich@pediatrix.com   
Principal Investigator: Arnold Fenrich, MD         
Sponsors and Collaborators
Pediatrix Medical Group
Investigators
Principal Investigator: Mitchell Cohen, M.D. Pediatrix Medical Group
Principal Investigator: Alan Spitzer, MD Pediatrix Medical Group
  More Information

No publications provided

Responsible Party: Pediatrix Medical Group
ClinicalTrials.gov Identifier: NCT01705925     History of Changes
Other Study ID Numbers: PDX-002-11
Study First Received: October 4, 2012
Last Updated: March 6, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 16, 2014