Multicenter Evaluation of Children and Young Adults With Genotype Positive Long QT Syndrome
This study is currently recruiting participants.
Verified May 2013 by Pediatrix Medical Group
Sponsor:
Pediatrix Medical Group
Information provided by (Responsible Party):
Pediatrix Medical Group
ClinicalTrials.gov Identifier:
NCT01705925
First received: October 4, 2012
Last updated: May 13, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
Andersen-Tawil syndrome
Jervell and Lange-Nielsen syndrome
Romano-Ward syndrome
U.S. FDA Resources
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: | May 13, 2013 |
| 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 May 16, 2013