Clinical Trial: The Canadian National Long QT Syndrome Registry
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]
Official Title: National Long QT Syndrome Registry: Canadian Genetic Heart Rhythm Network |Research Data Registry and Bio Bank
Brief Summary:
The NLQTS Research Network team aims to build a Canadian collaboration of dedicated investigators that will create a new paradigm in the modern investigation of patients with LQTS and in the description of a new disease modifier.
The project aims to describe the natural history of familial Long QT Syndrome to identify:
- Low risk patients that do not require protective beta-blocker therapy
- High-risk patients that require protective beta-blocker therapy and may benefit from a primary prevention ICD. This cohort would contain treated pre-symptomatic individuals effectively protected from harm.
Detailed Summary:
Methods Patients with positive LQTS diagnosis and their family members reviewed in collaborating Canadian Inherited Arrhythmia Clinics will be invited to participate in the registry.
Optional bio bank donation will be offered. Consenting participants will have blood work drawn in their local outpatient laboratory.
Bio banking at other collaborating centres will be done only at centres that have their own bio banking facility at the site investigator's discretion. There will be no central bio banking on a national basis at this time for this project.
Optional Post Mortem Consent:
The next of kin (NOK) may provide consent to include the healthcare information of the deceased family member into the data registry. The NOK may also consent to the storage of any post mortem tissue not required for clinical testing to be stored in the bio bank for future research.
Data Collected Clinical data will be collected from willing/consented registry participants. Their healthcare information will be coded in compliance with Tri Council Policy Statement criteria: direct identifiers will be removed and replaced with a unique study code that does not use personal information such as the participant's birth day (month and year will be included), health number, social insurance number or name/initials. The coded data will be transferred into the research database.
The master list of registry participants with their study identifiers will be kept separately from the research database. This master list will be stored in an encrypted file within the research office of each site investigators under their supervision. Only the site investigators and t
Sponsor: Andrew Krahn
Current Primary Outcome: Natural Course of Long QT [ Time Frame: Three Years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of British Columbia
Dates:
Date Received: November 13, 2014
Date Started: November 2014
Date Completion: December 2021
Last Updated: May 16, 2016
Last Verified: May 2016
