National Long QT Syndrome Registry: Canadian Genetic Heart Rhythm Network |Research Data Registry and Bio Bank
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,051
- 试验地点
- 1
- 主要终点
- Natural Course of Long QT
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All age groups will be included
- •Gene-positive LQTS patients
- •Gene negative LQTS patients with confirmed phenotypic diagnosis of LQTS (Schwartz score ≥4)
- •Genotype- or phenotype- negative family members of gene- or phenotype- positive LQTS patients evaluated as part of family screening (cascade screening)
- •Informed and willing consent
- •Geneotype- and phenotype-negative patients without an affected family member 2 .Unwilling or unable to provide informed consent
排除标准
- 未提供
结局指标
主要结局
Natural Course of Long QT
时间窗: Three Years
Changes to diagnosis, medications, treatments.
次要结局
未报告次要终点
研究者
Andrew Krahn
Professor of Medicine and Head UBC Division of Cardiology
University of British Columbia