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临床试验/NCT02162992
NCT02162992已完成不适用

Repolarization Disorders and Heart Conduction Disorders in Patients With Systemic Lupus Erythematous

Germans Trias i Pujol Hospital1 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
151
试验地点
1
主要终点
Presence of Conduction Disorders in Patients With SLE Regarding to Its Serologic Profile

研究概览

简要总结

Connective tissue diseases have been related to heart conduction disorders. The anti-Ro/SSA antibodies are thought to have a pathogenic role, and they most prevalent in systemic lupus erythematous (SLE). The aim of this study is to evaluate the relationship between SLE, arrhythmias and its serologic profile.

详细描述

We designed a cross-sectional study for an observational analysis. The target population will be the group of SLE patients visited the service of Rheumatology hospitals in Catalonia (Spain).

The criteria for subjects selection to participate in our project are:

1 . Inclusion criteria: patients with SLE according to established diagnostic criteria in 1997 2. Exclusion criteria:

  • Presence of cardiac: Ischemic heart disease or congenital or acquired structural heart disease (hypertrophic cardiomyopathy, idiopathic dilated cardiomyopathy, valve disease with clinical significance).
  • Background heart surgery or cardiac ablation procedures.
  • Background in other pathological processes has been described affecting cardiac conduction tissue: Steinert's disease, Lyme disease, Chagas' disease with heart involvement or hypothyroidism.

The selection of patients and controls are done through a sampling of consecutive patients seen in our outpatient rheumatology center to achieve the sample size. This has been fixed in two subgroups: 100 patients with SLE and positive for anti-Ro (with positivity for anti-Ro only 52 or positivity for anti-Ro and anti-Ro 52 60) and 50 patients (controls ) with SLE and negative for anti-Ro (anti-Ro52 and anti-Ro 60).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with SLE diagnosis, according to SLE diagnostic criteria.

排除标准

  • Patients with previous cardiac diseases (ischemic heart disease, hypertrophic cardiomyopathy, dilated cardiomyopathy, valvular heart disease)
  • Clinical history of heart surgery or ablation procedures
  • Clinical history of other conditions that affect heart conduction:
  • Steinert Disease
  • Lyme Disease
  • Chagas Disease
  • Hypothyroidism

结局指标

主要结局

Presence of Conduction Disorders in Patients With SLE Regarding to Its Serologic Profile

时间窗: 24 hours

Conduction disorders will be evaluated by 12-lead ECG recordings an 24-hour Holter recordings. Measurements will include PR intervals (in msec), QRS duration (in msec) .

次要结局

  • QT and Corrected QT Intervals(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Roger Villuendas Sabaté

Coordinator of the Electrophysiology and Cardiac Pacing Unit

Germans Trias i Pujol Hospital

研究点 (1)

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