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临床试验/NCT01845909
NCT01845909Unknown不适用

Sudden Cardiac Death: Evaluation of a New Strategy to Identify Young Adults at Risk

University of Coimbra1 个研究点 分布在 1 个国家目标入组 15,351 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
15,351
试验地点
1
主要终点
Clinical History - Red Flag

研究概览

简要总结

The investigators have created a way of quickly collecting information in a large scale young population regarding the presence of some severity indicators that may allow us to classify them into: seemingly "low risk" and possible "elevated risk" for the presence of heart disease. It would have to be a short questionnaire, in order to receive a great adherence but that could simultaneously provide precise information, with an adequate description of symptoms and warning signs, in a way that a triage in the young adult population could be performed in the general young adult population in order to select individuals with an indication for personalized clinical evaluation and possible need of complementary diagnostic means. Based on this premise the investigators have developed a fast-response questionnaire named the Sudden Cardiac Death Screening Of risk factorS (SCD-SOS). This questionnaire has already been tested in a population of approximately 1500 young adults, and some changes have been introduced in order to refine its performance.

To best of the investigators knowledge, there are no large scale European surveys estimating the prevalence of cardiac disease and associated clinical symptoms in a non-selected (non-athlete) population of this age group.

Purpose: To screen a young adult population from central regional of Portugal for heart disease possibly associated to a high risk of Sudden Cardiac Death (SCD).

To determine the national prevalence of clinical symptoms of heart disease and of heart disease with increased risk for SCD in this age group.

To detect young adults in risk of SCD and with an indication for evaluation by a cardiologist, and possible need of:

  • medical treatment
  • electrophysiologic (EP) study and percutaneous ablation
  • an implantable cardiovertor defibrillator
  • a pacemaker
  • other type of specialized cardiac intervention

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
12 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 12 to 40 years of age
  • Providing an informed consent

排除标准

  • Failure to meet any of the aforementioned inclusion criteria

结局指标

主要结局

Clinical History - Red Flag

时间窗: Baseline

Presence of answers concerning symptoms or past family history that are known to be associated with increased risk of sudden cardiac death: e.g. effort syncope, syncope with fast palpitations prodrome, know high-risk cardiac disease, history of sudden cardiac death in first or second degree relative

Type 1 electrocardiogram

时间窗: baseline

Presence of ECG changes suggestive of cardiac disease associated with an increased risk of sudden cardiac death. Definition present in: Corrado D et al. Recommendations for interpretation of 12-lead electrocardiogram in the athlete. Eur Heart J 2010;31:243-259

Cardiovascular death

时间窗: First 20 years after enrollement

Occurrence of death of cardiovascular etiology during follow-up.

all-cause mortality

时间窗: First 20 years after enrollement

occurrence of death of any cause in the participant

次要结局

未报告次要终点

研究者

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

Rui Providência

M.D. M.Sc.

University of Coimbra

研究点 (1)

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