Sudden Cardiac Death: Evaluation of a New Strategy to Identify Young Adults at Risk
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
- 是
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
Rui Providência
M.D. M.Sc.
University of Coimbra
