Sudden Cardiac Death - Screening Of Risk Factors (SCD-SOS)
|ClinicalTrials.gov Identifier: NCT01845909|
Recruitment Status : Active, not recruiting
First Posted : May 3, 2013
Last Update Posted : June 12, 2017
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
|Condition or disease||Intervention/treatment|
|Sudden Cardiac Death Cardiomyopathies Channelopathies||Other: ECG and survey screening|
|Study Type :||Observational|
|Actual Enrollment :||15351 participants|
|Official Title:||Sudden Cardiac Death: Evaluation of a New Strategy to Identify Young Adults at Risk|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||May 2013|
|Estimated Study Completion Date :||December 2017|
|young adults - Central region of Portugal||Other: ECG and survey screening|
- Type 1 electrocardiogram [ Time Frame: 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
- Clinical History - Red Flag [ Time Frame: 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
- all-cause mortality [ Time Frame: First 20 years after enrollement ]occurrence of death of any cause in the participant
- Cardiovascular death [ Time Frame: First 20 years after enrollement ]Occurrence of death of cardiovascular etiology during follow-up.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01845909
|Unidade Móvel - Tenda de Rastreio - SCDSOS|
|Coimbra, State..., Portugal, 3000|
|Study Chair:||Rui Providência, M.D. M.Sc.||Coimbra's Hospital Centre and University; Faculty of Medicine, University of Coimbra, Portugal|