An observational study in Sudden Cardiac Death, Cardiomyopathies and Channelopathies, sponsored by University of Coimbra. Status unknown at 1 site in Portugal. Open to participants aged 12 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-12.
Sponsored by University of Coimbra · Observational
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:
1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.
This study's enrollment of 15,351 is above the median of 153 across 515 observational studies indexed under Cardiomyopathies.
Browse Cardiomyopathies studies →University of Coimbra is the lead sponsor of 84 studies on the registry; 25 are open to participants now.
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Recruitment will include mainly university students but also young adults involved in sport practice (professional, semi-professional and amateur athletes) or in other activities (sales, industry, etc). This way, the places for sample collection will the university departments or technical schools, students associations and other places that gather university students, shopping centers, gyms, sports venues, factories in the city surroundings. Information collection in these places will be performed under the authorization of proper entities.
Exclusion Criteria:
Other: ECG and survey screening
Type 1 electrocardiogram
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
Time frame: baseline
Clinical History - Red Flag
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
Time frame: Baseline
all-cause mortality
occurrence of death of any cause in the participant
Time frame: First 20 years after enrollement
Cardiovascular death
Occurrence of death of cardiovascular etiology during follow-up.
Time frame: First 20 years after enrollement
This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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University of Coimbra