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Sudden Cardiac Death - Screening Of Risk Factors

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01845909
Acronym
SCD-SOS
Enrollment
15351
Registered
2013-05-03
Start date
2012-02-29
Completion date
2017-12-31
Last updated
2017-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathies, Channelopathies, Sudden Cardiac Death

Keywords

Sudden cardiac death, Young adults, Cardiac Disease, Arrhythmia, Sports

Brief summary

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

Interventions

OTHERECG and survey screening

Sponsors

Unidade Local de Saúde de Coimbra, EPE
CollaboratorOTHER
Administração Regional de Saúde do Centro
CollaboratorOTHER
Medtronic
CollaboratorINDUSTRY
University of Coimbra
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Failure to meet any of the aforementioned inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
Type 1 electrocardiogrambaselinePresence 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 FlagBaselinePresence 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 mortalityFirst 20 years after enrollementoccurrence of death of any cause in the participant
Cardiovascular deathFirst 20 years after enrollementOccurrence of death of cardiovascular etiology during follow-up.

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026