Sudden Cardiac Death - Screening Of Risk Factors (SCD-SOS)

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

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

Study Overview

• Status: Unknown
• Conditions: Cardiomyopathies; Sudden Cardiac Death; Channelopathies
• Intervention / Treatment: Other: ECG and survey screening

• Study Type: Observational
• Enrollment (Actual): 15351

Contacts and Locations

Study Locations

• Portugal
  • State...
    • Coimbra, State..., Portugal, 3000
      • Unidade Móvel - Tenda de Rastreio - SCDSOS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Failure to meet any of the aforementioned inclusion criteria

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
young adults - Central region of Portugal	Other: ECG and survey screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Baseline
all-cause mortality	occurrence of death of any cause in the participant	First 20 years after enrollement
Cardiovascular death	Occurrence of death of cardiovascular etiology during follow-up.	First 20 years after enrollement

Collaborators and Investigators

• Sponsor: University of Coimbra
• Collaborators: Medtronic; Centro Hospitalar e Universitário de Coimbra, E.P.E.; Administração Regional de Saúde do Centro
• Investigators: Study Chair: Rui Providência, M.D. M.Sc., Coimbra's Hospital Centre and University; Faculty of Medicine, University of Coimbra, Portugal

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: April 27, 2013
• First Submitted That Met QC Criteria: May 2, 2013
• First Posted (Estimate): May 3, 2013

Study Record Updates

• Last Update Posted (Actual): June 12, 2017
• Last Update Submitted That Met QC Criteria: June 9, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Arrhythmia; Sudden cardiac death; Young adults; Cardiac Disease; Sports
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Heart Arrest; Death; Cardiomyopathies; Death, Sudden, Cardiac; Channelopathies
• Other Study ID Numbers: SCD-SOS