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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01845909
Recruitment Status : Active, not recruiting
First Posted : May 3, 2013
Last Update Posted : June 12, 2017
Centro Hospitalar e Universitário de Coimbra, E.P.E.
Administração Regional de Saúde do Centro
Information provided by (Responsible Party):
Rui Providência, University of Coimbra

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

Condition or disease Intervention/treatment
Sudden Cardiac Death Cardiomyopathies Channelopathies Other: ECG and survey screening

Study Type : Observational
Actual Enrollment : 15351 participants
Observational Model: Cohort
Time Perspective: Prospective
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

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

Primary Outcome Measures :
  1. 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

  2. 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

  3. all-cause mortality [ Time Frame: First 20 years after enrollement ]
    occurrence of death of any cause in the participant

  4. Cardiovascular death [ Time Frame: First 20 years after enrollement ]
    Occurrence of death of cardiovascular etiology during follow-up.

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Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Inclusion Criteria:

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

Exclusion Criteria:

  • Failure to meet any of the aforementioned inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01845909

Unidade Móvel - Tenda de Rastreio - SCDSOS
Coimbra, State..., Portugal, 3000
Sponsors and Collaborators
University of Coimbra
Centro Hospitalar e Universitário de Coimbra, E.P.E.
Administração Regional de Saúde do Centro
Study Chair: Rui Providência, M.D. M.Sc. Coimbra's Hospital Centre and University; Faculty of Medicine, University of Coimbra, Portugal

Responsible Party: Rui Providência, M.D. M.Sc., University of Coimbra Identifier: NCT01845909     History of Changes
Other Study ID Numbers: SCD-SOS
First Posted: May 3, 2013    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017

Keywords provided by Rui Providência, University of Coimbra:
Sudden cardiac death
Young adults
Cardiac Disease

Additional relevant MeSH terms:
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Arrest
Death, Sudden