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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University of Coimbra
Sponsor:
Collaborators:
Centro Hospitalar e Universitário de Coimbra
Administração Regional de Saúde do Centro
Medtronic
Information provided by (Responsible Party):
Rui Providência, University of Coimbra
ClinicalTrials.gov Identifier:
NCT01845909
First received: April 27, 2013
Last updated: May 2, 2013
Last verified: April 2013
  Purpose

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 Intervention
Sudden Cardiac Death
Cardiomyopathies
Channelopathies
Other: ECG and survey screening

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sudden Cardiac Death: Evaluation of a New Strategy to Identify Young Adults at Risk

Resource links provided by NLM:


Further study details as provided by University of Coimbra:

Primary Outcome Measures:
  • Type 1 electrocardiogram [ Time Frame: baseline ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    occurrence of death of any cause in the participant

  • Cardiovascular death [ Time Frame: First 20 years after enrollement ] [ Designated as safety issue: No ]
    Occurrence of death of cardiovascular etiology during follow-up.


Estimated Enrollment: 15000
Study Start Date: February 2012
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
young adults - Central region of Portugal Other: ECG and survey screening

  Eligibility

Ages Eligible for Study:   12 Years to 40 Years
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Failure to meet any of the aforementioned inclusion criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01845909

Contacts
Contact: Rui Providência, M.D. M.Sc. +351961023760 rui_providencia@yahoo.com

Locations
Portugal
Unidade Móvel - Tenda de Rastreio - SCDSOS Recruiting
Coimbra, State..., Portugal, 3000
Contact: Rui Providência, M.D. M.Sc.    +351961023760    rui_providencia@yahoo.com   
Principal Investigator: Rui Providência, M.D. M.Sc.         
Sponsors and Collaborators
University of Coimbra
Centro Hospitalar e Universitário de Coimbra
Administração Regional de Saúde do Centro
Medtronic
Investigators
Study Chair: Rui Providência, M.D. M.Sc. Coimbra's Hospital Centre and University; Faculty of Medicine, University of Coimbra, Portugal
  More Information

No publications provided

Responsible Party: Rui Providência, M.D. M.Sc., University of Coimbra
ClinicalTrials.gov Identifier: NCT01845909     History of Changes
Other Study ID Numbers: SCD-SOS
Study First Received: April 27, 2013
Last Updated: May 2, 2013
Health Authority: Portugal: Comissão Nacional de Protecção de Dados - Processo 13817/2011; Autorização 12374/2011
Portugal: Administração Regional de Saúde do Centro

Keywords provided by University of Coimbra:
Sudden cardiac death
Young adults
Cardiac Disease
Arrhythmia
Sports

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

ClinicalTrials.gov processed this record on November 27, 2014