Sudden Cardiac Death - Screening Of Risk Factors

NCT01845909 | Unknown

• 1 other identifier: SCD-SOS
• Study Type: observational
• Target: 15,351
• Locations: 1 country
• Sites: 1

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

Conditions

Sudden Cardiac Death; Cardiomyopathies; Channelopathies

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

young adults - Central region of Portugal

Other: ECG and survey screening

Interventions

ECG and survey screening OTHER

young adults - Central region of Portugal

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• to 40 years of age
• Providing an informed consent

Sponsors & Collaborators

• University of Coimbra: lead
• Unidade Local de Saúde de Coimbra, EPE: collaborator
• Administração Regional de Saúde do Centro: collaborator
• Medtronic: collaborator

Study Sites (1)

Unidade Móvel - Tenda de Rastreio - SCDSOS

Coimbra, State..., 3000, Portugal

Location

MeSH Terms

Conditions

Death, Sudden, Cardiac; Cardiomyopathies; Channelopathies; Heart Diseases; Arrhythmias, Cardiac

Interventions

epicatechin gallate

Condition Hierarchy (Ancestors)

Heart Arrest; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rui Providência, M.D. M.Sc.

  Coimbra's Hospital Centre and University; Faculty of Medicine, University of Coimbra, Portugal

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. M.Sc.

Study Record Dates

• First Submitted: April 27, 2013
• First Posted: May 3, 2013
• Study Start: February 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: December 1, 2017
• Last Updated: June 12, 2017

Record last verified: 2017-06

Locations

PT (1)