Sudden Cardiac Death - Screening Of Risk Factors

NCT ID: NCT01845909

Last Updated: 2017-06-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 15351 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2017-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

young adults - Central region of Portugal

ECG and survey screening

Intervention Type: OTHER

Interventions

ECG and survey screening

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Unidade Local de Saúde de Coimbra, EPE

OTHER

Sponsor Role: collaborator

Administração Regional de Saúde do Centro

OTHER

Sponsor Role: collaborator

Medtronic

INDUSTRY

Sponsor Role: collaborator

University of Coimbra

OTHER

Sponsor Role: lead

Responsible Party

Rui Providência

M.D. M.Sc.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rui Providência, M.D. M.Sc.

Role: STUDY_CHAIR

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

Locations

Unidade Móvel - Tenda de Rastreio - SCDSOS

Coimbra, State..., Portugal

Countries

Portugal

Other Identifiers

SCD-SOS

Identifier Type: -

Identifier Source: org_study_id