Sudden Cardiac Death - Screening Of Risk Factors

Cardiomyopathies Clinical Trial

— SCD-SOS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01845909
• Other study ID #: SCD-SOS
• Status: Active, not recruiting
• Phase: N/A
• First received: April 27, 2013
• Last updated: June 9, 2017
• Start date: February 2012
• Est. completion date: December 2017

Study information

• Verified date: June 2017
• Source: University of Coimbra
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15351
• Est. completion date: December 2017
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 40 Years

Eligibility

Inclusion Criteria:

• 12 to 40 years of age

• Providing an informed consent

Exclusion Criteria:

• Failure to meet any of the aforementioned inclusion criteria

Related Conditions & MeSH terms

• Cardiomyopathies
• Channelopathies
• Death
• Death, Sudden, Cardiac
• Sudden Cardiac Death

Intervention

Other:
• ECG and survey screening

Locations

Country	Name	City	State
Portugal	Unidade Móvel - Tenda de Rastreio - SCDSOS	Coimbra	State...

Sponsors (4)

Lead Sponsor	Collaborator
University of Coimbra	Administração Regional de Saúde do Centro, Centro Hospitalar e Universitário de Coimbra, Medtronic

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	all-cause mortality	occurrence of death of any cause in the participant	First 20 years after enrollement
Primary	Cardiovascular death	Occurrence of death of cardiovascular etiology during follow-up.	First 20 years after enrollement