Sudden Cardiac DeathSCD-SOSNCT01845909
Sudden Cardiac Death - Screening Of Risk Factors
An observational study of Sudden Cardiac Death and Cardiomyopathies, run by University of Coimbra at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 12 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sudden Cardiac Death, Cardiomyopathies, Channelopathies
- What is being tested?
- ECG and survey screening
- How many people
- 15,351 participants
- Where
- 1 sitePortugal
- Study dates
- Feb 2012to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 12 to 40 years of age
- Providing an informed consent
Who cannot join
- Failure to meet any of the aforementioned inclusion criteria
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Unidade Móvel - Tenda de Rastreio - SCDSOS
Coimbra, State..., 3000
About this study
Official title: Sudden Cardiac Death: Evaluation of a New Strategy to Identify Young Adults at Risk
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.
Read more
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
- Being tested
- ECG and survey screening
- Keywords
- Sudden cardiac death, Young adults, Cardiac Disease, Arrhythmia, Sports
- Medical subject headings
- Death, Sudden, Cardiac, Cardiomyopathies, Channelopathies, Heart Diseases, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG and survey screeningOther
| Study group | Role | What they receive |
|---|---|---|
| young adults - Central region of Portugal | Not described Receives: Other: ECG and survey screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline
all-cause mortality
occurrence of death of any cause in the participant
Measured: First 20 years after enrollement
Cardiovascular death
Occurrence of death of cardiovascular etiology during follow-up.
Measured: First 20 years after enrollement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startFeb 2012
- Primary completionMay 2013
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Cardiac DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,351 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- Unidade Local de Saúde de Coimbra, EPE, Administração Regional de Saúde do Centro, Medtronic
- Responsible party
- Principal investigator, Rui Providência, University of Coimbra
- Investigators
- Rui Providência, M.D. M.Sc., Study chair, Coimbra's Hospital Centre and University; Faculty of Medicine, University of Coimbra, Portugal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845909
- Sponsor's protocol ID
- SCD-SOS
- Acronym
- SCD-SOS
- Status last verified
- Jun 2017
- First submitted
- 27 Apr 2013
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sudden Cardiac Death: Evaluation of a New Strategy to Identify Young Adults at Risk
- ClinicalTrials.gov ID
- NCT01845909
- Acronym / sponsor ID
- SCD-SOS / SCD-SOS
- Conditions
- Sudden Cardiac Death, Cardiomyopathies, Channelopathies
- Keywords
- Sudden cardiac death, Young adults, Cardiac Disease, Arrhythmia, Sports
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,351 participants (actual)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Collaborators
- Unidade Local de Saúde de Coimbra, EPE, Administração Regional de Saúde do Centro, Medtronic
- Study start
- Feb 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 3 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| young adults - Central region of Portugal | – | Other: ECG and survey screening |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 12 to 40 years of age
- Providing an informed consent
Key exclusion criteria (1 listed)
- Failure to meet any of the aforementioned inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG and survey screening | Other | young adults - Central region of Portugal |
Primary outcome
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
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
all-cause mortality
Time frame: First 20 years after enrollement
occurrence of death of any cause in the participant
Cardiovascular death
Time frame: First 20 years after enrollement
Occurrence of death of cardiovascular etiology during follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rui Providência, M.D. M.Sc. study chair
Coimbra's Hospital Centre and University; Faculty of Medicine, University of Coimbra, Portugal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Cardiac Death and Cardiomyopathies, run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type 1 electrocardiogram (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.