Death, Sudden, CardiacGenSCANCT00661128
Genomics of Sudden Cardiac Arrest
An observational study of Death, Sudden, Cardiac, run by University of Washington at 1 site in United States.
Trial summary
Sudden cardiac arrest (SCA) is a sudden, unexpected loss of heart function. It is a leading cause of death, and more than 400,000 people in the United States die each year as a result of SCA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Death, Sudden, Cardiac
- How many people
- 14,862 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The group of people who have experienced SCA will be selected from participants in the Cardiac Arrest Blood Study (CABS), participants in the Cardiovascular Health Study (CHS), and residents of Seattle and King County, WA who experience SCA. The control group of people who have not experienced SCA will be selected from participants in CABS, participants in the Heart and Vascular Health Study, participants in CHS, and residents of Seattle and King County, WA who have not experienced SCA.
Who may be able to join
- Experienced incident SCA
- Matched to people with SCA on age, gender, and ethnicity
Who cannot join
- Members of a vulnerable population
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiovascular Health Research Unit, University of Washington
Seattle, Washington, 98101
About this study
Official title: Evaluating the Genetic Factors That May Lead to Sudden Cardiac Arrest (The GenSCA Study)
Sudden cardiac arrest (SCA) is a sudden, unexpected loss of heart function. It is a leading cause of death, and more than 400,000 people in the United States die each year as a result of SCA. This study will analyze genetic samples of people who have experienced SCA and people who have not experienced SCA to determine if there is a genetic basis for SCA.
Read the detailed description
SCA occurs when the heart suddenly and unexpectedly stops beating. When this happens, blood stops flowing to the brain and other vital organs. Ninety-five percent of people who experience SCA die from it, most within minutes. SCA is usually caused by abnormal heart rhythms, known as arrhythmias, which can be triggered by several factors, including coronary artery disease, physical stress, and structural changes in the heart. Certain genetic factors may also increase the likelihood of experiencing SCA. Study researchers will analyze genetic samples from people affected by SCA and people unaffected by SCA to identify and characterize genetic variations that are associated with an increased risk of SCA in European Americans and African Americans.
This study will examine previously collected blood samples from people who have experienced SCA and were participants in the Cardiac Arrest Blood Study (CABS) and the Cardiovascular Health Study (CHS). These participants will not attend any study visits or be contacted by study researchers. People who experience SCA in the first 4 years of this study will have blood drawn from paramedics at the time of SCA. If these participants survive, they will be asked whether study researchers can review their medical records. Study researchers will also examine previously collected blood samples from participants who have not experienced SCA and were participants in CABS, CHS, and the Heart and Vascular Health Study. These participants will not attend any study visits or be contacted by study researchers. Study researchers will also enroll a new control group of people who have not experienced SCA. These participants will attend one study visit for blood collection and a medical record review.
- Conditions
- Death, Sudden, Cardiac
- Keywords
- Sudden Cardiac Arrest
- Medical subject headings
- Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | European American people who have experienced SCA. | |
| 2 | European American people who have not experienced SCA. | |
| 3 | African American people who have experienced SCA. | |
| 4 | African American people who have not experienced SCA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic factors that may predispose people to develop SCA
Measured: Measured throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startSep 2007
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Death, Sudden, CardiacStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Other
- Enrolment
- 14,862 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), King County Emergency Medical Services, University of California, San Francisco, Kaiser Permanente
- Responsible party
- Principal investigator, Nona Sotoodehnia, University of Washington
- Investigators
- Nona Sotoodehnia, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661128
- Sponsor's protocol ID
- 35496
- Other IDs
- 1R01HL088456
- Acronym
- GenSCA
- Status last verified
- Jun 2023
- First submitted
- 16 Apr 2008
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Genetic Factors That May Lead to Sudden Cardiac Arrest (The GenSCA Study)
- ClinicalTrials.gov ID
- NCT00661128
- Acronym / sponsor ID
- GenSCA / 35496
- Conditions
- Death, Sudden, Cardiac
- Keywords
- Sudden Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 14,862 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), King County Emergency Medical Services, University of California, San Francisco, Kaiser Permanente
- Study start
- Sep 2007
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 18 Apr 2008 (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.
Sudden cardiac arrest (SCA) is a sudden, unexpected loss of heart function. It is a leading cause of death, and more than 400,000 people in the United States die each year as a result of SCA. This study will analyze genetic samples of people who have experienced SCA and people who have not experienced SCA to determine if there is a genetic basis for SCA.
Detailed description
SCA occurs when the heart suddenly and unexpectedly stops beating. When this happens, blood stops flowing to the brain and other vital organs. Ninety-five percent of people who experience SCA die from it, most within minutes. SCA is usually caused by abnormal heart rhythms, known as arrhythmias, which can be triggered by several factors, including coronary artery disease, physical stress, and structural changes in the heart. Certain genetic factors may also increase the likelihood of experiencing SCA. Study researchers will analyze genetic samples from people affected by SCA and people unaffected by SCA to identify and characterize genetic variations that are associated with an increased risk of SCA in European Americans and African Americans.
This study will examine previously collected blood samples from people who have experienced SCA and were participants in the Cardiac Arrest Blood Study (CABS) and the Cardiovascular Health Study (CHS). These participants will not attend any study visits or be contacted by study researchers. People who experience SCA in the first 4 years of this study will have blood drawn from paramedics at the time of SCA. If these participants survive, they will be asked whether study researchers can review their medical records. Study researchers will also examine previously collected blood samples from participants who have not experienced SCA and were participants in CABS, CHS, and the Heart and Vascular Health Study. These participants will not attend any study visits or be contacted by study researchers. Study researchers will also enroll a new control group of people who have not experienced SCA. These participants will attend one study visit for blood collection and a medical record review.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –European American people who have experienced SCA. |
| 2 | – | –European American people who have not experienced SCA. |
| 3 | – | –African American people who have experienced SCA. |
| 4 | – | –African American people who have not experienced SCA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The group of people who have experienced SCA will be selected from participants in the Cardiac Arrest Blood Study (CABS), participants in the Cardiovascular Health Study (CHS), and residents of Seattle and King County, WA who experience SCA. The control group of people who have not experienced SCA will be selected from participants in CABS, participants in the Heart and Vascular Health Study, participants in CHS, and residents of Seattle and King County, WA who have not experienced SCA.
Key inclusion criteria (2 listed)
- Experienced incident SCA
- Matched to people with SCA on age, gender, and ethnicity
Key exclusion criteria (1 listed)
- Members of a vulnerable population
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genetic factors that may predispose people to develop SCA
Time frame: Measured throughout the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
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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.
Nona Sotoodehnia, MD, MPH principal investigator
University of Washington
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 Death, Sudden, Cardiac, run by University of Washington at 1 site in United States.
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: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2023. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Genetic factors that may predispose people to develop SCA (time frame: Measured throughout the study). 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 5 Jun 2023.