Evaluating the Genetic Factors That May Lead to Sudden Cardiac Arrest (The GenSCA Study)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
King County Emergency Medical Services
University of California, San Francisco
Group Health
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00661128
First received: April 16, 2008
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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.


Condition
Death, Sudden, Cardiac

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Genomics of Sudden Cardiac Arrest

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Genetic factors that may predispose people to develop SCA [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

De-identified white blood cells, red blood cells, plasma, and DNA


Estimated Enrollment: 8750
Study Start Date: September 2007
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria for People with SCA:

  • Experienced incident SCA

Inclusion Criteria for People without SCA:

  • Matched to people with SCA on age, gender, and ethnicity

Exclusion Criteria for People with SCA and without SCA:

  • Members of a vulnerable population
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661128

Locations
United States, Washington
Cardiovascular Health Research Unit, University of Washington
Seattle, Washington, United States, 98101
Sponsors and Collaborators
University of Washington
King County Emergency Medical Services
University of California, San Francisco
Group Health
Investigators
Principal Investigator: Nona Sotoodehnia, MD, MPH University of Washington
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00661128     History of Changes
Other Study ID Numbers: 1433, 1R01HL088456
Study First Received: April 16, 2008
Last Updated: December 18, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
Sudden Cardiac Arrest

Additional relevant MeSH terms:
Death, Sudden
Death, Sudden, Cardiac
Heart Arrest
Cardiovascular Diseases
Death
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014