Expired Study
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Seattle, Washington 98101


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.


Study summary:

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.


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


Study is Available At:


Original ID:

35496


NCT ID:

NCT00661128


Secondary ID:

1R01HL088456


Study Acronym:

GenSCA


Brief Title:

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


Official Title:

Genomics of Sudden Cardiac Arrest


Overall Status:

Enrolling by invitation


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Washington


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

4


Total Enrollment:

8750


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Nona Sotoodehnia, MD, MPH
Principal Investigator
University of Washington

Study Dates

Start Date:September 2007
Completion Date:August 2020
Completion Type:Anticipated
Primary Completion Date:August 2020
Primary Completion Type:Anticipated
Verification Date:April 2017
Last Changed Date:April 17, 2017
First Received Date:April 16, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Genetic factors that may predispose people to develop SCA
Time Frame:Measured throughout the study
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:1
Description:European American people who have experienced SCA.
Study Arm Type:Other
Arm Name:2
Description:European American people who have not experienced SCA.
Study Arm Type:Other
Arm Name:3
Description:African American people who have experienced SCA.
Study Arm Type:Other
Arm Name:4
Description:African American people who have not experienced SCA.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Washington
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Heart, Lung, and Blood Institute (NHLBI)

Samples and Retentions

Sample Retention:Samples With DNA
Description: De-identified white blood cells, red blood cells, plasma, and DNA
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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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