Genomics of Sudden Cardiac Arrest

NCT ID: NCT00661128

Last Updated: 2023-06-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 14862 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2030-08-31

Brief 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. 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.

Conditions

Death, Sudden, Cardiac

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

1

European American people who have experienced SCA.

No interventions assigned to this group

2

European American people who have not experienced SCA.

No interventions assigned to this group

3

African American people who have experienced SCA.

No interventions assigned to this group

4

African American people who have not experienced SCA.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Experienced incident SCA

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

Exclusion Criteria

• Members of a vulnerable population

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

King County Emergency Medical Services

UNKNOWN

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Nona Sotoodehnia

Associate Professor of Medicine, Medicine/Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nona Sotoodehnia, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Cardiovascular Health Research Unit, University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

1R01HL088456

Identifier Type: NIH

Identifier Source: secondary_id

View Link

35496

Identifier Type: -

Identifier Source: org_study_id