NCT00064558

Brief Summary

To evaluate whether genetic variation in selected candidate genes is associated with risk of sudden cardiac death in the general population.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2003

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2003

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

October 7, 2025

Status Verified

October 1, 2025

Enrollment Period

4.9 years

First QC Date

July 8, 2003

Last Update Submit

October 2, 2025

Conditions

Cardiovascular DiseasesHeart DiseasesDeath, Sudden, CardiacVentricular ArrhythmiaArrhythmia

Outcome Measures

Primary Outcomes (1)

  • sequence variation

    To determine if sequence variants in SCN5A, KVLQT1, HERG, KCNE1, KCNE2, and RyR2 genes and other candidate genes are associated with an increased risk of SCD in broader populations.

    Ongoing

Secondary Outcomes (1)

  • Single loci and SCD risk

    Ongoing

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants previously enrolled in the Physicians' Health Study I (Protocol 1999-P-001468), Physicians' Health Study II (Protocols 1999-P-003315, 1999-P-003318), Nurses' Health Study (Protocols 1999-P-01114, 1999-P-010982), Women's Health Study (Protocols 1999-P-001304, 1999-P-001478), Women's Antioxidant Cardiovascular Study (Protocols 1999-P-001364, 1999-P-001611), and Health Professional Health Study approved through the Harvard School of Public Health IRB (Protocols 0007PROC, 0103STOR).

No eligibility criteria.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesDeath, Sudden, CardiacArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart ArrestDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christine M Albert, M.D., M.P.H.

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 8, 2003

First Posted

July 10, 2003

Study Start

July 1, 2003

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

October 7, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share