Medications and the Risk of Sudden Cardiac Death
2 other identifiers
observational
1,200
0 countries
N/A
Brief Summary
To investigate a potential relationship between four different classes of non-cardiovascular drugs and the risk of sudden cardiac death.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2005
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 17, 2005
CompletedFirst Posted
Study publicly available on registry
October 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJune 5, 2017
June 1, 2017
10.7 years
October 17, 2005
June 2, 2017
Conditions
Eligibility Criteria
: We will conduct a retrospective cohort study of Tennessee Medicaid enrollees 30 years of age or older who meet the study inclusion-exclusion criteria. From the Medicaid pharmacy files, we will identify users of study drugs and controls. During followup, we will identify out-of-hospital deaths, most likely to be sudden deaths, based in part on linkage with Tennessee death certificate files. From these deaths, we will identify those meeting the criteria for sudden cardiac death, based upon a previously validated computer algorithm. Important potential confounders will be identified from past medical care encounters, as identified from Medicaid inpatient (augmented with the Tennessee Hospital Discharge dataset), outpatient, and nursing home files. Adjusted estimates of the relative risk will be calculated from multivariate regression analyses.
You may not qualify if:
- Patients with life-threatening illnesses will be excluded because for such persons it is not possible to distinguish from deaths related to arrhythmias versus those that are a consequence of the underlying serious illness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wayne Ray
Vanderbilt University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 17, 2005
First Posted
October 19, 2005
Study Start
September 1, 2005
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
June 5, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share