Status:
COMPLETED
Medications and the Risk of Sudden Cardiac Death
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiovascular Diseases
Heart Diseases
Eligibility:
All Genders
Up to 100 years
Brief Summary
To investigate a potential relationship between four different classes of non-cardiovascular drugs and the risk of sudden cardiac death.
Detailed Description
BACKGROUND: There are more than 400,000 sudden cardiac deaths annually in the U.S, of which 85% or more are caused by ventricular tachyarrhythmias. Medications are an important modifiable risk factor...
Eligibility Criteria
Inclusion
- Study selection criteria are not based on gender, ethnicity or race. Nevertheless, we estimated that 61% of subjects would be females, 73% would be white, and 99% would be non-hispanic/latino.
- Inclusion/exclusion criteria are designed to assure the availability of data necessary for the study and to identify a cohort of patients who, absent adverse medication effects, are at low risk for sudden death. Thus, inclusion criteria require enrollment in TennCare, including access to medications. To assure complete identification of all healthcare encounters and medication use, the study will be restricted to TennCare enrollees with active enrollment and full pharmacy benefits. We require age 30 years or older at the beginning of the study. This is the population for which arrhythmia-related deaths are of greatest concern. Finally, cohort members must have use of study or control medications, as defined by filling at least one prescription recorded in the Medicaid pharmacy files.
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00241800
Start Date
September 1 2005
End Date
May 1 2016
Last Update
June 5 2017
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.