Clinical Trial: Warfarin and Coronary Calcification Project
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Warfarin and Coronary Calcification Project
Brief Summary: The purpose of the study is to assess whether the use of warfarin, a commonly used anticoagulation drug, is associated with increased amounts of coronary artery calcification. Studies in animals and preliminary but small retrospective studies in humans have suggested a possible link to increased tissue calcification with use of this drug. The researchers will investigate this by assessing the amount of calcification seen in the coronary arteries using a specialized computed tomography (CT) scan (electron-beam CT) and assessing to see if the amount is influenced by the amount of time a patient has been taking warfarin. The researchers will exclude patients with known coronary artery disease, chronic kidney disease or hyperparathyroidism.
Detailed Summary:
Sponsor: Walter Reed Army Medical Center
Current Primary Outcome: Coronary Calcification (Presence and Degree as Measured by Agatston Score) Attributed to Duration of Warfarin Use in Months After Controlling for Standard Cardiovascular Risk Factors to Include the Framingham Risk Score [ Time Frame: EBCT scan is done at time of enrollment of patient into 1 of 3 groups based on warfarin use duration: <6 months; 6-24 months; >24 mos. ]
Original Primary Outcome: Coronary Calcification (Presence and Degree as Measured by Agatston Score) Attributed to Duration of Warfarin Use in Months After Controlling for Standard Cardiovascular Risk Factors to Include the Framingham Risk Score [ Time Frame: EBCT scan is done at time of enrollment of patient into 1 of 3 groups based on warfarin use duration: <6 months; 6-24 months; >24 mos. ]
Current Secondary Outcome: International Normalized Ratio [ Time Frame: EBCT scan is done at time of enrollment of patient into 1 of 3 groups based on warfarin use duration: <6 months; 6-24 months; >24 mos. ]
Original Secondary Outcome: Prevalence and severity of coronary calcification related to intensity of anticoagulation, measured as the mean INR during treatment multiplied by the duration of warfarin use [ Time Frame: EBCT scan is done at time of enrollment of patient into 1 of 3 groups based on warfarin use duration: <6 months; 6-24 months; >24 mos. ]
Information By: Walter Reed Army Medical Center
Dates:
Date Received: March 24, 2009
Date Started: May 2004
Date Completion:
Last Updated: August 23, 2012
Last Verified: August 2012