Warfarin and Coronary Calcification Project

Coronary Calcification Clinical Trial

— WACC  

Official title:

Warfarin and Coronary Calcification Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00868712
• Other study ID #: WU# 04-12020
• Status: Completed
• Phase: N/A
• First received: March 24, 2009
• Last updated: August 23, 2012
• Start date: May 2004
• Est. completion date: January 2010

Study information

• Verified date: August 2012
• Source: Walter Reed Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years of age or older

• Patients referred to begin or already treated with warfarin anticoagulation therapy.

Exclusion Criteria:

• Known prior myocardial infarction or coronary heart disease

• History of advanced chronic kidney disease manifested by serum creatinine>2 or calculated glomerular filtration rate (GFR)<30

• History of hyperparathyroidism

• Current hypercalcemia

• Current hyperphosphatemia

• Uncertain duration of warfarin therapy

• Lack of records documenting international normalized ratio (INR) during therapy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Calcinosis
• Coronary Calcification

Locations

Country	Name	City	State
United States	Walter Reed Army Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed Army Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Villines TC, O'Malley PG, Feuerstein IM, Thomas S, Taylor AJ. Does prolonged warfarin exposure potentiate coronary calcification in humans? Results of the warfarin and coronary calcification study. Calcif Tissue Int. 2009 Dec;85(6):494-500. doi: 10.1007/s — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Agatston score is calculated using a non-contrast computed tomography (CT) scan to measure for the presence and severity of coronary artery disease through identification of calcification in the coronary arteries. Scores can range from 0 to several thousands. The measure is without units. Score categories are as follows: 0 = no coronary disease; 1-100 = low amount of coronary artery disease; 101-400 = moderately elevated score / moderate coronary artery disease; 401-1000 = severely elevated score; >1000 very severely elevated score. Higher Agatston scores corelate with more coronary artery disease and predict a higher risk of coronary heart disease events and mortality.	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.	No
Secondary	International Normalized Ratio	The International Normalized Ratio (INR) is a standardized lab value that measures the intensity of anticogulation using warfarin. It is used to monitor patients taking warfarin.	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.	No

External Links

•   Publication abstract