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Warfarin and Coronary Calcification Project

NCT ID: NCT00868712

Last Updated: 2012-08-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-05-31

Study Completion Date

2010-01-31

Brief Summary

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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 Description

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Conditions

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Coronary Calcification

Keywords

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coronary calcification vitamin K dependent proteins warfarin

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Warfarin use \< 6 months

No interventions assigned to this group

2

Warfarin use 6-24 months

No interventions assigned to this group

3

Warfarin use \>24 months

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Walter Reed Army Medical Center

FED

Sponsor Role lead

Responsible Party

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Todd C. Villines

Director, Cardiovascular Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

References

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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/s00223-009-9300-4. Epub 2009 Oct 22.

Reference Type RESULT
PMID: 19847375 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/19847375

Publication abstract

Other Identifiers

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WU# 04-12020

Identifier Type: -

Identifier Source: org_study_id