Coronary CalcificationWACCNCT00868712
Warfarin and Coronary Calcification Project
An observational study of Coronary Calcification, run by Walter Reed Army Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Calcification
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Jan 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients without known coronary heart disease, disorders of calcium metabolism or chronic kidney disease aged > 18 years who are referred to take or currently taking warfarin and are followed in the Anticoagulation Management Clinic at Walter Reed Army Medical Center (WRAMC).
Who may be able to join
- Age 18 years of age or older
- Patients referred to begin or already treated with warfarin anticoagulation therapy.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
About this study
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.
- Conditions
- Coronary Calcification
- Keywords
- coronary calcification, vitamin K dependent proteins, warfarin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Warfarin use < 6 months | |
| 2 | Warfarin use 6-24 months | |
| 3 | Warfarin use >24 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (1)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startMay 2004
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary CalcificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Todd C. Villines, Walter Reed Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868712
- Sponsor's protocol ID
- WU# 04-12020
- Acronym
- WACC
- Status last verified
- Aug 2012
- First submitted
- 24 Mar 2009
- Last updated
- 24 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 19847375
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Warfarin and Coronary Calcification Project
- ClinicalTrials.gov ID
- NCT00868712
- Acronym / sponsor ID
- WACC / WU# 04-12020
- Conditions
- Coronary Calcification
- Keywords
- coronary calcification, vitamin K dependent proteins, warfarin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- Study start
- May 2004
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 25 Mar 2009 (estimated)
- Results
- Posted 24 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Warfarin use < 6 months |
| 2 | – | –Warfarin use 6-24 months |
| 3 | – | –Warfarin use >24 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients without known coronary heart disease, disorders of calcium metabolism or chronic kidney disease aged > 18 years who are referred to take or currently taking warfarin and are followed in the Anticoagulation Management Clinic at Walter Reed Army Medical Center (WRAMC).
Key inclusion criteria (2 listed)
- Age 18 years of age or older
- Patients referred to begin or already treated with warfarin anticoagulation therapy.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
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.
1 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19847375Villines 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.
- Publication abstractLink provided by the sponsor.
Related trials for Coronary Calcification
Not yet recruitingObservational study
Tissue Validation of Mammographic Breast Arterial Calcification in Mastectomy Specimens
Breast Cancer, Vascular Calcification
Not yet recruitingObservational study
SoniCrackerTM Single-use Intracoronary Shockwave Catheter
Primary Coronary Artery Calcification
Active, not recruiting
Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease (FRACTURE)
Coronary Artery Disease, Coronary Artery Calcification
Active, not recruiting
Intravascular Lithotripsy With or Without Rotational Atherectomy for Coronary Calcified Nodule Treatment
Coronary Artery Disease, Coronary Calcification
RecruitingObservational study
Cardiovascular Risk Assessment and Coronary Calcium Score in Thai MASLD Patients
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Cardiovascular Disease (CVD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Calcification, run by Walter Reed Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00868712, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2012; AzTrials last refreshed its copy on 30 Oct 2026.