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Detection of Coronary Artery Calcification: Comparison of Volumetric and Electron Beam Computed Tomography

This study has been completed.
Study NCT00001836.   Last updated on March 3, 2008.   Information provided by National Institutes of Health Clinical Center (CC)

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Descriptive Information Fields
Brief Title  Detection of Coronary Artery Calcification: Comparison of Volumetric and Electron Beam Computed Tomography
Official Title  Detection of Coronary Artery Calcification: Comparison of Volumetric and Electron Beam Computed Tomography
Brief Summary

Electron beam computed tomography (EBCT) has been regarded as the state-of-the-art investigation for detecting and quantitating coronary artery calcification. However, EBCT is expensive, and the asymmetric gantry geometry makes it less useful for routine scanning; thus, EBCT is not readily available to the general population. Recent reports have shown that "volumetric" (also known as "helical" or "spiral") scanners, which are much more commonly available than EBCT, can detect coronary artery calcifications. Updated software available to the NIH which will allow for EKG gating of volumetric scans should improve the quality of the images, and thus improve the ability to accurately quantitate coronary calcification by volumetric scanners. We would like to compare the results of volumetric scans with that of standard EBCT in order to characterize similarities and differences between the two scanning techniques. We propose to obtain EBCT and volumetric CT scans of the coronary arteries in a group of patients with known or suspected coronary artery disease and to calculate the calcium score by each method. Our primary analysis will be a comparison of the sensitivities of the two methods.

Detailed Description

Electron beam computed tomography (EBCT) has been regarded as the state-of-the-art investigation for detecting and quantitating coronary artery calcification. However, EBCT is expensive, and the asymmetric gantry geometry makes it less useful for routine scanning; thus, EBCT is not readily available to the general population. Recent reports have shown that "volumetric" (also known as "helical" or "spiral") scanners, which are much more commonly available than EBCT, can detect coronary artery calcifications. Updated software available to the NIH which will allow for EKG gating of volumetric scans should improve the quality of the images, and thus improve the ability to accurately quantitate coronary calcification by volumetric scanners. We would like to compare the results of volumetric scans with that of standard EBCT in order to characterize similarities and differences between the two scanning techniques. We propose to obtain EBCT and volumetric CT scans of the coronary arteries in a group of patients with known or suspected coronary artery calcification, including subjects of sufficiently advanced age, and to calculate the calcium score by each method. Our primary analysis will be a comparison of the sensitivities of the two methods.

Study Phase
Study Type  Observational
Study Design 
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Coronary Disease
Intervention 
MEDLINE PMIDs 1410350,   8284380,   7480756
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  213
Start Date  October 1998
Completion Date November 2001
Eligibility Criteria 

Must have known or suspected coronary artery calcification, including subjects of age equal to or greater than 55 years (men), or 65 years (women).

Must be at increased risk for CAD. (Chronic hypertension greater than 140/90, cholesterolemia greater than 130 mg/dl, active cigarette smoker, or diabetes mellitus.)

Must be 18 years of age or older.

Females must not be pregnant or considering pregnancy and must not be lactating.

Must not have any surgical devices which may interfere with imaging: heart valves, pacemakers, sternal wire sutures, epicardial pacer leads, metallic coronary stents.

Must not have tachycardia greater than 90 bpm at time of scanning, or other fast or irregular rhythm.

Must not be obese. Patients weighing more than 300 pounds will be excluded since this is the table weight limit for the EBCT scanner.

Must be able to suspend respiration for 28 seconds at time of scanning.

Must be able to give informed consent.

Gender Both
Ages
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00001836
Organization ID 990001
Secondary IDs †† 99-CC-0001
Study Sponsor  National Institutes of Health Clinical Center (CC)
Collaborators ††
Investigators 
Information Provided By National Institutes of Health Clinical Center (CC)
Verification Date November 2001
First Received Date  November 3, 1999
Last Updated Date March 3, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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