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

Primary Purpose

Coronary Disease

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Coronary Disease focused on measuring Coronary Artery Disease, EBCT, Volumetric Scan, Coronary Artery Calcium, Prospective Gating

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Warren G. Magnuson Clinical Center (CC)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institutes of Health Clinical Center (CC)
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1. Study Identification

Unique Protocol Identification Number
NCT00001836
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
Study Type
Observational

2. Study Status

Record Verification Date
November 2001
Overall Recruitment Status
Completed
Study Start Date
October 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institutes of Health Clinical Center (CC)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
Coronary Artery Disease, EBCT, Volumetric Scan, Coronary Artery Calcium, Prospective Gating

7. Study Design

Enrollment
213 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Warren G. Magnuson Clinical Center (CC)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1410350
Citation
Breen JF, Sheedy PF 2nd, Schwartz RS, Stanson AW, Kaufmann RB, Moll PP, Rumberger JA. Coronary artery calcification detected with ultrafast CT as an indication of coronary artery disease. Radiology. 1992 Nov;185(2):435-9. doi: 10.1148/radiology.185.2.1410350.
Results Reference
background
PubMed Identifier
8284380
Citation
Kaufmann RB, Sheedy PF 2nd, Breen JF, Kelzenberg JR, Kruger BL, Schwartz RS, Moll PP. Detection of heart calcification with electron beam CT: interobserver and intraobserver reliability for scoring quantification. Radiology. 1994 Feb;190(2):347-52. doi: 10.1148/radiology.190.2.8284380.
Results Reference
background
PubMed Identifier
7480756
Citation
Shemesh J, Apter S, Rozenman J, Lusky A, Rath S, Itzchak Y, Motro M. Calcification of coronary arteries: detection and quantification with double-helix CT. Radiology. 1995 Dec;197(3):779-83. doi: 10.1148/radiology.197.3.7480756.
Results Reference
background

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

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