NCT00001836

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
213

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 1998

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1998

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2001

Completed
Last Updated

March 4, 2008

Status Verified

November 1, 2001

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

Coronary Artery DiseaseEBCTVolumetric ScanCoronary Artery CalciumProspective Gating

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Warren G. Magnuson Clinical Center (CC)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 1410350BACKGROUND
  • 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.

    PMID: 8284380BACKGROUND
  • 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.

    PMID: 7480756BACKGROUND

MeSH Terms

Conditions

Coronary DiseaseCoronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

October 1, 1998

Study Completion

November 1, 2001

Last Updated

March 4, 2008

Record last verified: 2001-11

Locations