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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001836
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: November 2001
  Purpose

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.


Condition
Coronary Disease

Study Type: Observational
Official Title: Detection of Coronary Artery Calcification: Comparison of Volumetric and Electron Beam Computed Tomography

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 213
Study Start Date: October 1998
Estimated Study Completion Date: November 2001
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00001836

Locations
United States, Maryland
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001836     History of Changes
Other Study ID Numbers: 990001, 99-CC-0001
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Coronary Artery Disease
EBCT
Volumetric Scan
Coronary Artery Calcium
Prospective Gating

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Calcinosis
Arteriosclerosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Calcium Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014