Coronary Calcification Progression Study
Primary Purpose
Cardiovascular Diseases, Coronary Disease, Heart Diseases
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00006526
First Posted
November 28, 2000
Last Updated
March 15, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00006526
Brief Title
Coronary Calcification Progression Study
Study Type
Observational
2. Study Status
Record Verification Date
August 2004
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To investigate use of Fast Gated Helical Computed Tomography (FGHCT) measures of coronary artery calcium (CAC), FGHCT-CAC, for discrimination of coronary artery disease (CAD) and to quantify progression of coronary artery calcium over time.
Detailed Description
BACKGROUND:
While advances have been made in control of some coronary heart disease (CHD) risk factors, especially smoking and high dietary fat intake, much of the decline in age-adjusted CHD mortality rates has been due to medical treatment and procedural interventions for overt CHD as well as hypertension and hypercholesterolemia. In this context, the availability of an inexpensive, sensitive and specific method for noninvasive detection of both early coronary atherosclerosis and asymptomatic but advanced CHD could allow beneficial treatments to be targeted at many high-risk individuals. The study was designed to determine whether fast-gated helical computed tomography (FGHCT), a more advanced and readily-available variant of a technique (EBCT) that has not achieved its full promise, could play such a role.
DESIGN NARRATIVE:
Dr. Crouse and his colleagues augmented ongoing case-control studies, HL35333, "Carotid Atherosclerosis Progression Study" and HL59503, "Vascular Disease, Structure and Function". HL35333 comprises 280 symptomatic individuals > 45 years equally divided between men and women, half with and half without angiographically defined coronary artery disease evaluated for risk factors and extracranial carotid intimal-medial thickness (ECIMT, with B-mode ultrasound) at baseline and yearly for three years. The grant has quantified the associations of coronary artery disease and coronary artery disease risk factors for ECIMT and its progression. HL59503 quantifies flow-mediated brachial artery reactivity (FM-BAR) in this cohort. Literature review suggests that while ECIMT predicts coronary artery disease status in clinical samples it does less well in asymptomatic samples; longitudinal data (CLAS study) suggest that progression of ECIMT best predicted incident coronary artery disease, and Electron Beam Computed Tomography (EBCT) quantification of Coronary Artery Calcium (CAC) likely has even greater discriminatory power for coronary artery disease than ECIMT. However, EBCT has limited accessibility.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Coronary Disease, Heart Diseases
7. Study Design
10. Eligibility
Sex
All
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Crouse
Organizational Affiliation
Wake Forest University
12. IPD Sharing Statement
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Coronary Calcification Progression Study
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