Coronary Calcification Progression Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006526
Recruitment Status : Completed
First Posted : November 28, 2000
Last Update Posted : March 16, 2016
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

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.

Condition or disease
Cardiovascular Diseases Coronary Disease Heart Diseases

Detailed Description:


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.


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.

Study Type : Observational
Study Start Date : July 1999
Actual Study Completion Date : May 2003

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
No eligibility criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006526

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
OverallOfficial: John Crouse Wake Forest University Identifier: NCT00006526     History of Changes
Other Study ID Numbers: 951
R01HL063264 ( U.S. NIH Grant/Contract )
First Posted: November 28, 2000    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: August 2004

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Vascular Diseases
Arterial Occlusive Diseases