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Coronary Calcification Progression Study

This study has been completed.

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00006526
  Purpose

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
Cardiovascular Diseases
Coronary Disease
Heart Diseases

MedlinePlus related topics:   Heart Diseases   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Natural History, Case Control

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date:   July 1999
Estimated Study Completion Date:   May 2003

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.

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

Criteria

No eligibility criteria

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006526

Sponsors and Collaborators

Investigators
Investigator:     John Crouse     Wake Forest University    
  More Information


Study ID Numbers:   951
First Received:   November 28, 2000
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00006526
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Disease Progression
Ischemia

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 03, 2008




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