Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006526
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2000-11-28
Brief Title:
Coronary Calcification Progression Study
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2004-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL063264 | NIH | None | httpsreporternihgovquickSearchR01HL063264 |