Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258999
Status:
COMPLETED
Last Update Posted:
2015-10-05
First Post:
2005-11-23
Brief Title:
Predictor of Advanced Sub-Clinical Atherosclerosis PASA Study
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Predictor of Advanced Sub-Clinical Atherosclerosis PASA Study
Status:
COMPLETED
Status Verified Date:
2007-12
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:
The study will evaluate the clinical utilization of skin Cholesterol SC for cardiovascular risk assessment in asymptomatic individuals at low intermediate and high risk based on Framingham global risk estimates
Preliminary studies have suggested that SC is an easy to measure noninvasive marker of cardiovascular risk This study is intended to provide further data in support of broader clearance by the Food and Drug Administration for the use of SC as a tool to identify asymptomatic patients at increased risk of cardiovascular disease Currently SC testing is cleared for use as part of risk assessment in subject suspected of having significant multi-vessel disease
The current study data will be used to support the use of SC testing as part of cardiovascular risk assessment in subjects without suspected coronary artery disease CAD
Preliminary studies have suggested that SC is an easy to measure noninvasive marker of cardiovascular risk This study is intended to provide further data in support of broader clearance by the Food and Drug Administration for the use of SC as a tool to identify asymptomatic patients at increased risk of cardiovascular disease Currently SC testing is cleared for use as part of risk assessment in subject suspected of having significant multi-vessel disease
The current study data will be used to support the use of SC testing as part of cardiovascular risk assessment in subjects without suspected coronary artery disease CAD
Detailed Description:
The primary objective of the study will be to determine the relationship between skin cholesterol levels and carotid artery intima-media thickness CIMT a surrogate marker for atherosclerotic burden used as the gold standard comparator
Secondary objectives of the study will be to compare the skin cholesterol levels with other markers of CAD as HDL cholesterol Apo B hsCRP and lipoprotein-association phospholipase A2
Another objective is to determine the relationship between skin cholesterol levels and the presence of carotid plaques detected by ultrasound
Secondary objectives of the study will be to compare the skin cholesterol levels with other markers of CAD as HDL cholesterol Apo B hsCRP and lipoprotein-association phospholipase A2
Another objective is to determine the relationship between skin cholesterol levels and the presence of carotid plaques detected by ultrasound
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None