Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00245284
Status:
COMPLETED
Last Update Posted:
2006-06-06
First Post:
2005-10-26
Brief Title:
Predictor of Advanced Subclinical Atherosclerosis
Sponsor:
PreMD
Organization:
PreMD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2006-06
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:
Evaluation of skin cholesterol for cardiovascular risk assessment in asymptomatic individuals at low intermediate or high risk based on Framingham Global Risk estimates Carotid intima-media thickness IMT a surrogate marker for atherosclerotic burden that independently predicts the occurrence of heart attack and stroke will be the gold standard comparator
Hypothesis Skin cholesterol as measured by two non-invasive tests correlates with CAD as measured by CIMT in this population
Hypothesis Skin cholesterol as measured by two non-invasive tests correlates with CAD as measured by CIMT in this population
Detailed Description:
This study will enroll 600 asymptomatic subjects at low 6 intermediate 6-20 or high 20 10-year Framingham global cardiovascular risk in approximately equal proportions
Subjects will be enrolled from each of the three risk levels at each study site 6 total in the US Subjects will be enrolled in a consecutive manner until there are 200 subjects from each risk level We will track the number of subjects from each risk stratum We will also ensure adequate representation of women at least 33 and African Americans at least 25in the study
We will test the subjects with 2 non-invasive skin cholesterol tests and will take a sample of blood that will be tested for serum cholesterol values and other markers of CAD Subjects will also undego a carotid IMT scan
The primary objective of the study is to see if skin cholesterol correlates with CAD as measured by CIMT
Subjects will be enrolled from each of the three risk levels at each study site 6 total in the US Subjects will be enrolled in a consecutive manner until there are 200 subjects from each risk level We will track the number of subjects from each risk stratum We will also ensure adequate representation of women at least 33 and African Americans at least 25in the study
We will test the subjects with 2 non-invasive skin cholesterol tests and will take a sample of blood that will be tested for serum cholesterol values and other markers of CAD Subjects will also undego a carotid IMT scan
The primary objective of the study is to see if skin cholesterol correlates with CAD as measured by CIMT
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