Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00388843
Status:
WITHDRAWN
Last Update Posted:
2015-08-24
First Post:
2006-10-16
Brief Title:
Carotid Plaque Regression With Statin Treatment Assessed by High Field Magnetic Resonance Imaging MRI
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
Short Term Carotid Plaque Regression in Patients With Atherosclerotic Disease Taking Statins Assessed by High Field MRI
Status:
WITHDRAWN
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI has left institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to determine if short term 6 months treatment with statins to lower low-density lipoprotein LDL in vascular disease patients with carotid plaque will be associated with a measurable reduction in carotid plaque volume using 3 Tesla MRI The researchers will correlate the change in plaque volume to degree of LDL lowering The researchers will also study if brief treatment will lead to change in plaque composition The researchers will compare the change in plaque volume measured by 3T MRI with plaque burden measured by ultrasound
Detailed Description:
Atherosclerotic vascular disease is the leading cause of death in the United States Atherosclerosis develops with increasing plaque burden and eccentric arterial wall expansion or remodeling later leading to luminal obstruction More than 90 of patients with CAD have carotid plaques Statins have been shown to cause plaque regression in the carotid and coronary arteries However there is ongoing controversy about how low the target LDL should be in atherosclerotic patients The benefits of aggressive LDL lowering with higher statin doses are counterbalanced by the potential for liver and muscle toxicity High field 3 Tesla MRI is a promising new modality for measuring plaque volume with high spatial resolution It is not clear whether increasing statin dose will lead to plaque volume reduction in the short-term 6 months that can be measured by this new modality
The primary aim of the study is to determine if LDL lowering using statins in vascular disease patients with carotid plaque will be associated with measurable reduction in carotid plaque volume in the short term 6 months using 3T MRI
The four secondary aims of the study are as follows
To compare the short term carotid plaque volume change using high field MRI in vascular disease patients whose statin dose was increased dose increased versus those whose statin dose was maintained dose maintained
To determine if increasing statin dose in patients with carotid plaque will lead to measurable change in carotid plaque composition in the short term 6 months using 3T MRI
To compare the carotid plaque volume change using 3T MRI with change in plaque burden score using carotid ultrasound
To determine the relationship between change in plaque volume with change in lipid levels total cholesterol LDL HDL and change in inflammatory markers cytokines high sensitivity CRP
The study is significant because it will provide insight into optimal statin treatment for atherosclerotic disease It will also test a new modality for measurement of plaque burden A reliable and sensitive test with high spatial resolution that accurately measures change in plaque volume will be helpful in assessing response to treatment and as a tool for future clinical trials in assessing efficacy of new treatment modalities that may reduce the need for expensive long term studies that rely on clinical events for outcome measurement
The primary aim of the study is to determine if LDL lowering using statins in vascular disease patients with carotid plaque will be associated with measurable reduction in carotid plaque volume in the short term 6 months using 3T MRI
The four secondary aims of the study are as follows
To compare the short term carotid plaque volume change using high field MRI in vascular disease patients whose statin dose was increased dose increased versus those whose statin dose was maintained dose maintained
To determine if increasing statin dose in patients with carotid plaque will lead to measurable change in carotid plaque composition in the short term 6 months using 3T MRI
To compare the carotid plaque volume change using 3T MRI with change in plaque burden score using carotid ultrasound
To determine the relationship between change in plaque volume with change in lipid levels total cholesterol LDL HDL and change in inflammatory markers cytokines high sensitivity CRP
The study is significant because it will provide insight into optimal statin treatment for atherosclerotic disease It will also test a new modality for measurement of plaque burden A reliable and sensitive test with high spatial resolution that accurately measures change in plaque volume will be helpful in assessing response to treatment and as a tool for future clinical trials in assessing efficacy of new treatment modalities that may reduce the need for expensive long term studies that rely on clinical events for outcome measurement
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