Carotid AtherosclerosisNCT00388843
Carotid Plaque Regression With Statin Treatment Assessed by High Field Magnetic Resonance Imaging (MRI)
An observational study of Carotid Atherosclerosis, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Carotid Atherosclerosis
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Feb 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with coronary artery disease or suspected cerebrovascular accident who have carotid plaque (> 1.1 mm) and whose statin dose has been increased to moderate or high dose (increased statin dose) or maintained (maintained statin dose).
Who may be able to join
- Adult (> 21 years old) patients.
- Diagnosed with coronary artery disease or suspected cerebrovascular accident.
- For dose increased subjects, patients whose statin dose or LDL lowering therapy is doubled or increased from standard dose to high dose (see table).
- For dose maintained subjects, patients whose statin dose or LDL lowering therapy is maintained at standard dose (see table).
- Standard Dose (reported LDL↓ < 40% from literature)
- Drug Daily Dose/s: (md/day)
Show all 18Show fewer
- atorvastatin 10
- simvastatin 5, 10, 20
- pravastatin 10, 20, 40, 80
- fluvastatin 20, 40, 80
- lovastatin 10, 20, 40
- High Dose (reported LDL↓ > 40% from literature)
- Drug Daily Dose/s (mg/day)
- atorvastatin 40, 80
- simvastatin 40, 80
- lovastatin 80
- rosuvastatin 5, 10, 20, 40
- Addition of non-statin lipid transfer (tx) (e.g., ezetimibe, fibrate, niacin) to standard statin dose
Who cannot join
- severe claustrophobia causing inability to undergo MRI implanted ferromagnetic materials (pacemakers, defibrillators, TENS units, aneurysm clips, etc.) that are not suitable for MRI in the clinical setting
- patients anticipated to undergo carotid stenting or surgery in next 6 months
- patients unable to lie flat for 1 hour
- patients requiring supplemental oxygen
- pregnant women
- patients who could not be followed up for 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin/Froedtert Memorial and Lutheran Hospital
Milwaukee, Wisconsin, 53226
About this study
Official title: Short Term Carotid Plaque Regression in Patients With Atherosclerotic Disease Taking Statins Assessed by High Field MRI
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.
Read the 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.
- Conditions
- Carotid Atherosclerosis
- Keywords
- carotid atherosclerosis, magnetic resonance imaging, atherosclerosis, ultrasound, inflammation, statins, vulnerable plaque, stroke
- Medical subject headings
- Carotid Artery Diseases, Atherosclerosis, Inflammation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dose Increased | Patients presenting with symptoms of coronary artery disease or stroke/suspected stroke, with carotid plaque > 1.1 mm, and whose statin dose is increased to moderate to high dose by their clinicians. | |
| Dose Maintained | Patients presenting with symptoms due to coronary artery disease or stroke/suspected stroke, with carotid plaque > 1.1 mm, on no statins or whose statin dose was unchanged by their clinicians. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in carotid artery plaque volume assessed by carotid MRI at 6 months
Measured: 6 months
Secondary outcomes (4)
Change in carotid intima media thickness on ultrasound at 6 months
Measured: 6 months
Change in plaque composition by carotid MRI at 6 months
Measured: 6 months
Change in inflammatory markers at 6 months
Measured: 6 months
Change in regional wall shear stress in the carotid artery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2006 (estimated)
- Study startAug 2006
- Primary completionFeb 2009
- Study completionFeb 2009
Why it stopped: PI has left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Investigators
- Raymond Migrino, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00388843
- Sponsor's protocol ID
- PRO00002285
- Status last verified
- Aug 2015
- First submitted
- 16 Oct 2006
- Last updated
- 24 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Carotid Plaque Regression in Patients With Atherosclerotic Disease Taking Statins Assessed by High Field MRI
- ClinicalTrials.gov ID
- NCT00388843
- Acronym / sponsor ID
- PRO00002285
- Conditions
- Carotid Atherosclerosis
- Keywords
- carotid atherosclerosis, magnetic resonance imaging, atherosclerosis, ultrasound, inflammation, statins, vulnerable plaque, stroke
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI has left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 17 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Increased | – | –Patients presenting with symptoms of coronary artery disease or stroke/suspected stroke, with carotid plaque > 1.1 mm, and whose statin dose is increased to moderate to high dose by their clinicians. |
| Dose Maintained | – | –Patients presenting with symptoms due to coronary artery disease or stroke/suspected stroke, with carotid plaque > 1.1 mm, on no statins or whose statin dose was unchanged by their clinicians. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with coronary artery disease or suspected cerebrovascular accident who have carotid plaque (> 1.1 mm) and whose statin dose has been increased to moderate or high dose (increased statin dose) or maintained (maintained statin dose).
Key inclusion criteria (18 listed)
- Adult (> 21 years old) patients.
- Diagnosed with coronary artery disease or suspected cerebrovascular accident.
- For dose increased subjects, patients whose statin dose or LDL lowering therapy is doubled or increased from standard dose to high dose (see table).
- For dose maintained subjects, patients whose statin dose or LDL lowering therapy is maintained at standard dose (see table).
- Standard Dose (reported LDL↓ < 40% from literature)
Key exclusion criteria (6 listed)
- severe claustrophobia causing inability to undergo MRI implanted ferromagnetic materials (pacemakers, defibrillators, TENS units, aneurysm clips, etc.) that are not suitable for MRI in the clinical setting
- patients anticipated to undergo carotid stenting or surgery in next 6 months
- patients unable to lie flat for 1 hour
- patients requiring supplemental oxygen
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in carotid artery plaque volume assessed by carotid MRI at 6 months
Time frame: 6 months
4 secondary outcomes
Change in carotid intima media thickness on ultrasound at 6 months
Time frame: 6 months
Change in plaque composition by carotid MRI at 6 months
Time frame: 6 months
Change in inflammatory markers at 6 months
Time frame: 6 months
Change in regional wall shear stress in the carotid artery
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2015.
- Medical College of Wisconsin siteLink provided by the sponsor.
Related trials for Carotid Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Recruiting
Predicting High-Risk Carotid Plaque: Integrating radioMics and biomEchanics
Carotid Artery, Carotid Arteriosclerosis
Not yet recruiting
Effects of Rosa Roxburghii Tratt Freeze-Dried Powder on Carotid Atherosclerotic Plaques: A Real-World Study
Carotid Artery Plaques, Atherosclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond Migrino, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Atherosclerosis, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in carotid artery plaque volume assessed by carotid MRI at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2015.