Carotid Plaque Regression With Statin Treatment Assessed by High Field Magnetic Resonance Imaging (MRI)

NCT00388843 | Withdrawn

• 1 other identifier: PRO00002285
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Atherosclerosis

Keywords

carotid atherosclerosis; magnetic resonance imaging; atherosclerosis; ultrasound; inflammation; statins; vulnerable plaque; stroke

Outcome Measures

Primary Outcomes (1)

• Change in carotid artery plaque volume assessed by carotid MRI at 6 months

  6 months

Secondary Outcomes (4)

• Change in carotid intima media thickness on ultrasound at 6 months

  6 months

• Change in plaque composition by carotid MRI at 6 months

  6 months

• Change in inflammatory markers at 6 months

  6 months

• Change in regional wall shear stress in the carotid artery

  6 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin/Froedtert Memorial and Lutheran Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Related Links

• Medical College of Wisconsin site

MeSH Terms

Conditions

Carotid Artery Diseases; Atherosclerosis; Inflammation; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Raymond Migrino, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 16, 2006
• First Posted: October 17, 2006
• Study Start: August 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: August 24, 2015

Record last verified: 2015-08

Locations

US (1)