Effects of Statins on Lower Extremity Arterial Function Assessed by Magnetic Resonance Imaging

NCT00770679 | Terminated Results

• 1 other identifier: NA00002253
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Cholesterol-lowering drugs called statins improve the functioning of the endothelium, and help prevent heart disease. The investigators are testing whether statins improve endothelial function more in the arteries that have worse endothelium to begin with. One of the functions of the endothelium is to help control how blood vessels dilate (expand) or contract (narrow) in different situations. This affects how blood flows through those vessels. Magnetic resonance imaging (MRI) can be used to evaluate endothelial function in the arms and legs noninvasively.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (3)

• Mean Change in Low Density Lipoprotein (LDL)

  Serum LDL, mg/dL (baseline LDL-follow-up LDL)

  Change from baseline to follow-up, up to 5 weeks

• Change in Endothelial Function as Measured on MRI in the Arms

  chance from baseline to end of study, up to 5 weeks

• Change in Endothelial Function as Measured on MRI in the Legs

  chance from baseline to end of study, up to 5 weeks

Study Arms (1)

High-Dose Statin

EXPERIMENTAL

80 mg atorvastatin daily for 3 weeks

Drug: lipitor

Interventions

lipitor DRUG

80 mg everyday (QD) for 3 weeks

Also known as: atorvastatin

High-Dose Statin

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-90
• Male or female
• Type 2 diabetes

You may not qualify if:

• Known pregnancy or nursing.
• Females of child bearing potential must have been surgically sterilized or be post menopausal.
• Smoking
• Known vascular disease
• Inability to complete MRI scan
• Symptoms of claudication
• Use of a nitrate medicine
• Use of any cholesterol-lowering agent
• LDL \< 70
• Acute illness
• Liver disease
• Contraindication to getting an MRI scan (i.e. electronic implant, shrapnel, cerebral aneurysm clip, welding history).

Sponsors & Collaborators

• Johns Hopkins University: lead
• Pfizer: collaborator

Study Sites (1)

Harry SIlber, MD

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Harry Silber, M.D., Ph.D. Assistant Professor of Medicine, Division of Cardiology
• Organization: Johns Hopkins University School of Medicine

hsilber@jhmi.edu

4105505717

Study Officials

• Harry Silber, MD

  JHU

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2008
• First Posted: October 10, 2008
• Study Start: June 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 13, 2017
• Results First Posted: September 13, 2017

Record last verified: 2017-08

Locations

US (1)