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

This study is currently recruiting participants.

Verified by Johns Hopkins University, October 2008

First Received: October 9, 2008 No Changes Posted

Sponsored by:	Johns Hopkins University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00770679

Purpose

Cholesterol-lowering drugs called statins improve the functioning of the endothelium, and help prevent heart disease. We 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. You are being asked to participate in a study using MRI to test whether a 3-week course of statins improves the endothelium of legs more than it improves the endothelium of arms.

Adults with type 2 diabetes may join.

Condition	Intervention
Diabetes	Drug: lipitor

MedlinePlus related topics: Diabetes MRI Scans Statins

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment
Official Title:	Effects of Statins on Lower Extremity Arterial Function Assessed by Magnetic Resonance Imaging

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

Femoral hyperemic shear rate [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	July 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Intervention Details:

80 mg everyday (QD) for 3 weeks

Detailed Description:

Correct

Eligibility

Ages Eligible for Study:	40 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 40-90
Male or female
Type 2 diabetes

Exclusion Criteria:

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770679

Locations

United States, Maryland
Harry SIlber, MD	Recruiting
Baltimore, Maryland, United States, 21224
Contact: Melanie Herr, RN 410-550-5127 mherr@jhmi.edu

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator:

Harry Silber, MD

JHU

More Information

No publications provided

Responsible Party:	JHU ( Harry Silber, MD )
Study ID Numbers:	NA00002253
Study First Received:	October 9, 2008
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00770679 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Diabetes Mellitus
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Atorvastatin

ClinicalTrials.gov processed this record on May 06, 2009