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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00770679
First received: October 9, 2008
Last updated: August 3, 2009
Last verified: August 2009
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Effects of Statins on Lower Extremity Arterial Function Assessed by Magnetic Resonance Imaging

Resource links provided by NLM:


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 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: lipitor
    80 mg everyday (QD) for 3 weeks
    Other Name: atorvastatin
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Harry Silber, MD, JHU
ClinicalTrials.gov Identifier: NCT00770679     History of Changes
Other Study ID Numbers: NA00002253
Study First Received: October 9, 2008
Last Updated: August 3, 2009
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 24, 2014