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

This study has been terminated.
(Delayed recruitment, funding exhausted)
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00770679
First received: October 9, 2008
Last updated: August 14, 2017
Last verified: August 2017
  Purpose
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.

Condition Intervention
Diabetes Drug: lipitor

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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:
  • Mean Change in Low Density Lipoprotein (LDL) [ Time Frame: Change from baseline to follow-up, up to 5 weeks ]
    Serum LDL, mg/dL (baseline LDL-follow-up LDL)

  • Change in Endothelial Function as Measured on MRI in the Arms [ Time Frame: chance from baseline to end of study, up to 5 weeks ]
  • Change in Endothelial Function as Measured on MRI in the Legs [ Time Frame: chance from baseline to end of study, up to 5 weeks ]

Enrollment: 16
Actual Study Start Date: June 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High-Dose Statin
80 mg atorvastatin daily for 3 weeks
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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Pfizer
Investigators
Principal Investigator: Harry Silber, MD JHU
  More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00770679     History of Changes
Other Study ID Numbers: NA00002253
Study First Received: October 9, 2008
Results First Received: July 17, 2017
Last Updated: August 14, 2017

Additional relevant MeSH terms:
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 19, 2017