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Clinical Utility of Endothelial Dysfunction in PAD

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ClinicalTrials.gov Identifier: NCT00491751
Recruitment Status : Unknown
Verified May 2012 by Joseph A. Vita, Boston University.
Recruitment status was:  Active, not recruiting
First Posted : June 26, 2007
Last Update Posted : May 25, 2012
Information provided by (Responsible Party):
Joseph A. Vita, Boston University

Brief Summary:
This study will seek to determine whether non-invasive measures of endothelial function have utility as surrogate markers of cardiovascular risk in patients with peripheral arterial disease undergoing vascular surgery. Measurements of endothelial function will be made before and after initiation of atorvastatin, ascorbic acid, or placebo therapy during the pre-operative period. We will then examine cardiovascular events following surgery. We hypothesize that patients who have no improvement in endothelial function will have increased cardiovascular risk compared to patients with improvement in endothelial function.

Condition or disease Intervention/treatment
Peripheral Arterial Disease Drug: atorvastatin Drug: ascorbic acid Drug: Placebo

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Clinical Utility of Endothelial Dysfunction in PAD
Study Start Date : May 2004
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

Intervention Details:
    Drug: atorvastatin
    atorvastatin 40 or 80 mg/day
    Other Name: Lipitor
    Drug: ascorbic acid
    ascorbic acid 500 mg/day
    Other Name: Vitamin C
    Drug: Placebo
    matching placebo

Primary Outcome Measures :
  1. Brachial artery flow-mediated dilation [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Pulse wave velocity [ Time Frame: 30 days ]
  2. Markers of inflammation [ Time Frame: 30 days ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male and female subjects age 21-99 years old.
  2. Peripheral Arterial Disease. PAD is defined clinically and by angiography, magnetic resonance imaging, vascular ultrasound, or ankle brachial index less than 0.9.
  3. Able to provide informed consent and complete the study procedure.
  4. Patients undergoing non-emergent vascular surgery (peripheral arterial bypass, abdominal aortic aneurysm repair, carotid endarterectomy, or limb amputation) or other non-cardiac surgery.

Exclusion Criteria:

  1. Emergent or urgent surgery that must be performed sooner than one week after enrollment
  2. Unstable angina, myocardial infarction, stroke, coronary revascularization, or decompensated heart failure within 1 month of enrollment. Patients who require cardiac catheterization and surgical or percutaneous coronary revascularization prior to vascular surgery will be excluded.
  3. Clinically evident major illness of other organ systems, including cancer, end-stage renal disease, hepatic failure, or other conditions that make participation inappropriate.
  4. Women who are lactating, pregnant, or of childbearing potential and not using a reliable contraceptive method. Pregnancy will be excluded by a urine pregnancy test.
  5. Patients with liver function tests or serum creatine kinase >3 times the upper limit of normal.
  6. Patients who have received an investigational drug within 30 days of enrollment.
  7. Patients or subjects with a history of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
  8. Known occlusive atherosclerosis of the subclavian artery or upper extremity, because such disease will interfere with induction of reactive hyperemia during the brachial artery ultrasound studies.
  9. Patients will be excluded if they are taking vitamin C in a dose greater than 2 times the Recommended Daily Allowance (>120 mg/day) within 1 month of enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00491751

United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Principal Investigator: Joseph A Vita, MD Professor of Medicine

Responsible Party: Joseph A. Vita, Professor of Medicine, Boston University
ClinicalTrials.gov Identifier: NCT00491751     History of Changes
Other Study ID Numbers: H-23184
First Posted: June 26, 2007    Key Record Dates
Last Update Posted: May 25, 2012
Last Verified: May 2012

Keywords provided by Joseph A. Vita, Boston University:
nitric oxide
ascorbic acid

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Atorvastatin Calcium
Ascorbic Acid
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Protective Agents
Physiological Effects of Drugs
Growth Substances