Clinical Utility of Endothelial Dysfunction in PAD

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Boston University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Joseph A. Vita, Boston University
ClinicalTrials.gov Identifier:
NCT00491751
First received: June 22, 2007
Last updated: May 23, 2012
Last verified: May 2012
  Purpose

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 Intervention
Peripheral Arterial Disease
Drug: atorvastatin
Drug: ascorbic acid
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Clinical Utility of Endothelial Dysfunction in PAD

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Brachial artery flow-mediated dilation [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pulse wave velocity [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Markers of inflammation [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: May 2004
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00491751

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

No publications provided

Responsible Party: Joseph A. Vita, Professor of Medicine, Boston University
ClinicalTrials.gov Identifier: NCT00491751     History of Changes
Other Study ID Numbers: H-23184
Study First Received: June 22, 2007
Last Updated: May 23, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Boston University:
endothelium
nitric oxide
statins
ascorbic acid

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Ascorbic Acid
Atorvastatin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014