Overview

This trial is active, not recruiting.

Condition peripheral arterial disease
Treatments atorvastatin, ascorbic acid, placebo
Sponsor Boston University
Start date May 2004
End date June 2012
Trial size 400 participants
Trial identifier NCT00491751, H-23184

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose diagnostic

Primary Outcomes

Measure
Brachial artery flow-mediated dilation
time frame: 30 days

Secondary Outcomes

Measure
Pulse wave velocity
time frame: 30 days
Markers of inflammation
time frame: 30 days

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Clinical Utility of Endothelial Dysfunction in PAD
Principal investigator Joseph A Vita, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by Boston University.