MedTrace Logo

Clinical Utility of Endothelial Dysfunction in PAD

NCT00491751 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2018-07-27

Study results available
· View outcomes & findings →

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.

Conditions

  • Peripheral Arterial Disease

Interventions

DRUG

atorvastatin

atorvastatin 40 or 80 mg/day

DRUG

ascorbic acid

ascorbic acid 500 mg/day

DRUG

Placebo

matching placebo

Sponsors & Collaborators

  • Boston University

    lead OTHER

Principal Investigators

  • Naomi Hamburg, MD · Boston University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2012-06-30
Completion
2012-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00491751 on ClinicalTrials.gov