Clinical Utility of Endothelial Dysfunction in PAD
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Joseph A. Vita, Boston University
First received: June 22, 2007
Last updated: May 23, 2012
Last verified: May 2012
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.
Peripheral Arterial Disease
Drug: ascorbic acid
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
||Clinical Utility of Endothelial Dysfunction in PAD
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2012 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Male and female subjects age 21-99 years old.
- Peripheral Arterial Disease. PAD is defined clinically and by angiography, magnetic resonance imaging, vascular ultrasound, or ankle brachial index less than 0.9.
- Able to provide informed consent and complete the study procedure.
- Patients undergoing non-emergent vascular surgery (peripheral arterial bypass, abdominal aortic aneurysm repair, carotid endarterectomy, or limb amputation) or other non-cardiac surgery.
- Emergent or urgent surgery that must be performed sooner than one week after enrollment
- 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.
- Clinically evident major illness of other organ systems, including cancer, end-stage renal disease, hepatic failure, or other conditions that make participation inappropriate.
- 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.
- Patients with liver function tests or serum creatine kinase >3 times the upper limit of normal.
- Patients who have received an investigational drug within 30 days of enrollment.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00491751
|Boston Medical Center
|Boston, Massachusetts, United States, 02118 |
||Joseph A Vita, MD
||Professor of Medicine
No publications provided
||Joseph A. Vita, Professor of Medicine, Boston University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 22, 2007
||May 23, 2012
||United States: Institutional Review Board
United States: Food and Drug Administration
Keywords provided by Boston University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2013
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
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