Clinical Utility of Endothelial Dysfunction in PAD
This study is ongoing, but not recruiting participants.
Sponsor:
Boston University
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
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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:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
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 May 23, 2013