Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00491751 · ClinicalTrials.gov registry record · Phase 1
Clinical Utility of Endothelial Dysfunction in PAD
A Phase 1 study, sponsored by Boston University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 108
- Enrollment target
NCT00491751: Clinical Trial Phase 1 study, sponsored by Boston University.
NCT00491751 is a Phase 1 study that was terminated before completion, run by Boston University. The registered enrollment target is 108 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00491751, a Phase 1 study, was terminated before completion, sponsored by Boston University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 108 participants
- Enrollment target
Study 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.
Primary Outcome
Change in flow mediated dilation with treatment: FMD visit 2 - FMD visit 1 FMD is measured by using vascular ultrasound to determine the baseline diameter of the brachial artery. Endothelium-dependent vasodilation is induced by 5-minute arterial occlusion with a blood pressure cuff. When the cuff is released, the resultant increase in blood flow (reactive hyperemia) stimulates vasodilation of the brachial artery. This flow-mediated dilation (FMD) is expressed as the percent change from baseline.
Interventions
- DRUG Placebo
- DRUG ascorbic acid
- DRUG atorvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2004-05 |
| Est. Completion | 2012-06 |
| Phase | Phase 1 |
Why NCT00491751 stopped before completion
NCT00491751 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00491751 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00491751 about?
NCT00491751 is a clinical study titled "Clinical Utility of Endothelial Dysfunction in PAD". 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 ...
What is the current status of trial NCT00491751?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 108 participants. The study started on 2004-05. Estimated completion is 2012-06.
What interventions are being tested in trial NCT00491751?
The interventions under investigation include: Placebo (DRUG), ascorbic acid (DRUG), atorvastatin (DRUG).
Who is sponsoring clinical trial NCT00491751?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00491751's enrollment target sits among peer trials
108 523rd of 2000 higher than 1,470 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02703207 · 108 participants · NA
Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
- NCT02744677 · 108 participants · NA
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
- NCT02781883 · 108 participants · Phase 2
Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML
- NCT03848663 · 108 participants · NA
Visual Remapping to Aid Reading With Field Loss
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia