Status:
COMPLETED
Effect of Transcutaneous Vagal Stimulation (TVS) on Endothelial Function in PAD
Lead Sponsor:
University of Oklahoma
Conditions:
Peripheral Artery Disease
Endothelial Dysfunction
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Peripheral arterial disease (PAD) constitutes a major public health burden. The incidence of PAD increases with age and is associated with other comorbid cardiovascular disorders. Atherosclerosis whic...
Eligibility Criteria
Inclusion
- peripheral arterial disease (PAD) - patients with an ankle-brachial index of \<0.9
- symptoms of intermittent claudication, rest pain, or minor tissue loss (Rutherford category I-V)
Exclusion
- patients with acute limb ischemia
- Patients with overt congestive heart failure / recent acute myocardial infarction (\< 3 months)
- Premenopausal women and post-menopausal women on hormone supplements.
- chronic inflammatory disease (systemic lupus erythematosus, rheumatoid arthritis, and Crohn's disease), or receiving therapy with steroids, cyclosporine, methotrexate or immunocompromised patients.
- unilateral or bilateral vagotomy
- Patients with bilateral upper extremity amputation
- pregnant patients
- prisoners
- end-stage renal disease.
- End-stage liver disease.
- patients with BMI\>34
- Patients with upper extremity arterial disease
- history of recurrent vasovagal syncope, Sick sinus syndrome, 2nd- or 3rd-degree atrioventricular block (AV) block, prolonged first degree AV block.
- Refusal to sign a consent form.
- Significant hypotension from autonomic dysfunction
- Patients with pacemakers who have significant interaction with TVNS during testing
Key Trial Info
Start Date :
December 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2020
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03445754
Start Date
December 11 2017
End Date
May 30 2020
Last Update
June 11 2024
Active Locations (1)
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1
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73117