Peripheral Arterial Disease Clinical Trial
Official title:
Ultrasound Evaluation of the Change in Diameter of the Posterior Tibial Artery and Dorsalis Pedis Artery After the Administration of Topical Nitroglycerin.
Verified date | November 2019 |
Source | Deborah Heart and Lung Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
There have not been any published studies showing the use of topical nitroglycerin on the dilatory effect on the posterior tibial or dorsalis pedis arteries. The objective of this study is to determine the response of the posterior tibial artery and dorsalis pedis artery to topical administration of nitroglycerin. This study may provide further information for the utility of this artery in the treatment of peripheral arterial disease.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | March 30, 2020 |
Est. primary completion date | March 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients admitted to Deborah Heart & Lung Center. - Patients 18 years of age and older. Exclusion Criteria: - Patients who do not have the ability to provide informed written consent. - Patients with documented allergy to Nitroglycerin - Recent/chronic use of nitrates/vasodilatory medications. - Patients with a SBP <100, labile blood pressure, tachycardia, hemodynamic instability. - Patients with recent admission requiring antibiotics. - Patients who are pregnant or nursing. - Patients who have current or chronic liver, renal, rheumatologic, or neurological disease. - Patients who have had peripheral vascular procedures in the prior 30 days. - Patients who have had any procedure or operation during their current hospitalization. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Deborah Heart and Lung Center |
Beyer AT, Ng R, Singh A, Zimmet J, Shunk K, Yeghiazarians Y, Ports TA, Boyle AJ. Topical nitroglycerin and lidocaine to dilate the radial artery prior to transradial cardiac catheterization: a randomized, placebo-controlled, double-blind clinical trial: the PRE-DILATE Study. Int J Cardiol. 2013 Oct 3;168(3):2575-8. doi: 10.1016/j.ijcard.2013.03.048. Epub 2013 Apr 10. — View Citation
Chong AY, Lo T, George S, Ratib K, Mamas M, Nolan J. The effect of pre-procedure sublingual nitroglycerin on radial artery diameter and Allen's test outcome - Relevance to transradial catheterization. Cardiovasc Revasc Med. 2018 Mar;19(2):163-167. doi: 10.1016/j.carrev.2017.07.016. Epub 2017 Jul 29. — View Citation
Majure DT, Hallaux M, Yeghiazarians Y, Boyle AJ. Topical nitroglycerin and lidocaine locally vasodilate the radial artery without affecting systemic blood pressure: a dose-finding phase I study. J Crit Care. 2012 Oct;27(5):532.e9-13. doi: 10.1016/j.jcrc.2012.04.019. Epub 2012 Jun 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vessel Diameter after administration of NG topical | Determination of the diameter of the posterior tibial artery and dorsalis pedis artery before and after the administration of various doses of topical nitroglycerin. | 3 months |
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