Ultrasound Evaluation of Lower Extremity Arteries After Topical Nitroglycerin Administration

NCT04155476 | Unknown Early Phase 1

• 1 other identifier: 2k19-09
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Nitroglycerin exposure

EXPERIMENTAL

Drug: Nitroglycerin Topical Product

Non-Nitroglycerin exposure

PLACEBO COMPARATOR

Drug: Nitroglycerin Topical Product

Interventions

Nitroglycerin Topical Product DRUG

application of NG topical to dorsals pedis and posterior tibial arteries.

Nitroglycerin exposure; Non-Nitroglycerin exposure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to Deborah Heart \& Lung Center.
• Patients 18 years of age and older.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Deborah Heart and Lung Center: lead

Related Publications (3)

• 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.

  PMID: 23582415 BACKGROUND

• 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.

  PMID: 22699036 BACKGROUND

• 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.

  PMID: 28923695 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 7, 2019
• Study Start: December 30, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: November 8, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR