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Ultrasound Evaluation of Lower Extremity Arteries After Topical Nitroglycerin Administration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04155476
Recruitment Status : Not yet recruiting
First Posted : November 7, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Deborah Heart and Lung Center

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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Drug: Nitroglycerin Topical Product Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Ultrasound Evaluation of the Change in Diameter of the Posterior Tibial Artery and Dorsalis Pedis Artery After the Administration of Topical Nitroglycerin.
Estimated Study Start Date : December 30, 2019
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nitroglycerin exposure Drug: Nitroglycerin Topical Product
application of NG topical to dorsals pedis and posterior tibial arteries.

Placebo Comparator: Non-Nitroglycerin exposure Drug: Nitroglycerin Topical Product
application of NG topical to dorsals pedis and posterior tibial arteries.




Primary Outcome Measures :
  1. Vessel Diameter after administration of NG topical [ Time Frame: 3 months ]
    Determination of the diameter of the posterior tibial artery and dorsalis pedis artery before and after the administration of various doses of topical nitroglycerin.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Publications:
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Responsible Party: Deborah Heart and Lung Center
ClinicalTrials.gov Identifier: NCT04155476    
Other Study ID Numbers: 2k19-09
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Nitroglycerin
Vasodilator Agents