Nitrate Use to Obtain Radial Spasm Embarrassment (NURSE - TTS Trial) (NURSE-TTS)

A Randomised, Double-blind, Parallel Group, Efficacy and Safety Study of Transdermal Patch Nitroglycerin in the Prevention of Coronary Artery Spasm, During Coronary Angiography/ Angioplasty (NURSE-TTS - Nitrate Use to Obtain Radial Spasm Embarrassment)

Transradial cardiac catheterization and percutaneous coronary intervention are increasingly being performed worldwide in elective and emergency procedures, with many centres adopting the transradial route as their first choice of arterial access. One of the most common complications encountered during transradial procedures is radial artery spasm. The aim of this study is to evaluate the Efficacy and Safety of the use of transdermal Glyceryl trinitrate patches applied to skin before cardiac catheterization to prevent the occurrence of radial artery spasm during transradial access cardiac catheterization.

Study Overview

• Status: Recruiting
• Conditions: Radial Artery Spasm
• Intervention / Treatment: Drug: Transdermal glyceryl trinitrate 10mg patches; Drug: Placebo patches

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Fotios Oikonomou, MD, PhD; Phone Number: 00306977618318; Email: economouf@gmail.com
• Study Contact Backup: Name: Ioannis Doundoulakis, MD; Phone Number: 00306946002830; Email: doudougiannis@gmail.com

Study Locations

• Greece
  • Thessaloniki, Greece, 56429
    • Recruiting
    • 424 GeneralMH
    • Contact: Fotios Oikonomou, MD, PhD; Phone Number: +306977618318; Email: economouf@gmail.com
    • Principal Investigator: Fotios Oikonomou, MD, Phd
    • Sub-Investigator: Ioannis Doundoulakis, MD
    • Sub-Investigator: Myrto Samara, MD, PhD
    • Sub-Investigator: Iliada Kalamakidou, RN
    • Sub-Investigator: Georgios Papazisis, MD, Phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female 18 -85 years old who has been admitted for scheduled coronary angiography by radial artery

Exclusion Criteria:

• Prior same radial artery catheterization
• Positive Allen test
• Severe Hypotension (SBP<100 mmHg)
• Pregnancy
• Ongoing Acute Myocardial Infarction
• Ongoing cardiogenic shock
• Known History of Nitrates intolerance/allergy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transdermal glyceryl trinitrate patches	Drug: Transdermal glyceryl trinitrate 10mg patches; Transdermal patches applied to skin 30 minutes before cardiac catheterization; Other Names: Nitrong tts 10mg- Lavipharm S.A.
Placebo Comparator: Transdermal placebo patches	Drug: Placebo patches; Transdermal placebo patches applied to skin 30 minutes before cardiac catheterization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radial Spasm occurrence	Radial spasm is measured by the exerting force (in Newton) removing the sheath from the patient	Immediately after the end of the procedure
Successful radial puncture	The success is defined by the fast radial puncture and catheterization and is measured by the time of radial catheterization	During radial puncture and catheterization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VRS-4 pain scale	The pain during the procedure is measured by the four-category verbal rating scale (VRS-4)	During the whole procedure
State-Trait Anxiety Inventory (STAI)	The anxiety during the procedure is measured by the State - Trait Anxiety Inventory (STAI)	During the whole procedure

Collaborators and Investigators

• Sponsor: 424 General Military Hospital
• Collaborators: Aristotle University Of Thessaloniki

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: February 20, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 20, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Spasm; Muscle Cramp; Vasodilator Agents; Nitroglycerin
• Other Study ID Numbers: 27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No