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

Radial Artery Spasm Clinical Trial

— NURSE-TTS  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04766151
• Other study ID #: 27
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2021
• Source: 424 General Military Hospital
• Contact: Fotios Oikonomou, MD, PhD
• Phone: 00306977618318
• Email: economouf[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Cramp
• Radial Artery Spasm
• Spasm

Intervention

Drug:
• Transdermal glyceryl trinitrate 10mg patches
Transdermal patches applied to skin 30 minutes before cardiac catheterization
• Placebo patches
Transdermal placebo patches applied to skin 30 minutes before cardiac catheterization

Locations

Country	Name	City	State
Greece	424 GeneralMH	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
424 General Military Hospital	Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	VRS-4 pain scale	The pain during the procedure is measured by the four-category verbal rating scale (VRS-4)	During the whole procedure
Secondary	State-Trait Anxiety Inventory (STAI)	The anxiety during the procedure is measured by the State - Trait Anxiety Inventory (STAI)	During the whole procedure