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

Phase 3

• Conditions: Radial Artery Spasm
• Interventions: Drug: Transdermal glyceryl trinitrate 10mg patches; Drug: Placebo patches

• Registration Number: NCT04766151
• Lead Sponsor: 424 General Military Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2021-02
• Study First Submitted: 2021-02-15
• Study First Submitted QC: 2021-02-20
• Last Update Submitted: 2021-02-20
• Study First Posted: 2021-02-23
• Last Update Posted: 2021-02-23
• Primary Completion: 2021-12-31
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transdermal glyceryl trinitrate patches	Transdermal glyceryl trinitrate 10mg patches	-
Transdermal placebo patches	Placebo patches	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

424 GeneralMH; 🇬🇷 Thessaloniki, Greece