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

424 General Military Hospital

Status and phase: Unknown; Phase 3

Conditions: Radial Artery Spasm

Treatments: Drug: Transdermal glyceryl trinitrate 10mg patches; Drug: Placebo patches

Study type: Interventional

Funder types: Other

Identifiers

NCT04766151

27

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Transdermal glyceryl trinitrate patches

Experimental group

Treatment:

Drug: Transdermal glyceryl trinitrate 10mg patches

Transdermal placebo patches

Placebo Comparator group

Treatment:

Drug: Placebo patches