The effect of transdermal GTN on arterial size and procedure outcomes in transradial coronary angiography - pilot study. - GTN and Transradial Coronary Angiography

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000510-37-GB

Enrollment

100

Registered

2008-03-07

Start date

2008-04-25

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The trial is to investigate whether applying a transdermal GTN patch over the radial artery reduces spasm of the artery during coronary angiography. This is a pilot study

Interventions

Trade Name: Nitro-Dur Product Name: Nitro-Dur Pharmaceutical Form: Transdermal patch

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients referred for non-emergency coronary angiography, who are to be treated by one of two consultants who use the radial artery as the access site, (rather than the femoral artery). Patent Radial and Ulnar artery as determined by an Allen’s test Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Those who are not able to attend for ultrasound scans Those not suitable for transradial coronary angiography. Patients without clinical evidence of a patent Ulnar Artery on Allen’s test. Those with a clincically small Radial Artery. Any of the following contra-indications to GTN. Contra-indicated in patients hypersensitive to nitrates and in patients with marked anaemia. Extensive co-mobidites or pregnancy. Unable to given informed consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether transdermal GTN reduces the incidence of arterial spasm during coronary angiography. This is a pilot study to inform a possible furture RCT (which will be submitted to ethics, MHRA and R&D at a later date).;Secondary Objective: Whether the patch also eases cannulation, reduces procedure time and increases artery diameter on ultrasound.; Primary end point(s): Spasm will be the primary outcome as this is the most common complication and will be classified into three groups; mild, moderate and severe. Spasm will be recorded and subjectively measured by the cardiologist; this is the way spasm has been recorded in the literature. Mild spasm is when the patient reports pain or discomfort but no treatment is needed, moderate spasm is when a cocktail of drugs to relieve the spasm are needed to continue with the procedure and severe spasm is when despite the cocktail of drugs being given, the procedure has to be abandoned.	—

Measure

Time frame

Main Objective: To determine whether transdermal GTN reduces the incidence of arterial spasm during coronary angiography. This is a pilot study to inform a possible furture RCT (which will be submitted to ethics, MHRA and R&D at a later date).;Secondary Objective: Whether the patch also eases cannulation, reduces procedure time and increases artery diameter on ultrasound.; Primary end point(s): Spasm will be the primary outcome as this is the most common complication and will be classified into three groups; mild, moderate and severe. Spasm will be recorded and subjectively measured by the cardiologist; this is the way spasm has been recorded in the literature. Mild spasm is when the patient reports pain or discomfort but no treatment is needed, moderate spasm is when a cocktail of drugs to relieve the spasm are needed to continue with the procedure and severe spasm is when despite the cocktail of drugs being given, the procedure has to be abandoned.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026