Prevention of Radial Artery Occlusion After Transradial Access Using Nitroglycerin

Injury of Radial Artery Clinical Trial

— Patens  

Official title:

Prevention of Radial Artery Occlusion After Transradial Access Using Nitroglycerin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03158532
• Other study ID #: Nitroglycerin on Occlusion
• Status: Recruiting
• Phase: Phase 3
• Start date: July 6, 2017
• Est. completion date: November 30, 2020

Study information

• Verified date: February 2020
• Source: Instituto de Cardiologia de Santa Catarina
• Contact: Roberto L da Silva, MD
• Phone: +55 48 32719077
• Email: roberto.leo[@]ufsc.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The radial approach for a coronary angiography has became popular in several centers because of its simplicity and fewer complications. The radial artery occlusion (RAO) is the main inconvenient and impose a limitation of future use of the radial artery as an access site for catheterization in the future. Several strategies have been used to decrease the incidence of RAO (heparin, patent hemostasis, etc). Nitrates in intra-arterial have been widely studied in prevention of this spasm. Current data show that nitroglycerin intra-arterial at the end of the procedure reduce the incidence of RAO. The hypothesis that use of nitroglycerin at the start of catheterization would have the same effect was not tested.

Description:

Transradial access (TRA) has been increasingly adopted for diagnostic and interventional cardiovascular procedures in many centers worldwide. This is largely driven by the evidence supporting an unequivocal reduction in access site-related complications associated with TRA compared with transfemoral access, as well as reduction in cost and increased patient comfort. The radial artery occlusion (RAO) is the main inconvenient and impose a limitation of future use of the radial artery as an access site for catheterization in the future. RAO is the most commun complication of transradial access, and its incidence continues to reach up to 12%.

Nitrates in intra-arterial have been widely studied in prevention of this spasm. Nitroglycerin binds to the surface of endothelial cells and undergoes two chemical reductions to form nitric oxide (NO). The nitric oxide then moves out of the endothelial cell and into an adjacent smooth muscle cell, where it promotes the formation of cyclic guanosine monophosphate (cGMP), which then promotes muscle relaxation. Current data show that nitroglycerin intra-arterial at the end of the procedure reduce the incidence of radial artery occlusion.

A big sheath to artery size ratio could reduce the incidence of RAO, so the main objective of this study is to evaluate whether administration of nitroglycerin at the start of a transradial procedure may preserve the patency of the radial artery; as well, confirm if nitroglycerin administration just before sheet removal helps to keep the radial artery patency.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2128
• Est. completion date: November 30, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Indication for cardiac catheterization;

• Suitable candidates for transradial approach;

• Use of 5 or 6 French sheath in the procedure;

• Signed informed consent.

Exclusion Criteria:

• Unable to tolerate nitrates or known allergy to nitrates;

• Use of any nitrate, by any route of administration, up to 1 hour before the procedure;

• ST-segment elevation acute myocardial infarction patients during the first 12 hours of sympton onset;

• Intubated patients (on mechanical ventilation);

• Complications before or during procedure (cardiac arrest, pulmonary edema, cardiogenic shock, stroke);

• Prior inclusion in this trial.

Related Conditions & MeSH terms

• Injury of Radial Artery

Intervention

Drug:
• Nitroglycerin I
500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.
• Placebo I
Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.
• Nitroglycerin II
500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
• Placebo II
Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.

Locations

Country	Name	City	State
Brazil	Instituto de Cardiologia do Distrito Federal	Brasília	Distrito Federal
Brazil	Hospital Universitário Professor Polydoro Ernani de São Thiago	Florianópolis	Santa Catarina
Brazil	Irmandade Santa Casa Misericórdia Marília	Marília	São Paulo
Brazil	Instituto de Cardiologia de Santa Catarina	São Jose	SC
Brazil	Instituto Dante Pazzanese de Cardiologia	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Cardiologia de Santa Catarina

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radial artery occlusion	Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular doppler ultrasound	2 to 24 hours after procedure
Secondary	Late radial artery occlusion	Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular doppler ultrasound	30 days after procedure
Secondary	Pain assessment	Pain felt by the patient in the forearm, assessed using numeric pain rating scale	up to 24 hours after procedure
Secondary	Spasm (operator evaluation)	Catheter friction, as experienced by the operator (subjective measure)	Immediate
Secondary	Procedure duration	Total duration of the procedure, from puncture to haemostatic dressing.	Immediate
Secondary	Radiation exposure	Total radiation used in the procedure	Immediate