Prevention of Radial Artery Occlusion After Transradial Access Using Nitroglycerin (Patens)

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.

Study Overview

• Status: Unknown
• Conditions: Injury of Radial Artery
• Intervention / Treatment: Drug: Placebo I; Drug: Placebo II; Drug: Nitroglycerin I; Drug: Nitroglycerin II

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 2128
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Roberto L da Silva, MD; Phone Number: +55 48 32719077; Email: roberto.leo@ufsc.br

Study Locations

• Brazil
  • São Paulo, Brazil, 04012-909
    • Not yet recruiting
    • Instituto Dante Pazzanese de Cardiologia
    • Contact: Roberto L da Silva, MD; Phone Number: +55 48 999099790
    • Principal Investigator: José R Costa Júnior, PhD
  • Distrito Federal
    • Brasília, Distrito Federal, Brazil, 70658-700
      • Not yet recruiting
      • Instituto de Cardiologia do Distrito Federal
      • Contact: Luciano M Santos, MD; Phone Number: +55 61 3403-5400
      • Principal Investigator: Luciano M Santos, MD
  • SC
    • São Jose, SC, Brazil, 88000
      • Recruiting
      • Instituto de Cardiologia de Santa Catarina
      • Principal Investigator: Roberto L da Silva, MD
      • Contact: Roberto L da Silva, MD; Phone Number: 55 48 32719077; Email: roberto.leo@ufsc.br
  • Santa Catarina
    • Florianópolis, Santa Catarina, Brazil, 88036-800
      • Not yet recruiting
      • Hospital Universitário Professor Polydoro Ernani de São Thiago
      • Contact: Thaís RW da Silva, PhD; Phone Number: +55 48 37219100
      • Sub-Investigator: Thaís RW da Silva, MD
      • Principal Investigator: Roberto L da Silva, MD
  • São Paulo
    • Marília, São Paulo, Brazil, 17515-900
      • Not yet recruiting
      • Irmandade Santa Casa Misericórdia Marília
      • Contact: Pedro B Andrade, PhD; Phone Number: +55 14 3402-5555
      • Principal Investigator: Pedro B Andrade, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo I/Placebo II; 0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).	Drug: Placebo I; Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.; Other Names: Saline; Drug: Placebo II; Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.; Other Names: Saline
EXPERIMENTAL: Nitroglycerin I/Placebo II; 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).	Drug: Placebo II; Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.; Other Names: Saline; Drug: Nitroglycerin I; 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.; Other Names: Tridil
ACTIVE_COMPARATOR: Placebo I /Nitroglycerin II; 0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).	Drug: Placebo I; Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.; Other Names: Saline; Drug: Nitroglycerin II; 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.; Other Names: Tridil
EXPERIMENTAL: Nitroglycerin I /Nitroglycerin II; 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).	Drug: Nitroglycerin I; 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.; Other Names: Tridil; Drug: Nitroglycerin II; 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.; Other Names: Tridil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Instituto de Cardiologia de Santa Catarina
• Investigators: Study Chair: Roberto L da Silva, MD, Instituto de Cardiologia de Santa Catarina; Study Director: José R Costa Júnior, PhD, Instituto Dante Pazzanese de Cardiologia

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 6, 2017
• Primary Completion (ANTICIPATED): October 31, 2020
• Study Completion (ANTICIPATED): November 30, 2020

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (ACTUAL): May 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vasodilator Agents; Nitroglycerin
• Other Study ID Numbers: Nitroglycerin on Occlusion

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No