Clinical trial NCT03158532: Prevention of Radial Artery Occlusion After Transradial Access Using Nitroglycerin
Official title: Prevention of Radial Artery Occlusion After Transradial Access Using Nitroglycerin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Injury of Radial Artery
Lead sponsor: Instituto de Cardiologia de Santa Catarina
Sponsor class: OTHER
First posted: 2017-05-18
Enrollment: 2040
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Radial Artery Occlusion
timeFrame: 2 to 24 hours after procedure
Secondary outcomes:
measure: Late Radial Artery Occlusion
timeFrame: 30 days after procedure
measure: Pain Assessment
timeFrame: up to 24 hours after procedure
measure: Spasm (Operator Evaluation)
timeFrame: During the realization of the procedure
measure: Procedure Duration
timeFrame: Duration of the procedure
measure: Radiation Exposure
timeFrame: During the procedure
Other outcomes:
Locations:
city: Florianópolis
country: Brazil
facility: Hospital Universitário Professor Polydoro Ernani de São Thiago
state: Santa Catarina
city: São Jose
country: Brazil
facility: Instituto de Cardiologia de Santa Catarina
state: SC
city: Marília
country: Brazil
facility: Irmandade Santa Casa Misericórdia Marília
state: São Paulo
Study officials:
affiliation: Instituto de Cardiologia de Santa Catarina
name: Roberto L da Silva, MD
role: STUDY_CHAIR
affiliation: Instituto Dante Pazzanese de Cardiologia
name: José R Costa Júnior, PhD
role: STUDY_DIRECTOR
References: