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Prevention of Radial Artery Occlusion After Transradial Access Using Nitroglycerin

NCT ID: NCT03158532

Last Updated: 2024-12-09

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2040 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-06

Study Completion Date

2021-11-01

Brief Summary

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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

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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.

Conditions

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Injury of Radial Artery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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).

Group Type PLACEBO_COMPARATOR

Placebo I

Intervention Type DRUG

Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.

Placebo II

Intervention Type DRUG

Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.

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).

Group Type EXPERIMENTAL

Nitroglycerin I

Intervention Type DRUG

500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.

Placebo II

Intervention Type DRUG

Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.

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).

Group Type ACTIVE_COMPARATOR

Placebo I

Intervention Type DRUG

Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.

Nitroglycerin II

Intervention Type DRUG

500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.

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).

Group Type EXPERIMENTAL

Nitroglycerin I

Intervention Type DRUG

500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.

Nitroglycerin II

Intervention Type DRUG

500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.

Interventions

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Nitroglycerin I

500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.

Intervention Type DRUG

Placebo I

Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.

Intervention Type DRUG

Nitroglycerin II

500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.

Intervention Type DRUG

Placebo II

Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.

Intervention Type DRUG

Other Intervention Names

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Tridil Saline Tridil Saline

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Cardiologia de Santa Catarina

OTHER

Sponsor Role lead

Responsible Party

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Roberto Léo da Silva

Intervencional cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roberto L da Silva, MD

Role: STUDY_CHAIR

Instituto de Cardiologia de Santa Catarina

José R Costa Júnior, PhD

Role: STUDY_DIRECTOR

Instituto Dante Pazzanese de Cardiologia

Locations

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Hospital Universitário Professor Polydoro Ernani de São Thiago

Florianópolis, Santa Catarina, Brazil

Site Status

Instituto de Cardiologia de Santa Catarina

São Jose, Santa Catarina, Brazil

Site Status

Irmandade Santa Casa Misericórdia Marília

Marília, São Paulo, Brazil

Site Status

Countries

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Brazil

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Nitroglycerin on Occlusion

Identifier Type: -

Identifier Source: org_study_id