Prevention of Radial Artery Occlusion After Transradial Access Using Nitroglycerin

NCT03158532 | Completed Phase 3 Results

• 1 other identifier: Nitroglycerin on Occlusion
• Study Type: interventional
• Target: 2,040
• Locations: 1 country
• Sites: 3

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.

Conditions

Injury of Radial Artery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Late Radial Artery Occlusion

  30 days after procedure

• Pain Assessment

  up to 24 hours after procedure

• Spasm (Operator Evaluation)

  During the realization of the procedure

• Procedure Duration

  Duration of the procedure

• Radiation Exposure

  During the procedure

Study Arms (4)

Placebo I/Placebo II

PLACEBO COMPARATOR

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; Drug: Placebo II

Nitroglycerin I/Placebo II

EXPERIMENTAL

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: Nitroglycerin I; Drug: Placebo II

Placebo I /Nitroglycerin II

ACTIVE COMPARATOR

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; Drug: Nitroglycerin II

Nitroglycerin I /Nitroglycerin II

EXPERIMENTAL

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; Drug: Nitroglycerin II

Interventions

Nitroglycerin I DRUG

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

Also known as: Tridil

Nitroglycerin I /Nitroglycerin II; Nitroglycerin I/Placebo II

Placebo I DRUG

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

Also known as: Saline

Placebo I /Nitroglycerin II; Placebo I/Placebo II

Nitroglycerin II DRUG

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

Also known as: Tridil

Nitroglycerin I /Nitroglycerin II; Placebo I /Nitroglycerin II

Placebo II DRUG

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

Also known as: Saline

Nitroglycerin I/Placebo II; Placebo I/Placebo II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication for cardiac catheterization;
• Suitable candidates for transradial approach;
• Use of 5 or 6 French sheath in the procedure;
• Signed informed consent.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Instituto de Cardiologia de Santa Catarina: lead

Study Sites (3)

Hospital Universitário Professor Polydoro Ernani de São Thiago

Florianópolis, Santa Catarina, 88036-800, Brazil

Location

Instituto de Cardiologia de Santa Catarina

São Jose, Santa Catarina, 88000, Brazil

Location

Irmandade Santa Casa Misericórdia Marília

Marília, São Paulo, 17515-900, Brazil

Location

MeSH Terms

Interventions

Nitroglycerin; Sodium Chloride

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Roberto Léo da Silva
• Organization: ISCS

robertoleo@hotmail.com

55 48 999099790

Study Officials

• Roberto L da Silva, MD

  Instituto de Cardiologia de Santa Catarina

  STUDY CHAIR

• José R Costa Júnior, PhD

  Instituto Dante Pazzanese de Cardiologia

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Intervencional cardiologist

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 18, 2017
• Study Start: July 6, 2017
• Primary Completion: October 1, 2021
• Study Completion: November 1, 2021
• Last Updated: December 9, 2024
• Results First Posted: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (3)