Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs

Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs.

Single-center study, randomized, double-blind, placebo controlled, with patients undergoing diagnostic or therapeutic catheterization via the transradial approach. Patients will be randomized into two groups: one group will receive the vasodilator nitroglycerin during the procedure (intervention group), and a second group will receive saline 0.9% in the same volume and time during the procedure (control group).

Will be evaluated: incidence of spasms of the radial artery, ability to perform the procedure without the need to change the access site, pain presented by the patient, time and total radiation of the procedure.

Study Overview

• Status: Completed
• Conditions: Cardiac Catheterisation
• Intervention / Treatment: Other: Placebo; Drug: Nitroglycerin

• Study Type: Interventional
• Enrollment (Actual): 328
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • SC
    • São Jose, SC, Brazil, 88000
      • Instituto de Cardiologia de Santa Catarina

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

Exclusion Criteria:

• AMI
• Intubated patients
• Complications 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: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo (saline solution 10 ml) in radial artery after sheath insertion	Other: Placebo; Placebo (saline solution 10 ml) in radial artery after sheath insertion; Other Names: Saline solution
Experimental: Intervention; Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion	Drug: Nitroglycerin; Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion; Other Names: Tridil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Assessment Using Visual Analogue Scale	the patients' feeling of pain in the forearm, and it was measured using a visual analogue scale (VAS), applied at the end of the procedure by an interventional nurse. The VAS consists of a single line measuring 100 mm, anchored by verbal descriptors, saying 'no pain' and 'worst possible pain'. Higher values mean a worse pain.	Five minutes after sheath removal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Duration	Procedure duration, from artery catheterization up to removal of sheath.	Immediate
Radiation Exposure	Total radiation required to complete the procedure.	Immediate

Collaborators and Investigators

• Sponsor: Instituto de Cardiologia de Santa Catarina
• Investigators: Principal Investigator: Roberto L da Silva, MD, Instituto de Cardiologia de Santa Catarina

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: January 15, 2015
• First Submitted That Met QC Criteria: January 20, 2015
• First Posted (Estimate): January 21, 2015

Study Record Updates

• Last Update Posted (Actual): May 31, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Radial Spasm
• Additional Relevant MeSH Terms: Vasodilator Agents; Nitroglycerin
• Other Study ID Numbers: ICSC-2015