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Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs

NCT02343276 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2019-05-31

Study results available
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Summary

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.

Conditions

  • Cardiac Catheterisation

Interventions

DRUG

Nitroglycerin

Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion

OTHER

Placebo

Placebo (saline solution 10 ml) in radial artery after sheath insertion

Sponsors & Collaborators

  • Instituto de Cardiologia de Santa Catarina

    lead OTHER

Principal Investigators

  • Roberto L da Silva, MD · Instituto de Cardiologia de Santa Catarina

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Brazil

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02343276 on ClinicalTrials.gov