Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

328 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiac Catheterisation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Intervention

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

Group Type EXPERIMENTAL

Nitroglycerin

Intervention Type DRUG

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

Interventions

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Nitroglycerin

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Other Intervention Names

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Tridil Saline solution

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No