Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs

Instituto de Cardiologia de Santa Catarina

Status and phase: Completed; Phase 3

Conditions: Cardiac Catheterisation

Treatments: Drug: Nitroglycerin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02343276

ICSC-2015

Details and patient eligibility

About

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.

Enrollment: 328 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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328 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Intervention

Experimental group

Description:

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

Treatment:

Drug: Nitroglycerin