Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs

Cardiac Catheterisation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02343276
• Other study ID #: ICSC-2015
• Status: Completed
• Phase: Phase 3
• Start date: February 2015
• Est. completion date: August 2015

Study information

• Verified date: February 2019
• Source: Instituto de Cardiologia de Santa Catarina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Catheterisation

Intervention

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

Locations

Country	Name	City	State
Brazil	Instituto de Cardiologia de Santa Catarina	São Jose	SC

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Cardiologia de Santa Catarina

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Procedure Duration	Procedure duration, from artery catheterization up to removal of sheath.	Immediate
Secondary	Radiation Exposure	Total radiation required to complete the procedure.	Immediate