Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs
Information source: Instituto de Cardiologia de Santa Catarina
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiac Catheterisation
Intervention: Nitroglycerin (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Instituto de Cardiologia de Santa Catarina Official(s) and/or principal investigator(s): Roberto L da Silva, MD, Principal Investigator, Affiliation: Instituto de Cardiologia de Santa Catarina
Overall contact: Roberto L da Silva, MD, Phone: 554899099790, Email: roberto.leo@ufsc.br
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.
Clinical Details
Official title: Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Pain assessment using visual analogue scale
Secondary outcome: Procedure durationRadiation exposure
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Roberto L da Silva, MD, Phone: 554899099790, Email: roberto.leo@ufsc.br Additional Information
Starting date: February 2015
Last updated: January 20, 2015
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