DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 duration

Radiation 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017