Is Verapamil In TransRadial Interventions OmittabLe?

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Background Verapamil is traditionally applied prophylactically in transradial procedures to prevent radial artery spasm. However, verapamil may have side effects and is contraindicated in some clinical settings.

Methods: During an investigator-initiated, randomized, double-blind trial, we evaluate the need for preventive verapamil administration. After vascular access is established, patients receive either 5 mg verapamil (n=297) or placebo (n=294). We compare the rate of access site conversions as primary end point using a superiority margin of 5%. Occurrence of code breaks (composite of conversions and unplanned use of verapamil), overall verapamil use, procedural and fluoroscopic times, contrast volume, and subjective pain are investigated as secondary end points.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State Health Center, Hungary
• Treatments: Verapamil

Criteria

Inclusion Criteria:

• patients undergoing transradial coronary angiography and/or percutaneous coronary intervention

• successful cannulation of the radial artery

Exclusion Criteria:

• reduced left ventricular systolic function (LVEF<35%)

• significant aortic stenosis

• bradycardia (<50/min.)

• myocardial infarction complicated by cardiogenic shock and/or high grade AV block