Dilution of Verapamil During Intraarterial Administration

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT05625503
Phase
EARLY_PHASE1
Status
Completed

Conditions

  • Burning
  • Pain
  • Vasospasm;Peripheral

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Verapamil — DRUG
    All patients routinely receive intra-arterial calcium channel blockers during transradial access for coronary angiography.
  • Nicardipine — DRUG
    Calcium channel blocker

Study Details

This study will be a randomized, single-blind, prospective trial designed to evaluate the efficacy and safety of intra-arterial (IA) Verapamil diluted with normal saline compared to undiluted IA Nicardipine during transradial access (TRA) for percutaneous coronary angiography. Patients who are 18 years or older and undergoing non-emergent percutaneous coronary angiography via TRA will be included. Patients who are non-English speaking, pregnant, or intubated will be excluded. Patients will be randomized to one of the two following groups: 1. Group 1 will receive IA Verapamil 5 mg (2mL) diluted with 8 mL of normal saline 2. Group 2 will receive IA Nicardipine 400 mcg (undiluted, 8 mL) The investigators will document the patient's level of discomfort on the Visual Analogue Scale 30 seconds before and after administration of IA Verapamil/Nicardipine. The investigators will also document the presence of radial artery spasms.

Key Dates

Start date
Dec 13, 2022
Status verified
Nov 2024
Primary completion
Dec 1, 2023
Completion
Dec 1, 2023

Study Design

Enrollment
55 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Verapamil
    Intra-arterial Verapamil 5 mg (2mL) diluted with 8 mL of normal saline
  • Placebo Comparator: Nicardipine
    Intra-arterial Nicardipine 400 mcg undiluted (8mL)

Primary Outcome Measure

Radial Artery Spasm [ Time Frame: approximately 30 minutes ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois HospitalChicagoIllinois60612-

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