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Dilution of Verapamil During Intraarterial Administration

NCT05625503 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2024-11-27

No results posted yet for this study

Summary

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.

Conditions

  • Vasospasm;Peripheral
  • Burning
  • Pain

Interventions

DRUG

Verapamil

All patients routinely receive intra-arterial calcium channel blockers during transradial access for coronary angiography.

DRUG

Nicardipine

Calcium channel blocker

Sponsors & Collaborators

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Khalil Ibrahim, MD · University of Illinois at Chicago

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-13
Primary Completion
2023-12-01
Completion
2023-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05625503 on ClinicalTrials.gov