Dilution of Verapamil During Intraarterial Administration

Does Dilution of Verapamil With Normal Saline or Blood Reduce Discomfort Felt During Intraarterial Administration?

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Vasospasm;Peripheral; Burning
• Intervention / Treatment: Drug: Verapamil; Drug: Nicardipine

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Keshav R Patel, MD MS; Phone Number: 734-306-3130; Email: kpate447@uic.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• English Speaking patients who are age 18 or older
• Patient must be able to provide own consent and communicate with staff
• Patient's undergoing transradial access (TRA) for the left heart catheterization (LHC)

Exclusion Criteria

• Intubated or sedated patients
• Agitated patients requiring moderate sedation prior to TRA
• Patient's undergoing femoral access for the LHC
• Non-English speaking patients
• Contraindications to Verapamil or Nicardipine: including allergies to these medications, hypotension (mean arterial pressure <65), Bradycardia (heart rate<40)
• Emergent cardiac catheterization
• Inability to obtain radial artery access
• Conversion to radial artery access from another access site

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Verapamil; Intra-arterial Verapamil 5 mg (2mL) diluted with 8 mL of normal saline	Drug: Verapamil; All patients routinely receive intra-arterial calcium channel blockers during transradial access for coronary angiography.; Other Names: Calcium channel blocker
Placebo Comparator: Nicardipine; Intra-arterial Nicardipine 400 mcg undiluted (8mL)	Drug: Nicardipine; Calcium channel blocker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radial Artery Spasm	The investigators will document the presence or absence of radial artery spasms with either 0,1, or 2. 0 will indicate no radial artery spasms. 1 will indicate radial artery spasms that did not require a change in strategy. 2 will indicate radial artery spasms that required a change in strategy such as alternate access.	approximately 30 minutes
Pain Prior to Intra-arterial Calcium Channel Blocker Administration	Pain prior to intra-arterial calcium channel blocker administration will be assessed through the Visual Analogue Pain scale (from 0 to 10).	30 seconds prior to administration
Pain After Intra-arterial Calcium Channel Blocker Administration	Pain after intra-arterial calcium channel blocker administration will be assessed through the Visual analogue Pain Scale (from 0 to 10).	30 seconds post administration

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Investigators: Principal Investigator: Khalil Ibrahim, MD, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2022
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: November 11, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: cardiac catheterization; radial artery spasm; intra-arterial calcium channel blockers
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Verapamil; Nicardipine; Calcium Channel Blockers
• Other Study ID Numbers: 2022-0722

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No