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Dilution of Verapamil During Intraarterial Administration

Sponsor
University of Illinois at Chicago (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05625503
Collaborator
(none)
100
Enrollment
2
Arms
12.6
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Does Dilution of Verapamil With Normal Saline or Blood Reduce Discomfort Felt During Intraarterial Administration?
Anticipated Study Start Date :
Nov 14, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Radial Artery Spasm [approximately 30 minutes]

      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.

    2. Pain Prior to Intra-arterial Calcium Channel Blocker Administration [30 seconds prior to administration]

      Pain prior to intra-arterial calcium channel blocker administration will be assessed through the Visual Analogue Pain scale (from 0 to 10).

    3. Pain After Intra-arterial Calcium Channel Blocker Administration [30 seconds post administration]

      Pain after intra-arterial calcium channel blocker administration will be assessed through the Visual analogue Pain Scale (from 0 to 10).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Illinois at Chicago

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Khalil Ibrahim, Assistant Professor of Clinical Medicine, University of Illinois at Chicago
    ClinicalTrials.gov Identifier:
    NCT05625503
    Other Study ID Numbers:
    • 2022-0722
    First Posted:
    Nov 23, 2022
    Last Update Posted:
    Nov 23, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Keywords provided by Khalil Ibrahim, Assistant Professor of Clinical Medicine, University of Illinois at Chicago
    cardiac catheterization
    intra-arterial calcium channel blockers
    radial artery spasm
    Additional relevant MeSH terms:
    Burns
    Verapamil
    Nicardipine
    Calcium Channel Blockers

    Study Results

    No Results Posted as of Nov 23, 2022