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Dilution of Verapamil During Intraarterial Administration

Primary Purpose

Vasospasm;Peripheral, Burning, Pain

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Verapamil
Nicardipine
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vasospasm;Peripheral focused on measuring cardiac catheterization, intra-arterial calcium channel blockers, radial artery spasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Illinois HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Verapamil

Nicardipine

Arm Description

Intra-arterial Verapamil 5 mg (2mL) diluted with 8 mL of normal saline

Intra-arterial Nicardipine 400 mcg undiluted (8mL)

Outcomes

Primary Outcome Measures

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.
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).
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).

Secondary Outcome Measures

Full Information

First Posted
November 11, 2022
Last Updated
August 21, 2023
Sponsor
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT05625503
Brief Title
Dilution of Verapamil During Intraarterial Administration
Official Title
Does Dilution of Verapamil With Normal Saline or Blood Reduce Discomfort Felt During Intraarterial Administration?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago

4. Oversight

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
Data Monitoring Committee
No

5. 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: Group 1 will receive IA Verapamil 5 mg (2mL) diluted with 8 mL of normal saline 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasospasm;Peripheral, Burning, Pain
Keywords
cardiac catheterization, intra-arterial calcium channel blockers, radial artery spasm

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Verapamil
Arm Type
Active Comparator
Arm Description
Intra-arterial Verapamil 5 mg (2mL) diluted with 8 mL of normal saline
Arm Title
Nicardipine
Arm Type
Placebo Comparator
Arm Description
Intra-arterial Nicardipine 400 mcg undiluted (8mL)
Intervention Type
Drug
Intervention Name(s)
Verapamil
Other Intervention Name(s)
Calcium channel blocker
Intervention Description
All patients routinely receive intra-arterial calcium channel blockers during transradial access for coronary angiography.
Intervention Type
Drug
Intervention Name(s)
Nicardipine
Intervention Description
Calcium channel blocker
Primary Outcome Measure Information:
Title
Radial Artery Spasm
Description
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.
Time Frame
approximately 30 minutes
Title
Pain Prior to Intra-arterial Calcium Channel Blocker Administration
Description
Pain prior to intra-arterial calcium channel blocker administration will be assessed through the Visual Analogue Pain scale (from 0 to 10).
Time Frame
30 seconds prior to administration
Title
Pain After Intra-arterial Calcium Channel Blocker Administration
Description
Pain after intra-arterial calcium channel blocker administration will be assessed through the Visual analogue Pain Scale (from 0 to 10).
Time Frame
30 seconds post administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keshav R Patel, MD MS
Phone
734-306-3130
Email
kpate447@uic.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khalil Ibrahim, MD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Dilution of Verapamil During Intraarterial Administration

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