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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05625503
Other study ID # 2022-0722
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date December 13, 2022
Est. completion date December 1, 2023

Study information

Verified date August 2023
Source University of Illinois at Chicago
Contact Keshav R Patel, MD MS
Phone 734-306-3130
Email kpate447@uic.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 1, 2023
Est. primary completion date November 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Illinois Hospital Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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