Dilution of Verapamil During Intraarterial Administration

NCT05625503 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 2022-0722
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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. 1.Group 1 will receive IA Verapamil 5 mg (2mL) diluted with 8 mL of normal saline
2. 2.Group 2 will receive IA Nicardipine 400 mcg (undiluted, 8 mL)

Conditions

Vasospasm;Peripheral; Burning; Pain

Keywords

cardiac catheterization; intra-arterial calcium channel blockers; radial artery spasm

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Verapamil

ACTIVE COMPARATOR

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

Drug: Verapamil

Nicardipine

PLACEBO COMPARATOR

Intra-arterial Nicardipine 400 mcg undiluted (8mL)

Drug: Nicardipine

Interventions

Verapamil DRUG

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

Also known as: Calcium channel blocker

Verapamil

Nicardipine DRUG

Calcium channel blocker

Nicardipine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Hospital

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Paresthesia; Pain

Interventions

Verapamil; Calcium Channel Blockers; Nicardipine

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenethylamines; Ethylamines; Amines; Organic Chemicals; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Cardiovascular Agents; Therapeutic Uses; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Khalil Ibrahim, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 23, 2022
• Study Start: December 13, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

US (1)