Dilution of Verapamil During Intraarterial Administration

NCT ID: NCT05625503

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-13

Study Completion Date

2023-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Vasospasm;Peripheral Burning Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Verapamil

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

Group Type ACTIVE_COMPARATOR

Verapamil

Intervention Type DRUG

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

Nicardipine

Intra-arterial Nicardipine 400 mcg undiluted (8mL)

Group Type PLACEBO_COMPARATOR

Nicardipine

Intervention Type DRUG

Calcium channel blocker

Interventions

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Verapamil

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

Intervention Type DRUG

Nicardipine

Calcium channel blocker

Intervention Type DRUG

Other Intervention Names

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Calcium channel blocker

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Khalil Ibrahim

Assistant Professor of Clinical Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Khalil Ibrahim, MD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

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University of Illinois Hospital

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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2022-0722

Identifier Type: -

Identifier Source: org_study_id