The Role of Verapamil in Radial Artery Spasm

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-05

Study Completion Date

2024-11-15

Brief Summary

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Coronary angiography (CAG) is an invasive imaging method performed to determine the degree of coronary artery disease. Radial artery spasm (RAS) is one of the most common complications during coronary angiography performed via the transradial approach, causing patient discomfort or sometimes interrupting the procedure. There are many studies on RAS, and various pharmacoagents administered intravenously (intraarterial) to prevent RAS have been described. However, there is limited data in the literature regarding oral pharmacoagents that will prevent this complication. In our study, the preventive effect of Verapamil, given orally 2 hours before coronary angiography, on radial artery spasm will be investigated.

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Detailed Description

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Transradial access (TRA) has emerged as the preferred modality for vascular access in coronary interventions worldwide, prompting growing interest in its potential applications across other interventional specialties, especially in neurovascular procedures. Radial artery spasm (RAS) remains the most common complication of TRA, often causing procedural difficulties, patient discomfort, and an increased risk of access site crossover. The incidence of radial artery spasm reported in the literature varies widely, with estimates ranging from 4% to over 51.3%, influenced by factors such as definitions, patient selection, and the operator's experience.

After puncturing the radial artery (Puncture-induced RAS) and inserting the sheath-but before administering intra-arterial spasmolytics-local discomfort and pain may trigger a sympathetic vasoconstrictive response, potentially leading to the onset of RAS.

A previous study has stated that preventing RAS is more effective than treating it after it has been established. In this context, we will conduct a randomized controlled trial to evaluate the efficacy of 120 mg of oral verapamil administered two hours before radial artery puncture in reducing the incidence of radial artery spasm (RAS)

Conditions

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Radial Artery Spasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Placebo

No other vasodilating drug such as nitrate will be given intravenously

Group Type PLACEBO_COMPARATOR

Verapamil

Intervention Type DRUG

Prevent

Verapamil

Verapamil will be given orally at least 2 hours before angiography

Group Type ACTIVE_COMPARATOR

Verapamil

Intervention Type DRUG

Prevent

Interventions

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Verapamil

Prevent

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who undergo daily coronary angiography
* Whose Allen test is normal.
* Must be able to swallow tablets

Exclusion Criteria

* Allen test results are distorted,
* No pulse in the radial artery,
* Patients who have previously undergone radial angiography and whose hemodynamics are compromised will be excluded from the study.
* Patients with known contraindications to verapamil (significant aortic stenosis, heart rate \<50/min, high-grade atrioventricular block, myocardial infarction) complicated with cardiogenic shock, or left ventricular ejection fraction \<35%).

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No