The Role of Verapamil in Radial Artery Spasm
The Role of Oral Verapamil in Preventing Radial Spasm During Transradial Angiography
Study Overview
Detailed Description
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)
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Mersin, Turkey (Türkiye), 33010
- VM Medicalpark
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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%).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Verapamil
Verapamil will be given orally at least 2 hours before angiography
|
Prevent
|
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Placebo Comparator: Placebo
No other vasodilating drug such as nitrate will be given intravenously
|
Prevent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Clinical Radial Artery Spasm (RAS)
Time Frame: During the coronary angiography procedure (up to 2 hours from sheath insertion)
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Clinical RAS defined as presence of at least 2 of the following: (1) forearm pain ≥ 4/10, (2) pain during catheter manipulation, (3) catheter movement restriction, (4) pain during sheath removal, (5) difficulty in sheath removal.
|
During the coronary angiography procedure (up to 2 hours from sheath insertion)
|
|
Number of Participants With Ultrasonographically Confirmed Radial Artery Spasm (Ultrasonographic RAS)
Time Frame: During the procedure, immediately after catheterization (within 2 hours)
|
Radial artery spasm (RAS) was defined as luminal narrowing of ≥50% as measured by ultrasonography at the access site.
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During the procedure, immediately after catheterization (within 2 hours)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Procedural Success
Time Frame: During the procedure (from sheath insertion to procedure completion)
|
Procedure success was defined as completing coronary angiography or PCI using the initial radial artery approach without requiring a switch to an alternative access site.
|
During the procedure (from sheath insertion to procedure completion)
|
|
Mean Volume of Contrast Media Used (mL) (mL)
Time Frame: During the procedure (from sheath insertion to procedure completion)
|
The volume of contrast media (in ml) used was recorded
|
During the procedure (from sheath insertion to procedure completion)
|
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Mean of the Dose Area Product (DAP)
Time Frame: During the procedure (from sheath insertion to procedure completion)
|
The parameters collected for radiation exposure included the DAP
|
During the procedure (from sheath insertion to procedure completion)
|
|
Mean of the Fluoroscopy Time
Time Frame: During the procedure (from sheath insertion to procedure completion)
|
The parameters collected for radiation exposure included the fluoroscopy time (in minutes)
|
During the procedure (from sheath insertion to procedure completion)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sefa Sural, MD, Istinye University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MLP-SSURAL-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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