- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01402427
Is Verapamil In TransRadial Interventions OmittabLe? (VITRIOL)
Omission of Prophylactic Verapamil Use in Transradial Coronary Interventions
Background Verapamil is traditionally applied prophylactically in transradial procedures to prevent radial artery spasm. However, verapamil may have side effects and is contraindicated in some clinical settings.
Methods: During an investigator-initiated, randomized, double-blind trial, we evaluate the need for preventive verapamil administration. After vascular access is established, patients receive either 5 mg verapamil (n=297) or placebo (n=294). We compare the rate of access site conversions as primary end point using a superiority margin of 5%. Occurrence of code breaks (composite of conversions and unplanned use of verapamil), overall verapamil use, procedural and fluoroscopic times, contrast volume, and subjective pain are investigated as secondary end points.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Budapest, Hungary, 1134
- State Health Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients undergoing transradial coronary angiography and/or percutaneous coronary intervention
- successful cannulation of the radial artery
Exclusion Criteria:
- reduced left ventricular systolic function (LVEF<35%)
- significant aortic stenosis
- bradycardia (<50/min.)
- myocardial infarction complicated by cardiogenic shock and/or high grade AV block
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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Intraarterial administration of 10 mL saline.
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Active Comparator: Verapamil
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Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of Access Site Conversions
Time Frame: Occurrence of access site conversion will be assessed within 1 minute after completion of coronary angiography or intervention.
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Occurrence of access site conversion will be assessed within 1 minute after completion of coronary angiography or intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Code Breaks
Time Frame: Occurrence of code breaking will be assessed within 1 minute after completion of coronary angiography or intervention.
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Code break: a composite of access site conversion and unplanned use of vasodilators.
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Occurrence of code breaking will be assessed within 1 minute after completion of coronary angiography or intervention.
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Rate of Vasodilator Use
Time Frame: Vasodilator use will be assessed within 1 minute after completion of coronary angiography or intervention.
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Vasodilator use will be assessed within 1 minute after completion of coronary angiography or intervention.
|
|
Procedural Time
Time Frame: Procedural time will be assessed within 1 minute after completion of coronary angiography or intervention.
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Procedural time will be assessed within 1 minute after completion of coronary angiography or intervention.
|
|
Fluoroscopic Time
Time Frame: Fluoroscopic time will be assessed within 1 minute after completion of coronary angiography or intervention.
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Fluoroscopic time will be assessed within 1 minute after completion of coronary angiography or intervention.
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|
Contrast Volume
Time Frame: The amount of contrast medium will be assessed within 1 minute after completion of coronary angiography or intervention.
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The amount of contrast medium will be assessed within 1 minute after completion of coronary angiography or intervention.
|
|
Subjective Pain
Time Frame: Subjective pain will be assessed within 1 minute after completion of coronary angiography or intervention.
|
Analysis of the rates of significant pain defined as pain score ≥4 on a semiquantitative scale ranging from 1 to 6.
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Subjective pain will be assessed within 1 minute after completion of coronary angiography or intervention.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Istvan Hizoh, MD, PhD, State Health Center, Budapest, Hungary
- Study Chair: Robert Gabor Kiss, MD, PhD, State Health Center, Budapest, Hungary
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Coronary Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Verapamil
Other Study ID Numbers
- SHCCARD-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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