Study Results
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View full resultsBasic Information
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COMPLETED
NA
591 participants
INTERVENTIONAL
2011-03-31
2011-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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Verapamil
Verapamil
Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
Placebo
Placebo
Intraarterial administration of 10 mL saline.
Interventions
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Verapamil
Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
Placebo
Intraarterial administration of 10 mL saline.
Eligibility Criteria
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Inclusion Criteria
* successful cannulation of the radial artery
Exclusion Criteria
* significant aortic stenosis
* bradycardia (\<50/min.)
* myocardial infarction complicated by cardiogenic shock and/or high grade AV block
18 Years
ALL
No
Sponsors
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State Health Center, Hungary
OTHER
Responsible Party
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Istvan Hizoh, MD, PhD
Senior Consultant
Principal Investigators
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Istvan Hizoh, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
State Health Center, Budapest, Hungary
Robert Gabor Kiss, MD, PhD
Role: STUDY_CHAIR
State Health Center, Budapest, Hungary
Locations
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State Health Center
Budapest, , Hungary
Countries
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References
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Hizoh I, Majoros Z, Major L, Gulyas Z, Szabo G, Kerecsen G, Korda A, Molnar F, Kiss RG. Need for prophylactic application of verapamil in transradial coronary procedures: a randomized trial. The VITRIOL (is Verapamil In TransRadial Interventions OmittabLe?) trial. J Am Heart Assoc. 2014 Apr 14;3(2):e000588. doi: 10.1161/JAHA.113.000588.
Other Identifiers
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SHCCARD-001
Identifier Type: -
Identifier Source: org_study_id
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