Comparison of Two Radial Artery Segments Related to "Old-Fashioned" Radial and New Snuff Box Vessel Approach by US

Comparison of Two Radial Artery Segments Related to "Old-Fashioned" Radial and New Snuff Box Vessel Approach. Ultrasound Study of Both Arms

The purpose of this study is to determine if there is a difference in the size and the depth of the radial artery at the access points for established radial and new distal radial approach for the arteries of both arms

Study Overview

• Status: Unknown
• Conditions: Heart Diseases
• Intervention / Treatment: Diagnostic test: Ultrasound examination of radial arteries

Detailed Description

Radial approach for coronary and peripheral procedures is now well established due to both patient and operator preference and carries a lower risk of bleeding and mortality. The most lasting consequence of transradial procedures remains radial artery occlusion, which is mainly influenced by the artery diameter and the size of the sheath. As a new, more distal approach looms on the horizon, it is plausible to determine factors that could impact its feasibility. Since the success rate for artery cannulation depends to a great extent on the size and the depth of the artery, the current study examines both parameters, as well as whether they are influenced by variables such as sex, body mass index, handedness, or comorbidities i.e. diabetes mellitus and hypertension.

• Study Type: Observational
• Enrollment (Anticipated): 520

Contacts and Locations

• Study Contact: Name: Valentin Krastev, MD; Phone Number: +359887868407; Email: vgkrastev@abv.bg
• Study Contact Backup: Name: Haralamby Benov, MD; Email: hobenov@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients admitted to the Cardilogy Department

Description

Inclusion Criteria:

• Patients >18 years old admitted to the Cardiology Department

Exclusion Criteria:

• Previous transradial procedures
• Arm AV fistula for dialysis access
• History of upper limb peripheral arterial disease
• Hemiparesis
• Hemodynamic instability

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of ultrasound derived diameters of radial artery measured at sites related to two different transradial arterial approaches for catheterization	Measuring diameters of the radial artery at the access points for well established radial and new distal radial approach and finding or not a significant difference could have some implications for choosing the access radial site. At the end of a routine echocardiographic evaluation, four short axis measurements (one proximal and one distal on each arm) of the radial artery diameters will be done with a vascular probe.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of ultrasound derived depth of radial artery measured at sites related to two different transradial arterial approaches for catheterization	At the end of a routine echocardiographic evaluation, four measurements (one proximal and one distal on each arm) of the radial artery depth will be done with a vascular probe in a neutral position of the hand.	1 day
Impact of sex, BMI, hand-dominance or comorbidities on the size and the depth of the arterial segments	To determine if sex, BMI, hand-dominance and widespread comorbidities (hypertension and diabetes mellitus) influence the size and the depth of the radial artery	1 day

Collaborators and Investigators

• Sponsor: Dr. Stephan Cherkezov Hospital
• Investigators: Principal Investigator: Valentin Krastev, MD, Dr. Stephan Cherkezov Hospital; Principal Investigator: Haralamby Benov, MD, Dr. Stephan Cherkezov Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 15, 2018
• Primary Completion (Anticipated): August 15, 2018
• Study Completion (Anticipated): August 15, 2018

Study Registration Dates

• First Submitted: February 28, 2018
• First Submitted That Met QC Criteria: March 30, 2018
• First Posted (Actual): April 3, 2018

Study Record Updates

• Last Update Posted (Actual): April 3, 2018
• Last Update Submitted That Met QC Criteria: March 30, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: MBVT-0218-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No