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

Heart Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03486470
• Other study ID #: MBVT-0218-1
• Status: Not yet recruiting
• First received: February 28, 2018
• Last updated: March 30, 2018
• Start date: April 15, 2018
• Est. completion date: August 15, 2018

Study information

• Verified date: March 2018
• Source: Dr. Stephan Cherkezov Hospital
• Contact: Valentin Krastev, MD
• Phone: +359887868407
• Email: vgkrastev[@]abv.bg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 520
• Est. completion date: August 15, 2018
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases

Intervention

Diagnostic Test:
• Ultrasound examination of radial arteries
Measuring the diameter and the depth of two radial segments on both arms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Stephan Cherkezov Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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